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Review
.2023 May 5;5(5):CD006103.
doi: 10.1002/14651858.CD006103.pub8.

Nicotine receptor partial agonists for smoking cessation

Affiliations
Review

Nicotine receptor partial agonists for smoking cessation

Jonathan Livingstone-Banks et al. Cochrane Database Syst Rev..

Abstract

Background: Nicotine receptor partial agonists may help people to stop smoking by a combination of maintaining moderate levels of dopamine to counteract withdrawal symptoms (acting as an agonist) and reducing smoking satisfaction (acting as an antagonist). This is an update of a Cochrane Review first published in 2007.

Objectives: To assess the effectiveness of nicotine receptor partial agonists, including varenicline and cytisine, for smoking cessation.

Search methods: We searched the Cochrane Tobacco Addiction Group's Specialised Register in April 2022 for trials, using relevant terms in the title or abstract, or as keywords. The register is compiled from searches of CENTRAL, MEDLINE, Embase, and PsycINFO. SELECTION CRITERIA: We included randomised controlled trials that compared the treatment drug with placebo, another smoking cessation drug, e-cigarettes, or no medication. We excluded trials that did not report a minimum follow-up period of six months from baseline.

Data collection and analysis: We followed standard Cochrane methods. Our main outcome was abstinence from smoking at longest follow-up using the most rigorous definition of abstinence, preferring biochemically validated rates where reported. We pooled risk ratios (RRs), using the Mantel-Haenszel fixed-effect model. We also reported the number of people reporting serious adverse events (SAEs).

Main results: We included 75 trials of 45,049 people; 45 were new for this update. We rated 22 at low risk of bias, 18 at high risk, and 35 at unclear risk. We found moderate-certainty evidence (limited by heterogeneity) that cytisine helps more people to quit smoking than placebo (RR 1.30, 95% confidence interval (CI) 1.15 to 1.47; I2 = 83%; 4 studies, 4623 participants), and no evidence of a difference in the number reporting SAEs (RR 1.04, 95% CI 0.78 to 1.37; I2 = 0%; 3 studies, 3781 participants; low-certainty evidence). SAE evidence was limited by imprecision. We found no data on neuropsychiatric or cardiac SAEs. We found high-certainty evidence that varenicline helps more people to quit than placebo (RR 2.32, 95% CI 2.15 to 2.51; I2 = 60%, 41 studies, 17,395 participants), and moderate-certainty evidence that people taking varenicline are more likely to report SAEs than those not taking it (RR 1.23, 95% CI 1.01 to 1.48; I2 = 0%; 26 studies, 14,356 participants). While point estimates suggested increased risk of cardiac SAEs (RR 1.20, 95% CI 0.79 to 1.84; I2 = 0%; 18 studies, 7151 participants; low-certainty evidence), and decreased risk of neuropsychiatric SAEs (RR 0.89, 95% CI 0.61 to 1.29; I2 = 0%; 22 studies, 7846 participants; low-certainty evidence), in both cases evidence was limited by imprecision, and confidence intervals were compatible with both benefit and harm. Pooled results from studies that randomised people to receive cytisine or varenicline showed that more people in the varenicline arm quit smoking (RR 0.83, 95% CI 0.66 to 1.05; I2 = 0%; 2 studies, 2131 participants; moderate-certainty evidence) and reported SAEs (RR 0.67, 95% CI 0.44 to 1.03; I2 = 45%; 2 studies, 2017 participants; low-certainty evidence). However, the evidence was limited by imprecision, and confidence intervals incorporated the potential for benefit from either cytisine or varenicline. We found no data on neuropsychiatric or cardiac SAEs. We found high-certainty evidence that varenicline helps more people to quit than bupropion (RR 1.36, 95% CI 1.25 to 1.49; I2 = 0%; 9 studies, 7560 participants), and no clear evidence of difference in rates of SAEs (RR 0.89, 95% CI 0.61 to 1.31; I2 = 0%; 5 studies, 5317 participants), neuropsychiatric SAEs (RR 1.05, 95% CI 0.16 to 7.04; I2 = 10%; 2 studies, 866 participants), or cardiac SAEs (RR 3.17, 95% CI 0.33 to 30.18; I2 = 0%; 2 studies, 866 participants). Evidence of harms was of low certainty, limited by imprecision. We found high-certainty evidence that varenicline helps more people to quit than a single form of nicotine replacement therapy (NRT) (RR 1.25, 95% CI 1.14 to 1.37; I2 = 28%; 11 studies, 7572 participants), and low-certainty evidence, limited by imprecision, of fewer reported SAEs (RR 0.70, 95% CI 0.50 to 0.99; I2 = 24%; 6 studies, 6535 participants). We found no data on neuropsychiatric or cardiac SAEs. We found no clear evidence of a difference in quit rates between varenicline and dual-form NRT (RR 1.02, 95% CI 0.87 to 1.20; I2 = 0%; 5 studies, 2344 participants; low-certainty evidence, downgraded because of imprecision). While pooled point estimates suggested increased risk of SAEs (RR 2.15, 95% CI 0.49 to 9.46; I2 = 0%; 4 studies, 1852 participants) and neuropsychiatric SAEs (RR 4.69, 95% CI 0.23 to 96.50; I2 not estimable as events only in 1 study; 2 studies, 764 participants), and reduced risk of cardiac SAEs (RR 0.32, 95% CI 0.01 to 7.88; I2 not estimable as events only in 1 study; 2 studies, 819 participants), in all three cases evidence was of low certainty and confidence intervals were very wide, encompassing both substantial harm and benefit.

Authors' conclusions: Cytisine and varenicline both help more people to quit smoking than placebo or no medication. Varenicline is more effective at helping people to quit smoking than bupropion, or a single form of NRT, and may be as or more effective than dual-form NRT. People taking varenicline are probably more likely to experience SAEs than those not taking it, and while there may be increased risk of cardiac SAEs and decreased risk of neuropsychiatric SAEs, evidence was compatible with both benefit and harm. Cytisine may lead to fewer people reporting SAEs than varenicline. Based on studies that directly compared cytisine and varenicline, there may be a benefit from varenicline for quitting smoking, however further evidence could strengthen this finding or demonstrate a benefit from cytisine. Future trials should test the effectiveness and safety of cytisine compared with varenicline and other pharmacotherapies, and should also test variations in dose and duration. There is limited benefit to be gained from more trials testing the effect of standard-dose varenicline compared with placebo for smoking cessation. Further trials on varenicline should test variations in dose and duration, and compare varenicline with e-cigarettes for smoking cessation.

Trial registration: ClinicalTrials.govNCT01078298NCT00143325NCT01553084NCT00594204 01141855NCT01010204NCT00507728NCT02360631NCT01370356NCT00141206NCT01244061NCT01347112NCT00143364NCT01027754NCT00139750NCT01162239NCT00150228NCT00150241NCT00150254NCT00691483NCT00282984NCT00894166NCT00790569NCT00285012NCT00356967NCT00141167NCT00371813NCT02233231 00143299NCT00644969NCT00937508NCT00813917NCT00935818NCT00463918NCT00717093NCT01111149NCT00701896NCT00860028NCT00789074NCT01184664NCT01206010NCT00835900NCT00492349NCT00995033NCT00595868NCT01098305NCT01444131NCT00944554NCT00832806NCT00727103NCT01378858NCT00387946NCT00502216NCT00554840NCT00828113NCT01093937NCT01413516NCT01532232NCT01592695NCT01771627NCT01772641NCT01806779NCT01892813NCT02048917NCT02147132NCT02271919NCT00781599NCT00948649NCT00567320NCT01538394NCT01303861NCT00523445NCT00802919NCT00301145NCT00143286NCT00977249NCT00906386NCT01243203NCT01800019NCT02106637NCT02162849NCT00959972NCT01387425.

Copyright © 2023 The Authors. Cochrane Database of Systematic Reviews published by John Wiley & Sons, Ltd. on behalf of The Cochrane Collaboration.

PubMed Disclaimer

Conflict of interest statement

JL‐B is employed by the University of Oxford to work as a Managing Editor for the Cochrane Tobacco Addiction Review Group. He was not involved in the editorial process for this review. Core infrastructure funding for the Cochrane Tobacco Addiction Group is provided by the NIHR to the University of Oxford. JLB has no conflicts of interest.

TF: none known

KT published an opinion piece on varenicline (Davies 2017). KT is on the Specialist Register in the UK as a Consultant in Public Health Medicine, employed by the University of Bristol as an Associate Professor in Public Health Medicine, and currently holds Honorary status as a Consultant in Public Health at South Gloucestershire Council, and is Clinical Director for the NIHR CRN West of England. KT has no conflicts of interest.

AH: none known

AT: none known

LH: none known

NL is employed by the University of Oxford to work as a Managing Editor for the Cochrane Tobacco Addiction Review Group. She was not involved in the editorial process for this review. Core infrastructure funding for the Cochrane Tobacco Addiction Group is provided by the NIHR to the University of Oxford. NL has written pieces forThe Conversation on the findings of Cochrane Reviews assessing the effects of treatments for smoking cessation. These are evidence‐based and not based on personal opinion. NL receives funding from CRUK and the NIHR (a part of the NHS) who both have interests in people stopping smoking and run educational campaigns, and in the latter case provide treatment to encourage people to stop smoking. NL has no conflicts of interest.

Figures

1
1
Study flow diagram of searches for 2022 update
2
2
Risk of bias summary: review authors' judgements about each risk of bias item for each included study
3
3
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies
4
4
Funnel plot of comparison 6: varenicline (1.0 mg 2/d) vs placebo, outcome: 6.1 abstinence at longest follow‐up
5
5
Funnel plot of comparison 13: varenicline vs nicotine replacement therapy monotherapy, outcome: 13.1 abstinence at longest follow‐up
1.1
1.1. Analysis
Comparison 1: Cytisine vs placebo or no medication, Outcome 1: Abstinence at longest follow‐up
1.2
1.2. Analysis
Comparison 1: Cytisine vs placebo or no medication, Outcome 2: Adverse events
1.3
1.3. Analysis
Comparison 1: Cytisine vs placebo or no medication, Outcome 3: Serious adverse events
2.1
2.1. Analysis
Comparison 2: Cytisine: longer vs shorter duration, Outcome 1: Abstinence at longest follow‐up
3.1
3.1. Analysis
Comparison 3: Cytisine vs varenicline, Outcome 1: Abstinence at longest follow‐up
3.2
3.2. Analysis
Comparison 3: Cytisine vs varenicline, Outcome 2: Nausea
3.3
3.3. Analysis
Comparison 3: Cytisine vs varenicline, Outcome 3: Abnormal dreams
3.4
3.4. Analysis
Comparison 3: Cytisine vs varenicline, Outcome 4: Insomnia
3.5
3.5. Analysis
Comparison 3: Cytisine vs varenicline, Outcome 5: Headache
3.6
3.6. Analysis
Comparison 3: Cytisine vs varenicline, Outcome 6: Depression
3.7
3.7. Analysis
Comparison 3: Cytisine vs varenicline, Outcome 7: Suicidal ideation
3.8
3.8. Analysis
Comparison 3: Cytisine vs varenicline, Outcome 8: SAEs
4.1
4.1. Analysis
Comparison 4: Cytisine vs NRT, Outcome 1: Abstinence at longest follow‐up
4.2
4.2. Analysis
Comparison 4: Cytisine vs NRT, Outcome 2: Nausea
4.3
4.3. Analysis
Comparison 4: Cytisine vs NRT, Outcome 3: SAEs
5.1
5.1. Analysis
Comparison 5: Varenicline 2 mg per day vs placebo or no medication, Outcome 1: Abstinence at longest follow‐up
5.2
5.2. Analysis
Comparison 5: Varenicline 2 mg per day vs placebo or no medication, Outcome 2: Nausea
5.3
5.3. Analysis
Comparison 5: Varenicline 2 mg per day vs placebo or no medication, Outcome 3: Insomnia
5.4
5.4. Analysis
Comparison 5: Varenicline 2 mg per day vs placebo or no medication, Outcome 4: Abnormal dreams
5.5
5.5. Analysis
Comparison 5: Varenicline 2 mg per day vs placebo or no medication, Outcome 5: Headache
5.6
5.6. Analysis
Comparison 5: Varenicline 2 mg per day vs placebo or no medication, Outcome 6: Depression
5.7
5.7. Analysis
Comparison 5: Varenicline 2 mg per day vs placebo or no medication, Outcome 7: Suicidal ideation
5.8
5.8. Analysis
Comparison 5: Varenicline 2 mg per day vs placebo or no medication, Outcome 8: SAEs
5.9
5.9. Analysis
Comparison 5: Varenicline 2 mg per day vs placebo or no medication, Outcome 9: Neuropsychiatric SAEs (not deaths)
5.10
5.10. Analysis
Comparison 5: Varenicline 2 mg per day vs placebo or no medication, Outcome 10: Cardiac SAEs, including deaths
6.1
6.1. Analysis
Comparison 6: Varenicline: variations in usage, Outcome 1: Low‐dose varenicline vs placebo
6.2
6.2. Analysis
Comparison 6: Varenicline: variations in usage, Outcome 2: Higher‐dose varenicline versus lower‐dose varenicline
6.3
6.3. Analysis
Comparison 6: Varenicline: variations in usage, Outcome 3: Longer vs standard duration varenicline
6.4
6.4. Analysis
Comparison 6: Varenicline: variations in usage, Outcome 4: 6 week vs 1 week preloading
7.1
7.1. Analysis
Comparison 7: Varenicline (vs placebo or no medication) in specific patient groups, Outcome 1: Cardiovascular disease
7.2
7.2. Analysis
Comparison 7: Varenicline (vs placebo or no medication) in specific patient groups, Outcome 2: COPD
7.3
7.3. Analysis
Comparison 7: Varenicline (vs placebo or no medication) in specific patient groups, Outcome 3: Asthma
7.4
7.4. Analysis
Comparison 7: Varenicline (vs placebo or no medication) in specific patient groups, Outcome 4: Schizophrenia/bipolar/psychiatric disorder
7.5
7.5. Analysis
Comparison 7: Varenicline (vs placebo or no medication) in specific patient groups, Outcome 5: Depression
7.6
7.6. Analysis
Comparison 7: Varenicline (vs placebo or no medication) in specific patient groups, Outcome 6: Substance use disorder/ methadone‐maintained at 24 weeks
7.7
7.7. Analysis
Comparison 7: Varenicline (vs placebo or no medication) in specific patient groups, Outcome 7: Alcohol‐dependence
7.8
7.8. Analysis
Comparison 7: Varenicline (vs placebo or no medication) in specific patient groups, Outcome 8: HIV
8.1
8.1. Analysis
Comparison 8: Varenicline in specific settings/subgroups, Outcome 1: Hospital inpatients/perioperative patients
8.2
8.2. Analysis
Comparison 8: Varenicline in specific settings/subgroups, Outcome 2: Smokers with a previous quit attempt on varenicline
8.3
8.3. Analysis
Comparison 8: Varenicline in specific settings/subgroups, Outcome 3: Light or heavy smokers
9.1
9.1. Analysis
Comparison 9: Varenicline vs bupropion, Outcome 1: Abstinence at longest follow‐up
9.2
9.2. Analysis
Comparison 9: Varenicline vs bupropion, Outcome 2: Nausea
9.3
9.3. Analysis
Comparison 9: Varenicline vs bupropion, Outcome 3: Insomnia
9.4
9.4. Analysis
Comparison 9: Varenicline vs bupropion, Outcome 4: Abnormal dreams
9.5
9.5. Analysis
Comparison 9: Varenicline vs bupropion, Outcome 5: Headache
9.6
9.6. Analysis
Comparison 9: Varenicline vs bupropion, Outcome 6: Depression
9.7
9.7. Analysis
Comparison 9: Varenicline vs bupropion, Outcome 7: Suicidal ideation
9.8
9.8. Analysis
Comparison 9: Varenicline vs bupropion, Outcome 8: SAEs
9.9
9.9. Analysis
Comparison 9: Varenicline vs bupropion, Outcome 9: Neuropsychiatric SAEs (not deaths)
9.10
9.10. Analysis
Comparison 9: Varenicline vs bupropion, Outcome 10: Cardiac SAEs, including deaths
10.1
10.1. Analysis
Comparison 10: Varenicline vs NRT monotherapy, Outcome 1: Abstinence at longest follow‐up
10.2
10.2. Analysis
Comparison 10: Varenicline vs NRT monotherapy, Outcome 2: Nausea
10.3
10.3. Analysis
Comparison 10: Varenicline vs NRT monotherapy, Outcome 3: Insomnia
10.4
10.4. Analysis
Comparison 10: Varenicline vs NRT monotherapy, Outcome 4: Abnormal dreams
10.5
10.5. Analysis
Comparison 10: Varenicline vs NRT monotherapy, Outcome 5: Headache
10.6
10.6. Analysis
Comparison 10: Varenicline vs NRT monotherapy, Outcome 6: Depression
10.7
10.7. Analysis
Comparison 10: Varenicline vs NRT monotherapy, Outcome 7: Suicidal ideation
10.8
10.8. Analysis
Comparison 10: Varenicline vs NRT monotherapy, Outcome 8: SAEs
10.9
10.9. Analysis
Comparison 10: Varenicline vs NRT monotherapy, Outcome 9: Neuropsychiatric SAEs (not deaths)
10.10
10.10. Analysis
Comparison 10: Varenicline vs NRT monotherapy, Outcome 10: Cardiac SAEs, including deaths
11.1
11.1. Analysis
Comparison 11: Varenicline vs combination NRT, Outcome 1: Abstinence at longest follow‐up
11.2
11.2. Analysis
Comparison 11: Varenicline vs combination NRT, Outcome 2: Nausea
11.3
11.3. Analysis
Comparison 11: Varenicline vs combination NRT, Outcome 3: Insomnia
11.4
11.4. Analysis
Comparison 11: Varenicline vs combination NRT, Outcome 4: Abnormal dreams
11.5
11.5. Analysis
Comparison 11: Varenicline vs combination NRT, Outcome 5: Headache
11.6
11.6. Analysis
Comparison 11: Varenicline vs combination NRT, Outcome 6: Depression
11.7
11.7. Analysis
Comparison 11: Varenicline vs combination NRT, Outcome 7: Suicidal ideation
11.8
11.8. Analysis
Comparison 11: Varenicline vs combination NRT, Outcome 8: SAEs
11.9
11.9. Analysis
Comparison 11: Varenicline vs combination NRT, Outcome 9: Neuropsychiatric SAEs (not deaths)
11.10
11.10. Analysis
Comparison 11: Varenicline vs combination NRT, Outcome 10: Cardiac SAEs, including deaths
12.1
12.1. Analysis
Comparison 12: Varenicline vs e‐cigarettes, Outcome 1: Abstinence at longest follow‐up
12.2
12.2. Analysis
Comparison 12: Varenicline vs e‐cigarettes, Outcome 2: Nausea
12.3
12.3. Analysis
Comparison 12: Varenicline vs e‐cigarettes, Outcome 3: SAEs
12.4
12.4. Analysis
Comparison 12: Varenicline vs e‐cigarettes, Outcome 4: Neuropsychiatric SAEs (not deaths)
12.5
12.5. Analysis
Comparison 12: Varenicline vs e‐cigarettes, Outcome 5: Cardiac SAEs, including deaths
13.1
13.1. Analysis
Comparison 13: Dianicline vs placebo, Outcome 1: Abstinence at longest follow‐up
13.2
13.2. Analysis
Comparison 13: Dianicline vs placebo, Outcome 2: Nausea
13.3
13.3. Analysis
Comparison 13: Dianicline vs placebo, Outcome 3: Headache
13.4
13.4. Analysis
Comparison 13: Dianicline vs placebo, Outcome 4: Depression
13.5
13.5. Analysis
Comparison 13: Dianicline vs placebo, Outcome 5: Serious adverse events
13.6
13.6. Analysis
Comparison 13: Dianicline vs placebo, Outcome 6: Cardiac SAEs, including deaths
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References

References to studies included in this review

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Chengappa 2014 {published and unpublished data}
    1. Chengappa KN, Perkins KA, Brar JS, Schlicht PJ, Turkin SR, Hetrick ML, et al. Varenicline for smoking cessation in bipolar disorder: a randomized, double-blind, placebo-controlled study. Journal of Clinical Psychiatry 2014;75(7):765-72. [CENTRAL: 1014641] - PubMed
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    1. Forrest PE, Brinson AJ, Gannon JM, George TP, Perkins KA, Chengappa KN. An association between the use of hypnotics and quit status in the treatment of nicotine dependence with varenicline in bipolar disorder. Journal of Clinical Psychopharmacology 2015;35(2):199-200. - PMC - PubMed
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Cinciripini 2013 {published and unpublished data}
    1. Cinciripini PM, Green CE, Robinson JD, Karam-Hage M, Engelmann JM, Minnix JA, et al. Benefits of varenicline vs. bupropion for smoking cessation: a Bayesian analysis of the interaction of reward sensitivity and treatment. Psychopharmacology 2017;234(11):1769-79. - PMC - PubMed
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Cinciripini 2018 {published data only}
    1. Cinciripini PM, Minnix JA, Green CE, Robinson JD, Engelmann JM, Versace F, et al. An RCT with the combination of varenicline and bupropion for smoking cessation: clinical implications for front line use. Addiction 2018;113(9):1673-82. - PMC - PubMed
    1. NCT00943618. Combining varenicline and bupropion for smoking cessation.ClinicalTrials.gov/ct2/NCT00943618 (first received 22 July 2009).
Courtney 2021 {published data only}
    1. ACTRN12616001654448. A non-inferiority trial of cytisine versus varenicline for smoking cessation.http://www.who.int/trialsearch/Trial2.aspx?TrialID=ACTRN12616001654448 (first received 30 November 2016).
    1. Courtney RJ, McRobbie H, Tutka P, Weaver NA, Petrie D, Mendelsohn CP, et al. Effect of cytisine vs varenicline on smoking cessation: a randomized clinical trial. JAMA 2021;326(1):56-64. - PMC - PubMed
    1. Thomas D, Farrell M, McRobbie H, Tutka P, Petrie D, West R, et al. The effectiveness, safety and cost-effectiveness of cytisine versus varenicline for smoking cessation in an Australian population: a study protocol for a randomized controlled non-inferiority trial. Addiction 2019;114(5):923-33. - PubMed
Cox 2022 {published data only}
    1. Cox LS, Nollen NL, Mayo MS, Faseru B, Greiner A, Ellerbeck EF, et al. Effect of varenicline added to counseling on smoking cessation among African American daily smokers: the Kick It at Swope IV randomized clinical trial. JAMA 2022;327(22):2201-9. [DOI: 10.1001/jama.2022.8274.] - DOI - PMC - PubMed
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    1. NCT02360631. Advancing tobacco use treatment for African American smokers.ClinicalTrials.gov/show/NCT02360631 (first received 10 February 2015).
De Dios 2012 {published data only}
    1. De Dios MA, Anderson BJ, Stanton C, Audet DA, Stein M. Project Impact: a pharmacotherapy pilot trial investigating the abstinence and treatment adherence of Latino light smokers. Journal of Substance Abuse Treatment 2012;43(3):322-30. [CENTRAL: 836798] [EMBASE: 2012562711] [PMID: ] - PMC - PubMed
Dogar 2020 {published data only}
    1. Boeckmann M, Nohavova I, Dogar O, Kralikova E, Pankova A, Zvolska K, et al. Protocol for the mixed-methods process and context evaluation of the TB & Tobacco randomised controlled trial in Bangladesh and Pakistan: a hybrid effectiveness-implementation study. BMJ Open 2018;8(3):e019878. - PMC - PubMed
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    1. Dogar O, Keding A, Gabe R, Marshall AM, Huque R, Barua D, et al. Cytisine for smoking cessation in patients with tuberculosis: a multicentre, randomised, double-blind, placebo-controlled phase 3 trial. Lancet Global Health 2020;8(11):e1408-17. - PubMed
    1. ISRCTN43811467. Tuberculosis (TB) and tobacco.www.isrctn.com/ISRCTN43811467 (first received 23 March 2016).
    1. Siddiqi K, Keding A, Marshall AM, Dogar O, Li J, Huque R, et al. Effect of quitting smoking on health outcomes during treatment for tuberculosis: secondary analysis of the TB & Tobacco Trial. Thorax 2021;7:74-8. - PubMed
EAGLES 2016 {published and unpublished data}
    1. Anthenelli R, Benowitz N, West R, St Aubin L, McRae T, Lawrence D, et al. Reports of suicidal ideation and behavior in the EAGLES trial. Proceedings of the Society for Research on Nicotine and Tobacco, USA 3rd - 5th March 2016;SYM5D:8.
    1. Anthenelli RM, Benowitz NL, West R, St Aubin L, McRae T, Lawrence D, et al. Neuropsychiatric safety and efficacy of varenicline, bupropion, and nicotine patch in smokers with and without psychiatric disorders (EAGLES): a double-blind, randomised, placebo-controlled clinical trial. Lancet 2016;387(10037):2507-20. [DOI: ] - PubMed
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    1. Ayers CR, Heffner JL, Russ C, Lawrence D, McRae T, Evins AE, et al. Efficacy and safety of pharmacotherapies for smoking cessation in anxiety disorders: subgroup analysis of the randomized, active- and placebo-controlled EAGLES trial. Depression and Anxiety 2020;37(3):247-60. - PMC - PubMed
    1. Baker CL, Pietri G. A cost-effectiveness analysis of varenicline for smoking cessation using data from the EAGLES trial. ClinicoEconomics and outcomes research 2018;10:67-74. - PMC - PubMed
Ebbert 2015 {published and unpublished data}
    1. Bastian H. Comment on Ebbert 2015 'Reduce to Quit' trial.www.ncbi.nlm.nih.gov/pubmed/?term=25688780 Feb 18 2015 (accessed 11 June 2015).
    1. Ebbert JO, Hughes JR, West RJ, Rennard SI, Russ C, McRae TD, et al. Effect of varenicline on smoking cessation through smoking reduction: a randomized clinical trial. JAMA 2015;313(7):687-94. [CENTRAL: 1050651] [PMID: ] - PMC - PubMed
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    1. Nakamura M, Abe M, Ohkura M, Treadow J, Yu CR, Park PW. Efficacy of varenicline for cigarette reduction before quitting in Japanese smokers: a subpopulation analysis of the reduce to quit trial. Clinical Therapeutics 2017;39(4):863-72. - PubMed
Ebbert 2016 {published data only}
    1. Ebbert JO, Croghan IT, Hurt RT, Schroeder DR, Hays JT. Varenicline for smoking cessation in light smokers. Nicotine & Tobacco Research 2016;18(10):2031-5. - PMC - PubMed
Fouz‐Roson 2017 {published data only}
    1. Fouz-Roson N, Montemayor-Rubio T, Almadana-Pacheco V, Montserrat-Garcia S, Gomez-Bastero AP, Romero-Munoz C, et al. Effect of 0.5 mg versus 1 mg varenicline for smoking cessation: a randomized controlled trial. Addiction 2017;112(9):1610-9. - PubMed
    1. Roson NF, Panadero-Paz C, Almadana-Pacheco V, Benito-Bernaldez C, Rodriguez-Martin PJ, Montemayor-Rubio T. Influence of psychiatric disorders in patients treated with varenicline. European Respiratory Journal 2017;50:PA4478.
    1. Roson NF, Panadero-Paz C, Benito-Bernaldez C, Rodriguez-Martin PJ, Almadana-Pacheco V, Montemayor-Rubio T. Influence of respiratory and cardiovascular diseases on smoking cessation. European Respiratory Journal 2017;50 Suppl 61:PA2987.
    1. Roson NF, Panadero-Paz C, Benito-Bernaldez C, Rodriguez-Martin PJ, Romero-Munoz C, Rubio TM. Short-term low-dose vs standard-dose varenicline therapy for smoking cessation: a randomized controlled trial. European Respiratory Journal 2017;50:PA4480.
Gonzales 2006 {published data only}
    1. Chen LS, Baker TB, Jorenby D, Piper M, Saccone N, Johnson E, et al. Genetic variation (CHRNA5), medication (combination nicotine replacement therapy vs. varenicline), and smoking cessation. Drug and Alcohol Dependence 2015;154:278-82. - PMC - PubMed
    1. Gonzales D, Jorenby DE, Brandon T, Arteaga C, Lee TC. Delayed quitting, lapse recovery and long-term outcomes for quitters taking varenicline, bupropion and placebo. Society for Research on Nicotine and Tobacco Annual Meeting, Portland OR, Feb 27-March 1st 2008.
    1. Gonzales D, Jorenby DE, Brandon TH, Arteaga C, Lee TC. Emergent adverse psychiatric symptoms by therapy during 12 weeks of treatment with varenicline, bupropion SR, or placebo for smoking cessation. Society for Research on Nicotine and Tobacco Europe: Rome, September 23-26 2008.
    1. Gonzales D, Jorenby DE, Brandon TH, Arteaga C, Lee TC. Immediate versus delayed quitting and rates of relapse among smokers treated successfully with varenicline, bupropion SR or placebo. Addiction 2010;105(11):2002-13. [DOI: 10.1111/j.1360-0443.2010.03058.x] - DOI - PMC - PubMed
    1. Gonzales D, Rennard SI, Nides M, Oncken C, Azoulay S, Billing CB et al. Varenicline, an α4ß2 nicotinic acetylcholine receptor partial agonist, vs sustained-release bupropion and placebo for smoking cessation. JAMA 2006;296(1):47-55. - PubMed
Gonzales 2014 {published and unpublished data}
    1. Gonzales D, Hajek P, Pliamm L, Nackaerts K, Tseng L-J, McRae TD, et al. Retreatment with varenicline for smoking cessation in smokers who have previously taken varenicline: a randomized, placebo-controlled trial. Clinical Pharmacology and Therapeutics 2014;96(3):390-6. [CENTRAL: 1014162] [EMBASE: 2014565570] [PMID: ] - PMC - PubMed
    1. NCT01244061. A multi-national study to assess how effective and safe the smoking cessation medicine varenicline is in smokers who have already tried varenicline in the past as a prescription medicine from their usual healthcare provider.clinicaltrials.gov/ct2/show/NCT01244061 (first received 19th November 2010). [ClinicalTrials.gov ID NCT01244061]
Gray 2019 {published data only}
    1. Gray KM, Baker NL, McClure EA, Tomko RL, Squeglia LM, Saladin ME, et al. Efficacy and safety of varenicline for adolescent smoking cessation: a randomized clinical trial. JAMA Pediatrics 2019;173(12):1146-53. - PMC - PubMed
    1. McClure EA, Baker NL, Hood CO, Tomko RL, Squeglia LM, Flanagan JC, et al. Cannabis and alcohol co-use in a smoking cessation pharmacotherapy trial for adolescents and emerging adults. Nicotine & Tobacco Research 2019;22(8):1374-82. - PMC - PubMed
    1. NCT01509547. A randomized controlled trial of varenicline for adolescent smoking cessation.ClinicalTrials.gov/show/NCT01509547 (first received 13th January 2012).
Heydari 2012 {published data only}138901111878N2
    1. Heydari G, Talischi F, Tafti SF, Masjedi MR. Quitting smoking with varenicline: parallel, randomised efficacy trial in Iran. International Journal of Tuberculosis and Lung Disease 2012;16(2):268-72. [CENTRAL: 814663] [EMBASE: 2012026893] [PMID: ] - PubMed
    1. IRCT138901111878N2. Evaluation of the effect of champ-ix in smoking cessation in smokers in Tehran.www.irct.ir/trial/1473 (first received 12 October 2010).
Hong 2015 {published data only}
    1. Hong H, Wang W, Chen L. Study on effect of 5A intervention method combined with varenicline for smoking cessation of COPD patients in stable stage. Chinese Nursing Research 2015;29(2C):667-70.
Hurt 2018 {unpublished data only}
    1. Hurt RT, Ebbert JO, Croghan IT, Schroeder DR, Hurt RD, Hays JT. Varenicline for tobacco-dependence treatment in alcohol-dependent smokers: a randomized controlled trial. Drug and Alcohol Dependence 2018;184:12-7. - PMC - PubMed
    1. NCT01347112. Varenicline treatment for active alcoholic smokers.clinicaltrials.gov/ct2/show/NCT01347112 (first received 4 May 2011).
Ikonomidis 2017 {published data only}
    1. Ikonomidis I, Kourea K, Vlastos D, Marinou M, Vlachos S, Varoudi M, et al. Varenicline vs. nicotine replacement therapy: a prospective study of changes in arterial stiffness, endothelial glycocalyx and oxidative stress in smokers during 1 year follow-up. European Heart Journal 2016;Suppl 1 European Society of Cardiology, ESC Congress 2016. Italy. 37:553-4.
    1. Ikonomidis I, Marinou M, Vlastos D, Kourea K, Andreadou I, Liarakos N, et al. Effects of varenicline and nicotine replacement therapy on arterial elasticity, endothelial glycocalyx and oxidative stress during a 3-month smoking cessation program. Atherosclerosis 2017;262:123-30. - PubMed
Ioakeimidis 2018 {published data only}
    1. Ioakeimidis N, Vlachopoulos C, Georgakopoulos C, Abdelrasoul M, Skliros N, Katsi V, et al. Smoking cessation rates with varenicline and electronic cigarettes in relapsed smokers with a history of acute coronary syndrome. European Heart Journal 2018;Suppl 1: European Society of Cardiology Congress, ESC 2018. Germany. 39:242.
Johns 2017a {published data only}
    1. Johns D. Randomised controlled trial comparing varenicline plus counselling and brief counselling alone on smoking cessation in patients prone to lung cancer using carbon monoxide moniter. Supportive Care in Cancer 2017;2 Suppl 1: 2017 international MASCC/ISOO symposium: supportive care in cancer. USA:S52.
Johns 2017b {published data only}
    1. Johns DA. The efficacy of combination therapy with varenicline and bupropion for smoking cessation. Annals of Oncology 2017;Suppl 2: 7th European Lung Cancer Conference, ELCC 2017. Switzerland. 28:iii6-7.
Jorenby 2006 {published data only}
    1. Jorenby DE, Hays JT, Rigotti NA, Azoulay S, Watsky EJ, Williams KE, et al. Efficacy of varenicline, an α4ß2 nicotinic acetylcholine receptor partial agonist, vs placebo or sustained-release bupropion for smoking cessation. JAMA 2006;296(1):56-63. - PubMed
    1. O'Brien CP. A second varenicline trial. Current Psychiatry Reports 2007;9(5):348-8. - PubMed
King 2022 {published data only}
    1. King A, Vena A, Wit H, Grant JE, Cao D. Effect of combination treatment with varenicline and nicotine patch on smoking cessation among smokers who drink heavily: a randomized clinical trial. JAMA Network Open 2022;5(3):e220951. - PMC - PubMed
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Le Mao 2020 {published data only}
    1. Le Mao R, Tromeur C, Paleiron N, Sanchez O, Gagnadoux F, Jouneau S, et al. Effect of early initiation of varenicline on smoking cessation in COPD patients admitted for exacerbation: the save randomized clinical trial. COPD 2020;17(1):7-14. - PubMed
    1. NCT01694732. Efficacy of varenicline associated with intensive counselling versus placebo of varenicline associated with intensive counselling on smoking cessation at the acute phase of an exacerbation of chronic obstructive pulmonary disease (COPD). A multicenter randomized double-blind trial.ClinicalTrials.gov/show/NCT01694732 (first received 27 September 2012).
    1. Tromeur C, Le Mao R, Couturand F. Effect of varenicline on smoking cessation in COPD patients recovering from exacerbation: a randomized trial. Fundamental & Clinical Pharmacology 2018;32 Suppl 1:32.
Lerman 2015 {published data only}
    1. Ashare RL, Lerman C, Tyndale RF, Hawk LW, George TP, Cinciripini P, et al. Sleep disturbance during smoking cessation: withdrawal or side effect of treatment? Journal of Smoking Cessation 2017;12(2):63-70. - PMC - PubMed
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    1. Chenoweth MJ, Novalen M, Hawk LWJ, Schnoll RA, George TP, Cinciripini PM, et al. Known and novel sources of variability in the nicotine metabolite ratio in a large sample of treatment-seeking smokers. Cancer Epidemiology, Biomarkers & Prevention 2014;23(9):1773-82. - PMC - PubMed
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Littlewood 2017 {published data only}
    1. Bidwell LC, Karoly HC, Hutchison KE, Bryan AD. ADHD symptoms impact smoking outcomes and withdrawal in response to Varenicline treatment for smoking cessation. Drug and Alcohol Dependence 2017;179:18-24. - PMC - PubMed
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Mercie 2018 {published data only}
    1. Mercie P, Arsandaux J, Katlama C, Ferret S, Beuscart A, Spadone C, et al. Efficacy and safety of varenicline for smoking cessation in people living with HIV in France (ANRS 144 Inter-ACTIV): a randomised controlled phase 3 clinical trial. Lancet HIV 2018;5(3):e126-35. - PubMed
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Nahvi 2014a {published and unpublished data}
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Nakamura 2007 {published data only}
    1. Fagerström K, Nakamura M, Cho H, Tsa S, Wang C, Davies S, et al. Varenicline treatment for smoking cessation in Asian populations: a pooled analysis of placebo-controlled trials conducted in six Asian countries. Current Medical Research & Opinion 2010;26(9):2165-73. - PubMed
    1. Igarashi A, Takuma H, Fukada T, Tsutani K. Cost-utility analysis of varenicline, an oral smoking-cessation drug, in Japan. Pharmacoeconomics 2009;27(3):247-61. - PubMed
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NCT01162239 {published data only}
    1. NCT01162239. Maintaining nonsmoking.ClinicalTrials.gov/show/NCT01162239 (first received 14 July 2010).
Niaura 2008 {published data only}
    1. Niaura R, Taylor Hays J, Jorenby DE, Leone FT, Pappas JE, Reeves KR, et al. The efficacy and safety of varenicline for smoking cessation using a flexible dosing strategy in adult smokers: a randomized controlled trial. Current Medical Research and Opinion 2008;24(7):1931-41. [clinicaltrials.gov ID: NCT00150228] - PubMed
Nides 2006 {published data only}
    1. Nides M, Glover ED, Reus VI, Christen AG, Make BJ, Billing CB, et al. Varenicline versus bupropion SR or placebo for smoking cessation: a pooled analysis. American Journal of Health Behavior 2008;32(6):664-75. - PubMed
    1. Nides M, Oncken C, Gonzalez D, Rennard S, Watsky EJ, Anziano R, et al. Smoking cessation with varenicline, a selective α4β2 nicotinic receptor partial agonist. Archives of Internal Medicine 2006;166:1561-8. - PubMed
    1. Oncken C, Watsky E, Reeves K, Anziano R. Varenicline is efficacious and well tolerated in promoting smoking cessation: results from a 7-week, randomized, placebo- and bupropion-controlled trial [POS1-047]. Society for Research on Nicotine and Tobacco 11th Annual Meeting, 20-23 March 2005; Prague, Czech Republic 2005.
O'Malley 2018 {published data only}
    1. Bold KW, Zweben A, Fucito LM, Piepmeier ME, Muvvala S, Wu R, et al. Longitudinal findings from a randomized clinical trial of varenicline for alcohol use disorder with comorbid cigarette smoking. Alcoholism, Clinical and Experimental Research 2019;43(5):937-44. - PMC - PubMed
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Oncken 2006 {published data only}
    1. Oncken C, Gonzales D, Nides M, Rennard S, Watsky E, Billing CB, et al. Efficacy and safety of the novel selective nicotinic acetylcholine receptor partial agonist, varenicline, for smoking cessation. Archives of Internal Medicine 2006;166(15):1571-7. [CENTRAL: 567305] [EMBASE: 2006391945] [PMID: ] - PubMed
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Pastorino 2022 {published and unpublished data}
    1. Pastorino U, Ladisa V, Trussardo S, Sabia F, Rolli L, Valsecchi C, et al. Cytisine therapy improved smoking cessation in the randomized SMILE lung cancer screening trial. Journal of Thoracic Oncology 2022;17(11):1276-86. [DOI: 10.1016/j.jtho.2022.07.007.] - DOI - PubMed
Qin 2021 {published data only}
    1. ChiCTR1900021400. Individual tobacco cessation research based on nicotine metabolite ratio in smoking patients with chronic obstructive pulmonary disease: a randomized controlled trial.https://trialsearch.who.int/Trial2.aspx? TrialID=ChiCTR1900021400 (first received 19 February 2019).
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Rennard 2012 {published and unpublished data}
    1. Hughes JR, Russ C, Messig MA. Association of deferring a quit attempt with smoking cessation success: a secondary analysis. Journal of Substance Abuse Treatment 2014;46(2):264-7. [CENTRAL: 911546] [EMBASE: 2013742404] [PMID: ] - PubMed
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Rigotti 2010 {published data only}
    1. Ockene I, Salmoirago-Blotcher E. Varenicline for smoking cessation in patients with coronary heart disease [editorial]. Circulation 2010;121(2):188-90. - PubMed
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Rohsenow 2017 {published data only}
    1. Martin RA, Rohsenow DJ, Tidey JW. Smokers with opioid use disorder may have worse drug use outcomes after varenicline than nicotine replacement. Journal of Substance Abuse Treatment 2019;104:22-7. - PMC - PubMed
    1. NCT00756275. Varenicline and motivational advice for smokers with substance use disorders.ClinicalTrials.gov/ct2/show/NCT00756275 (first received 22 September 2008). [ClinicalTrials.gov ID NCT00756275]
    1. Rohsenow D, Tidey JW, Martin RA, Colby S, Monti PM. Varenicline versus nicotine patch plus brief advice for sober smokers in substance treatment. Drug and Alcohol Dependence 2015;156:e191-2.
    1. Rohsenow DJ, Tidey JW, Martin RA, Colby SM, Monti PM. Varenicline helps smokers with SUD stop smoking without harming recovery (POS5-63). Society for Research on Nicotine and Tobacco 21st Annual Meeting February 25-28 Philadelphia 2015.
    1. Rohsenow DJ, Tidey JW, Martin RA, Colby SM, Swift RM, Leggio L, et al. Varenicline versus nicotine patch with brief advice for smokers with substance use disorders with or without depression: effects on smoking, substance use and depressive symptoms. Addiction 2017;112(10):1808-20. - PubMed
Rose 2013 {unpublished data only}
    1. NCT00894166. Evaluation of a tailored smoking cessation treatment algorithm based on initial treatment response and genotype (ConNIC3).clinicaltrials.gov/ct2/show/NCT00894166 (first received 6 May 2009).
    1. Rose JE, Behm FM. Adapting smoking cessation treatment according to initial response to precessation nicotine patch. American Journal of Psychiatry 2013;170(8):860-7. [CENTRAL: 873084] [EMBASE: 2013550171] [PMID: ] - PMC - PubMed
    1. Uhl GR, Walther D, Musci R, Fisher C, Anthony JC, Storr CL, et al. Smoking quit success genotype score predicts quit success and distinct patterns of developmental involvement with common addictive substances. Molecular Psychiatry 2014;19(1):50-4. [PMID: ] - PMC - PubMed
Scharfenberg 1971 {published data only}
    1. Benndorf S, Kempe G, Scharfenberg G, Wendekamm R, Winkelvoss E. Results of smoking cessation treatment with cytisin (Tabex®) [Ergebnisse der medikamentösen raucherentwöhnung mit cytisin (Tabex®)]. Das Deutsche Gesundheitwesen 1968;23(44):2092-6. - PubMed
    1. Benndorf S, Scharfenberg G, Kempe G, Wendekamm R, Winkelvoss E. Smoking cessation treatment with cytisin (Tabex®): half-yearly outcomes for former smokers abstinent at four weeks from beginning of treatment [Medikamentöse raucherentwöhnung mit cytisin (Tabex®): ergebnisse der halbjahresbefragung bei den vier wochen nach kurbeginn abstinenten ehemaligen rauchern]. Das Deutsche Gesundheitwesen 1970;24:774-6. - PubMed
    1. Benndorf S, Scharfenberg G, Kempe G, Winkelvoss E, Wendekamm R. Further reports on a double blind trial of the Bulgarian cytisine compound Tabex® on 1214 smokers wishing to quit and practical experience in conducting clinics for such smokers [Weitere mitteilungen über einen doppelten blindversuch mit dem cytisinhaltigen bulgarischen präparat Tabex an 1214 entwöhnungswilligen rauchern und praktische erfahrungen bei der durchfürung einer sprechstunde für entwöhnungswillige raucher]. Das Deutsche Gesundheitswesen 1969;24:1135-40.
    1. Scharfenberg G, Benndorf S, Kempe G. Cytisine (Tabex®) as a treatment for smoking cessation [Cytisin (Tabex®) als medikamentöse raucherentwöhnungshilfe]. Das Deutsche Gesundheitwesen 1971;26(10):463-5. - PubMed
Schnoll 2019 {published data only}
    1. Carroll AJ, Veluz-Wilkins AK, Blazekovic S, Kalhan R, Leone FT, Wileyto El, et al. Cancer-related disease factors and smoking cessation treatment: analysis of an ongoing clinical trial. Psycho-oncology 2018;27(2):471-6. - PMC - PubMed
    1. Crawford G, Weisbrot J, Bastian J, Flitter A, Jao NC, Carroll A, et al. Predictors of varenicline adherence among cancer patients treated for tobacco dependence and its association with smoking cessation. Nicotine & Tobacco Research 2019;21(8):1135-9. - PMC - PubMed
    1. May JR, Jao NC, McCarter K, Klass E, Pearman T, Leone F, et al. Change in health-related quality of life among individuals with cancer undergoing smoking cessation treatment involving varenicline. Oncology Nursing Forum 2021;48(1):112-20. - PMC - PubMed
    1. NCT01756885. Extended duration varenicline for smoking among cancer patients: a clinical trial.ClinicalTrials.gov/show/NCT01756885 (first received 28 December 2012).
    1. Schnoll R, Leone F, Veluz-Wilkins A, Miele A, Hole A, Jao N C, et al. A randomized controlled trial of 24 weeks of varenicline for tobacco use among cancer patients: efficacy, safety, and adherence. Psycho-oncology 2019;28(3):561-9. - PMC - PubMed
Stein 2013 {unpublished data only}
    1. De Dios MA, Anderson BJ, Caviness CM, Stein MD. Early quit days among methadone-maintained smokers in a smoking cessation trial. Nicotine & Tobacco Research 2014;16(11):1463-9. [CENTRAL: 1042497] - PMC - PubMed
    1. NCT00790569. Varenicline versus nicotine replacement for methadone-maintained smokers.https://clinicaltrials.gov/ct2/show/NCT00790569 (first received 13 November 2008).
    1. Stein MD, Caviness CM, Kurth ME, Audet D, Olson J, Anderson BJ. Varenicline for smoking cessation among methadone-maintained smokers: a randomized clinical trial. Drug and Alcohol Dependence 2013;133(2):486-93. [CENTRAL: 870955] [EMBASE: 2013694276] [PMID: ] - PMC - PubMed
Steinberg 2011 {published data only}
    1. Steinberg MB, Randall J, Greenhaus S, Schmelzer AC, Richardson DL, Carson JL. Tobacco dependence treatment for hospitalized smokers: a randomized, controlled, pilot trial using varenicline. Addictive Behaviors 2011;36(12):1127-32. - PubMed
Steinberg 2018 {published data only}
    1. NCT01308736. Varenicline-aided cigarette reduction in smokers not ready to quit.ClinicalTrials.gov/show/NCT01308736 (first received 4 March 2011).
    1. Steinberg ML, Lu SE, Williams JM. Varenicline for smoking reduction in smokers not yet ready to quit: a double-blind, proof-of-concept randomized clinical trial. Addictive Behaviors 2018;84:20-6. - PubMed
Tashkin 2011 {published data only}
    1. Antoniu SA, Trofor AC. Varenicline for smoking cessation intervention in chronic obstructive pulmonary disease. Expert Opinion on Pharmacotherapy 2011;12(16):2595-7. - PubMed
    1. Kotz D, Van Schayck OC. What justifies a placebo-controlled trial of varenicline for smoking cessation in patients with COPD? [comment]. Chest 2011;139:968-9. - PubMed
    1. Tashkin DP, Rennard S, Hays JT, Ma W, Lawrence D, Lee TC. Effects of varenicline on smoking cessation in mild-to-moderate COPD: a randomized controlled trial. Chest 2011;139:591-9. - PubMed
    1. Tashkin DP, Rennard S, Taylor Hays J, Lawrence D, Marton JP, Lee TC. Lung function and respiratory symptoms in a 1-year randomized smoking cessation trial of varenicline in COPD patients. Respiratory Medicine 2011;105(11):1682-90. [CENTRAL: 811557] [6378] [PMID: ] - PubMed
Tonstad 2011 {published data only}
    1. Tonstad S, Holme I, Tønnesen P. Dianicline, a novel α4β2 nicotinic acetylcholine receptor partial agonist, for smoking cessation: a randomized placebo-controlled clinical trial. Nicotine & Tobacco Research 2011;13(1):1-6. - PubMed
Tsai 2007 {published data only}
    1. Fagerström K, Nakamura M, Cho H, Tsa S, Wang C, Davies S, et al. Varenicline treatment for smoking cessation in Asian populations: a pooled analysis of placebo-controlled trials conducted in six Asian countries. Current Medical Research & Opinion 2010;26(9):2165-73. - PubMed
    1. Tsai S-T, Cho H-J, Cheng H-S, Kim C-H, Hsueh K-C, Billing CB, et al. A randomized, placebo-controlled trial of varenicline, a selective α4β2 nicotinic acetylcholine receptor partial agonist, as a new therapy for smoking cessation in Asian smokers. Clinical Therapeutics 2007;29(6):1027-39. - PubMed
Tsukahara 2010 {published data only}
    1. Fujiwara H. Smoking is a disease and smokers are patients. Circulation Journal 2010;74(4):628-9. - PubMed
    1. Tsukahara H, Noda K, Keijiro S. A randomized controlled open comparative trial of varenicline vs nicotine patch in adult smokers. Circulation Journal 2010;74(4):771-8. - PubMed
Tuisku 2016 {published data only}
    1. NCT01531049. Smoking cessation in young adults in Northern Finland.ClinicalTrials.gov/show/NCT01531049 (first received 10 February 2012).
    1. Tuisku A, Salmela M, Nieminen P, Toljamo T. Varenicline and nicotine patch therapies in young adults motivated to quit smoking: a randomized, placebo-controlled, prospective study. Basic & Clinical Pharmacology & Toxicology 2016;119(1):78-84. - PubMed
Tulloch 2016 {published data only}
    1. Clyde M, Pipe A, Els C, Reid R, Fu A, Clark A, et al. Nicotine metabolite ratio and smoking outcomes using nicotine replacement therapy and varenicline among smokers with and without psychiatric illness. Journal of Psychopharmacology 2018;32(9):979-85. - PubMed
    1. Clyde M, Pipe A, Els C, Reid R, Tulloch H. Factor structure of the Smoking Cessation Self-Efficacy Questionnaire among smokers with and without a psychiatric diagnosis. Psychology of Addictive Behaviors 2017;31(2):162-70. - PubMed
    1. NCT01623505. Reducing cardiovascular disease by combining smoking cessation pharmacotherapy and behavioural counselling.clinicaltrials.gov/ct2/show/NCT01623505 (first received 20 June 2012).
    1. Tulloch H, Pipe A, Els C, Aitken D, Clyde M, Corran B, et al. Flexible and extended dosing of nicotine replacement therapy or varenicline in comparison to fixed dose nicotine replacement therapy for smoking cessation: rationale, methods and participant characteristics of the FLEX trial. Contemporary Clinical Trials 2014;38(2):304-13. [CENTRAL: 999078] [EMBASE: 2014493992] - PubMed
    1. Tulloch HE, Pipe AL, Clyde MJ, Reid RD, Els C. The quit experience and concerns of smokers with psychiatric illness. American Journal of Preventive Medicine 2016;50(6):709-18. - PubMed
Vinnikov 2008 {published data only}
    1. Vinnikov D, Brimkulov N, Burjubaeva A. A double-blind, randomised, placebo-controlled trial of cytisine for smoking cessation in medium-dependent workers. Journal of Smoking Cessation 2008;3(1):57-62.
Walker 2014 {published data only}
    1. Walker N, Howe C, Bullen C, McRobbie H, Glover M, Parag V, et al. Study protocol for a non-inferiority trial of cytisine versus nicotine replacement therapy in people motivated to stop smoking. BMC Public Health 2011;11(1):880. [CENTRAL: 814611] [EMBASE: 22104038] [6430] [PMID: ] - PMC - PubMed
    1. Walker N, Howe C, Glover M, McRobbie H, Barnes J, Nosa V, et al. Cytisine versus nicotine for smoking cessation. New England Journal of Medicine 2014;371(25):2353-62. [CENTRAL: 1037839] [EMBASE: 2014610901] - PubMed
Walker 2021 {published data only}
    1. NCT02957786. Cytisine versus varenicline for smoking cessation.clinicaltrials.gov/show/NCT02957786 (first received 8 November 2016).
    1. Walker N, Smith B, Barnes J, Verbiest M, Kurdziel T, Parag V, et al. Cytisine versus varenicline for smoking cessation for Maori (the indigenous people of New Zealand) and their extended family: protocol for a randomized non-inferiority trial. Addiction 2019;114(2):344-52. - PMC - PubMed
    1. Walker N, Smith B, Barnes J, Verbiest M, Parag V, Pokhrel S, et al. Cytisine versus varenicline for smoking cessation in New Zealand indigenous Maori: a randomized controlled trial. Addiction 2021;116(10):2847-58. - PMC - PubMed
Wang 2009 {published data only}
    1. Fagerström K, Nakamura M, Cho H, Tsa S, Wang C, Davies S, et al. Varenicline treatment for smoking cessation in Asian populations: a pooled analysis of placebo-controlled trials conducted in six Asian countries. Current Medical Research & Opinion 2010;26(9):2165-73. - PubMed
    1. Wang C, Xiao D, Chan KP, Pothirat C, Garza D, Davies S. Varenicline for smoking cessation: a placebo-controlled, randomized study. Respirology 2009;14(3):384-92. [clinicaltrials.gov ID: NCT00371813] - PubMed
West 2011 {published data only}37568749
    1. West R, Zatonski W, Cedzynska M, Lewandowska D, Pazik J, Aveyard PA, et al. Placebo-controlled trial of cytisine for smoking cessation. New England Journal of Medicine 2011;365:1193-200. [Current Controlled Trials ID: ISRCTN37568749] - PubMed
    1. West R, Zatonski W. Cytisine increased smoking cessation in adults. Annals of Internal Medicine 2012;156(2):JC1-6. [CENTRAL: 897954] [EMBASE: 2012033460] - PubMed
Westergaard 2015 {published data only}
    1. Westergaard CG, Porsbjerg C, Backer V. The effect of smoking cessation on airway inflammation in young asthma patients. Clinical & Experimental Allergy 2013;44:353-61. - PubMed
    1. Westergaard CG, Porsbjerg C, Backer V. The effect of varenicline on smoking cessation in a group of young asthma patients. American Journal of Respiratory and Critical Care Medicine 2014;189:A1091. - PubMed
    1. Westergaard CG, Porsbjerg C, Backer V. The effect of varenicline on smoking cessation in a group of young asthma patients. Respiratory Medicine 2015;109(11):1416-22. [DOI: 10.1016/j.rmed.2015.07.017] - DOI - PubMed
Williams 2007 {published and unpublished data}
    1. Reeves K, Watsky E, Williams K, Azoulay S, Billing B, Gong J. The safety of varenicline taken for 52 weeks for smoking cessation [RPOS3-54]. Society for Research on Nicotine and Tobacco 12th Annual Conference Orlando Fla, USA 2006.
    1. Spangler JG, Williams KE, Reeves KR, Billing CB, Pennington AM, Gong J. Comment and reply: a double-blind study evaluating the long-term safety of varenicline for smoking cessation. Current Medical Research and Opinion 2008;24(2):577-9. - PubMed
    1. Williams KE, Reeves KR, Billing CB, Pennington AM, Gong J. A double-blind study evaluating the long-term safety of varenicline for smoking cessation. Current Medical Research and Opinion 2007;23(4):793-801. - PubMed
Williams 2012 {unpublished data only}
    1. NCT00644969. Smoking cessation study for patients with schizophrenia or schizoaffective disorder.clinicaltrials.gov/ct2/show/NCT00644969 (first received 27 March 2008).
    1. Williams JM, Anthenelli RM, Morris CD, Treadow J, Thompson JR, Yunis C, et al. A randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of varenicline for smoking cessation in patients with schizophrenia or schizoaffective disorder. Journal of Clinical Psychiatry 2012;73(5):654-60. [CENTRAL: 836870] [EMBASE: 2012321245] [PMID: ] - PubMed
Windle 2018 {published data only}
    1. Dehghani P, Habib B, Windle SB, Roy N, Old W, Grondin FR, et al. Smokers and postcessation weight gain after acute coronary syndrome. Journal of the American Heart Association 2017;6(4):e004785. - PMC - PubMed
    1. Eisenberg MJ, Windle SB, Roy N, Old W, Grondin F, Bata I, et al. Varenicline for smoking cessation in hospitalized patients with acute coronary syndrome. Circulation 2016;133(1):21-30. - PubMed
    1. NCT00794573. Evaluation of varenicline (Champix) in smoking cessation for patients post-acute coronary syndrome (EVITA) trial (EVITA).clinicaltrials.gov/ct2/show/NCT00794573 (first received 20 November 2008).
    1. Windle SB, Bata I, Madan M, Abramson BL, Eisenberg MJ. A randomized controlled trial of the efficacy and safety of varenicline for smoking cessation after acute coronary syndrome: design and methods of the Evaluation of Varenicline in Smoking Cessation for Patients Post-Acute Coronary Syndrome trial. American Heart Journal 2015;170(4):635-40. - PubMed
    1. Windle SB, Dehghani P, Roy N, Old W, Grondin FR, Bata I, et al. Smoking abstinence 1 year after acute coronary syndrome: follow-up from a randomized controlled trial of varenicline in patients admitted to hospital. CMAJ : Canadian Medical Association Journal 2018;190(12):E347-54. - PMC - PubMed
Wong 2012 {unpublished data only}
    1. NCT00937508. Smoking cessation program in the pre-admission clinic.clinicaltrials.gov/ct2/show/NCT00937508 (first received 13 July 2009).
    1. Wong J, Abrishami A, Yang Y, Zaki A, Friedman Z, Selby P, et al. A perioperative smoking cessation intervention with varenicline: a double-blind, randomized, placebo-controlled trial. Anesthesiology 2012;117(4):755-64. [CENTRAL: 835869] [EMBASE: 2012567287] [PMID: ] - PubMed
Yang 2016 {published data only}
    1. Yang DX, Gu CJ, Ni L, Li N, Li QY, Zhou JP. Assessment of efficacy of medication combined with WeChat platform for quitting smoking in patients with chronic obstructive pulmonary disease. Journal of Shanghai Jiaotong University (Medical Science) 2016;36(3):385-9.
Zawertailo 2020 {published data only}
    1. NCT01286584. Varenicline in residential treatment (ViRT).clinicaltrials.gov/ct2/show/NCT01286584 (first received 31 January 2011).
    1. Zawertailo L, Ivanova A, Ng G, Le Foll B, Selby P. Safety and efficacy of varenicline for smoking cessation in alcohol-dependent smokers in concurrent treatment for alcohol use disorder: a pilot, randomized placebo-controlled trial. Journal of Clinical Psychopharmacology 2020;40(2):130-6. - PubMed
Zhang 2022 {published data only}
    1. NCT02146911. The MATCH (Medication Aids for Tobacco Cessation and Health) study.clinicaltrials.gov/show/NCT02146911 (first received 26 May 2014).
    1. Zawertailo L, Mansoursadeghi-Gilan T, Zhang H, Hussain S, Le Foll B, Selby P. Varenicline and bupropion for long-term smoking cessation (the MATCH Study): protocol for a real-world, pragmatic, randomized controlled trial. JMIR Research Protocols 2018;7(10):e10826. - PMC - PubMed
    1. Zhang H, Mansoursadeghi-Gilan T, Hussain S, Veldhuizen S, Le Foll B, Selby P, et al. Evaluating the effectiveness of bupropion and varenicline for smoking cessation using an internet-based delivery system: a pragmatic randomized controlled trial (MATCH study). Drug and Alcohol Dependence 2022;232:109312. - PubMed
Zincir 2013 {published data only}
    1. Zincir SB, Zincir S, Kaymak E, Sunbul EA. Comparison of the effectiveness of varenicline, extended-release bupropion and nicotine replacement therapy on the success and the maintenance of a smoking cessation program. Bulletin of Clinical Psychopharmacology 2013;23(3):224-30. [CENTRAL: 914104] [EMBASE: 2013628205]

References to studies excluded from this review

Brandon 2011 {published data only}
    1. Brandon TH, Drobes DJ, Unrod M, Heckman BW, Oliver JA, Roetzheim RC, et al. Varenicline effects on craving, cue reactivity, and smoking reward. Psychopharmacology 2011;218(2):391-403. - PMC - PubMed
Bullen 2018 {published data only}
    1. Bullen C, Verbiest M, Galea-Singer S, Kurdziel T, Laking G, Newcombe D, et al. The effectiveness and safety of combining varenicline with nicotine e-cigarettes for smoking cessation in people with mental illnesses and addictions: study protocol for a randomised-controlled trial. BMC Public Health 2018;18(1):596. - PMC - PubMed
Burstein 2006 {published data only}
    1. Burstein AH, Fullerton T, Clark DJ, Faessel HM. Pharmacokinetics, safety, and tolerability after single and multiple oral doses of varenicline in elderly smokers. Journal of Clinical Pharmacology 2006;46:1234-40. - PubMed
Chantix 2006 {published data only}
    1. Pfizer Inc. Chantix prescribing information.www.chantix.com/content/Prescribing_Information.jsp (accessed 10 February 2007).
Cui 2012 {published data only}
    1. Cui Q, Robinson L, Elston D, Smaill F, Cohen J, Quan C, et al. Safety and tolerability of varenicline tartrate (Champix®/Chantix®) for smoking cessation in HIV-infected subjects: a pilot open-label study. AIDS Patient Care and STDs 2012;26(1):12-19. [DOI: 10.1089/apc.2011.0199] - DOI - PMC - PubMed
Dezee 2013 {published data only}
    1. Cowan CM, Wink JS, DeZee KJ. Use of the patient health questionnaire-2 to predict suicidal ideations in patients taking varenicline. American Journal on Addictions / American Academy of Psychiatrists in Alcoholism and Addictions 2012;21(4):356-62. [PMID: ] - PubMed
    1. Dezee KJ, Wink JS, Cowan CM. Internet versus in-person counseling for patients taking varenicline for smoking cessation. Military Medicine 2013;178(4):401-5. [CENTRAL: 959429] [PMID: ] - PubMed
Dutra 2012 {published data only}
    1. Dutra SJ, Stoeckel LE, Carlini SV, Pizzagalli DA, Evins AE. Varenicline as a smoking cessation aid in schizophrenia: effects on smoking behavior and reward sensitivity. Psychopharmacology 2012;219(1):25-34. [DOI: 10.1007/s00213-011-2373-6] - DOI - PMC - PubMed
Ebbert 2009a {published data only}
    1. Ebbert JO, Croghan IT, Sood A, Schroeder DR, Hays JT, Hurt RD. Varenicline and bupropion sustained-release combination therapy for smoking cessation. Nicotine & Tobacco Research 2009;11(3):234-9. - PubMed
Ebbert 2009b {published data only}
    1. Ebbert JO, Burke MV, Hays JT, Hurt RD. Combination treatment with varenicline and nicotine replacement therapy. Nicotine & Tobacco Research 2009;11(5):572-6. - PubMed
Ebbert 2011b {published data only}
    1. Ebbert JO, Croghan IT, North F, Schroeder DR. A pilot study to assess smokeless tobacco use reduction with varenicline. Nicotine & Tobacco Research 2011;13(9):820-6. - PMC - PubMed
Ebbert 2014 {unpublished data only}
    1. Ebbert JO, Hatsukami DK, Croghan IT, Schroeder DR, Allen SS, Hays JT, et al. Combination varenicline and bupropion SR for tobacco-dependence treatment in cigarette smokers: a randomized trial. JAMA 2014;311(2):155-63. [CENTRAL: 921055] [EMBASE: 2014041620] [PMID: ] - PMC - PubMed
    1. NCT00935818. Varenicline and bupropion for smoking cessation (CHANBAN).clinicaltrials.gov/ct2/show/NCT00935818 (first received 9 July 2009).
Evins 2014 {published and unpublished data}
    1. Cather C, Hoeppner S, Pachas G, Pratt S, Achtyes E, Cieslak KM, et al. Improved depressive symptoms in adults with schizophrenia during a smoking cessation attempt with varenicline and behavioral therapy. Journal of Dual Diagnosis 2017;13(3):168-78. - PubMed
    1. Evins AE, Cather C, Pratt SA, Pachas GN, Hoeppner SS, Goff DC, et al. Maintenance treatment with varenicline for smoking cessation in patients with schizophrenia and bipolar disorder: a randomized clinical trial. JAMA 2014;311(2):145-54. [CENTRAL: 921056] [EMBASE: 2014041619] [PMID: ] - PMC - PubMed
    1. Evins AE. Extended duration pharmacotherapy with varenicline prevents relapse to smoking in adult smokers with schizophrenia. Neuropsychopharmacology 2013;38:S63-4. [CENTRAL: 993941] [EMBASE: 71278012]
    1. NCT00621777. A study of varenicline for prevention of relapse to smoking in patients with schizophrenia.clinicaltrials.gov/ct2/show/NCT00621777 (first received 22 February 2008).
    1. Pachas GN, Cather C, Pratt SI, Hoeppner B, Nino J, Carlini SV, et al. Varenicline for smoking cessation in schizophrenia: safety and effectiveness in a 12-week open-label trial. Journal of Dual Diagnosis 2012;8(2):117-25. - PMC - PubMed
Faessel 2009 {published data only}
    1. Faessel H, Ravva P, Williams K. Pharmacokinetics, safety, and tolerability of varenicline in healthy adolescent smokers: a multicenter, randomized, double-blind, placebo-controlled, parallel-group study. Clinical Therapeutics 2009;31:177-89. [clinicaltrials.gov ID: NCT00463918] - PubMed
Fagerström 2010 {published data only}
    1. Fagerström K, Gilljam H, Metcalfe M, Tonstad S, Messig M. Stopping smokeless tobacco with varenicline: randomised double blind placebo controlled trial. BMJ 2010;341:c6549. [DOI: 10.1136/bmjc6549] - DOI - PMC - PubMed
Falk 2014 {published data only}
    1. Falk DE, Litten RZ, Ryan ML, Fertig JB. A double-blind, placebo-controlled trial assessing the efficacy of varenicline tartrate for alcohol dependence. Alcoholism, Clinical and Experimental Research 2014;38 Suppl s1:139A. [CENTRAL: 993967] [EMBASE: 71503638]
    1. Litten RZ, Ryan ML, Fertig JB, Falk DE, Johnson B, Dunn KE, et al. A double-blind, placebo-controlled trial assessing the efficacy of varenicline tartrate for alcohol dependence. Journal of Addiction Medicine 2013;7(4):277-86. - PMC - PubMed
Fatemi 2013 {published data only}
    1. Fatemi SH, Yousefi MK, Kneeland RE, Liesch SB, Folsom TD, Thuras PD. Antismoking and potential antipsychotic effects of varenicline in subjects with schizophrenia or schizoaffective disorder: a double-blind placebo and bupropion-controlled study. Schizophrenia Research 2013;146(1-3):376-8. [CENTRAL: 877011] [PMID: ] - PubMed
    1. NCT01111149. Varenicline and smoking cessation in schizophrenia (VSCS).clinicaltrials.gov/ct2/show/NCT01111149 (first received 27 April 2010).
Ferketich 2012 {published data only}
    1. Ferketich AK, Otterson GA, King M, Hall N, Browning KK, Wewers ME. A pilot test of a combined tobacco dependence treatment and lung cancer screening program. Lung Cancer 2012;76(2):211-5. [CENTRAL: 814368] [EMBASE: 2012198269] [PMID: ] - PMC - PubMed
Ferketich 2013 {published data only}
    1. Ferketich AK, Diaz P, Browning KK, Lu B, Koletar SL, Reynolds NR, et al. Safety of varenicline among smokers enrolled in the lung HIV study. Nicotine & Tobacco Research 2013;15(1):247-54. [EMBASE: 2012756151] [PMID: ] - PMC - PubMed
Fertig 2015 {published data only}
    1. Fertig JB, Ryan ML, Falk DE, Litten RZ. Moderators of the varenicline treatment effect in a double-blind, placebo controlled trial for alcohol dependence. Alcoholism: Clinical and Experimental Research 2015;39:80A. - PMC - PubMed
Frye 2013 {published data only}
    1. Frye MA, Ebbert JO, Prince CA, Lineberry TW, Geske JR, Patten CA. A feasibility study of varenicline for smoking cessation in bipolar patients with subsyndromal depression. Journal of Clinical Psychopharmacology 2013;33(6):821-3. [PMID: ] - PubMed
Fucito 2011 {published data only}
    1. Fucito LM, Toll BA, Wu R, Romano DM, Tek C, O'Malley SS. A preliminary investigation of varenicline for heavy drinking smokers. Psychopharmacology 2011;215(4):655-63. - PMC - PubMed
Garza 2011 {published data only}
    1. Garza D, Murphy M, Tseng L-J, Riordan HJ, Chatterjee A. A double-blind randomized placebo-controlled pilot study of neuropsychiatric adverse events in abstinent smokers treated with varenicline or placebo. Biological Psychiatry 2011;69:1075-82. - PubMed
Granatowicz 1976 {published data only}
    1. Granatowicz J. Smoking cessation through the use of cytisine and other therapy. World Smoking Health 1976;1:8-11.
Gray 2012 {published data only}
    1. Gray KM, Carpenter MJ, Lewis AL, Klintworth EM, Upadhyaya HP. Varenicline versus bupropion XL for smoking cessation in older adolescents: a randomized, double-blind pilot trial. Nicotine & Tobacco Research 2012;14(2):235-9. [CENTRAL: 830824] [EMBASE: 2012065214] [PMID: ] - PMC - PubMed
Hajek 2011 {published data only}
    1. Dhelaria RK, Rothberg M. Is varenicline effectiveness declining in randomized trials? Archives of Internal Medicine 2011;171(19):1770-1. - PubMed
    1. Hajek P, McRobbie H, Myers K, Stapleton J, Dhanji AR. Is varenicline effectiveness declining in randomized trials? - Reply. Archives of Internal Medicine 2011;171(19):1771-2. - PubMed
    1. Hajek P, McRobbie HJ, Myers KE, Stapleton J, Dhanji A-R. Use of varenicline for 4 weeks before quitting smoking. Archives of Internal Medicine 2011;171(8):770-7. - PubMed
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Hajek 2013 {published data only}
    1. Hajek P, Smith KM, Dhanji A-R, McRobbie H. Is a combination of varenicline and nicotine patch more effective in helping smokers quit than varenicline alone? A randomised controlled trial. BMC Medicine 2013;11(1):140. [CENTRAL: 963647] [EMBASE: 2013375051] [PMID: ] - PMC - PubMed
Hajek 2015 {published data only}
    1. Hajek P, McRobbie H, Myers Smith K, Phillips A, Cornwall D, Dhanji AR. Erratum: increasing varenicline dose in smokers WHO do not respond to the standard dosage: a randomized clinical trial (JAMA internal medicine (2015) 175: 2 (266-271)). JAMA Internal Medicine 2016;176(1):143. - PubMed
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Hawk 2012 {published and unpublished data}
    1. Hawk LW, Ashare RL, Lohnes SF, Schlienz NJ, Rhodes JD, Tiffany ST, et al. The effects of extended pre-quit varenicline treatment on smoking behavior and short-term abstinence: a randomized clinical trial. Clinical Pharmacology and Therapeutics 2012;91(2):172-80. [CENTRAL: 814229] [PMID: ] - PMC - PubMed
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Hong 2011 {unpublished data only}
    1. Hong LE, Thaker GK, McMahon RP, Summerfelt A, Rachbeisel J, Fuller RL, et al. Effects of moderate-dose treatment with varenicline on neurobiological and cognitive biomarkers in smokers and nonsmokers with schizophrenia or schizoaffective disorder. Archives of General Psychiatry 2011;68(12):1195-206. [CENTRAL: 810278] [6348] [PMID: ] - PMC - PubMed
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Hoogsteder 2014 {published data only}
    1. Hoogsteder PH, Kotz D, Van Spiegel PI, Viechtbauer W, Van Schayck OC. Efficacy of the nicotine vaccine 3'-AmNic-rEPA (NicVAX) co-administered with varenicline and counselling for smoking cessation: a randomized placebo-controlled trial. Addiction 2014;109(8):1252-9. [CENTRAL: 1000793] [PMID: ] - PubMed
Hsueh 2014 {published data only}
    1. Hsueh K-C, Hsueh S-C, Chou M-Y, Pan L-F, Tu M-S, McEwen A, et al. Varenicline versus transdermal nicotine patch: a 3-year follow-up in a smoking cessation clinic in Taiwan. Psychopharmacology 2014;231(14):2819-23. [CENTRAL: 1050988] [EMBASE: 2014439532] [PMID: ] - PubMed
Hsueh 2021 {published data only}
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Hughes 2011 {published data only}
    1. Hughes JR, Rennard SI, Fingar JR, Talbot SK, Callas PW, Fagerström KO. Efficacy of varenicline to prompt quit attempts in smokers not currently trying to quit: a randomized placebo-controlled trial. Nicotine & Tobacco Research 2011;13(10):955-64. - PMC - PubMed
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IRCT20100127003210N {published data only}
    1. IRCT20100127003210N. Cytisine versus nicotine for smoking cessation in hospitalized psychiatric patients.http://www.who.int/trialsearch/Trial2.aspx?TrialID=IRCT20100127003210N16 (first received 2019).
Jain 2014 {published data only}
    1. Jain R, Jhanjee S, Jain V, Gupta T, Mittal S, Goelz P, et al. A double-blind placebo-controlled randomized trial of varenicline for smokeless tobacco dependence in India. Nicotine & Tobacco Research 2014;16(1):50-7. [CENTRAL: 1000326] [PMID: ] - PMC - PubMed
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Jiménez‐Ruiz 2013 {published data only}
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McClure 2013 {unpublished data only}
    1. McClure EA, Vandrey RG, Johnson MW, Stitzer ML. Effects of varenicline on abstinence and smoking reward following a programmed lapse. Nicotine & Tobacco Research 2013;15(1):139-48. [CENTRAL: 873078] [EMBASE: 2012756138] [PMID: ] - PMC - PubMed
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    1. McNaughton B, Frohlich J, Graham A, Young QR. Extended interactive voice response telephony (IVR) for relapse prevention after smoking cessation using varenicline and IVR: a pilot study. BMC Public Health 2013;13:824. [CENTRAL: 1015643] - PMC - PubMed
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Mocking 2013 {published data only}
    1. Mocking RJ, Patrick Pflanz C, Pringle A, Parsons E, McTavish SF, Cowen PJ, et al. Effects of short-term varenicline administration on emotional and cognitive processing in healthy, non-smoking adults: a randomized, double-blind, study. Neuropsychopharmacology 2013;38(3):476-84. - PMC - PubMed
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Nahvi 2014b {published data only}
    1. Nahvi S, Segal KS, Litwin AH, Arnsten JH. Rationale and design of a randomized controlled trial of varenicline directly observed therapy delivered in methadone clinics. Addiction Science & Clinical Practice 2014;9:9. [CENTRAL: 1037892] - PMC - PubMed
Nahvi 2020 {published data only}
    1. Nahvi S, Adams TR, Ning Y, Zhang C, Arnsten JH. Effect of varenicline directly observed therapy versus varenicline self-administered therapy on varenicline adherence and smoking cessation in methadone-maintained smokers: a randomized controlled trial. Addiction 2020;116(4):902-13. - PMC - PubMed
NCT00387946 {unpublished data only}
    1. NCT00387946. Efficacy and safety of dianicline treatment as an aid to smoking cessation in cigarette smokers (AMERIDIAN).clinicaltrials.gov/ct2/show/NCT00387946 (first received 13 October 2006).
NCT00502216 {unpublished data only}
    1. NCT00502216. Naltrexone and varenicline: weight gain and tolerability in smokers.ClinicalTrials.gov/show/NCT00502216 (first received 17 July 2007).
NCT00554840 {unpublished data only}
    1. NCT00554840. Comparison of varenicline and placebo for smoking cessation in schizophrenia.ClinicalTrials.gov/ct2/show/NCT00554840 (first received 7 November 2007).
NCT00828113 {unpublished data only}
    1. NCT00828113. Long-term varenicline treatment for smoking cessation.clinicaltrials.gov/ct2/show/NCT00828113 (first received 23 January 2009).
NCT01093937 {unpublished data only}
    1. NCT01093937. Study of varenicline for smoking cessation/reduction in patients with bipolar disorder.clinicaltrials.gov/ct2/show/NCT01093937 (first received 26 March 2010).
NCT01413516 {published data only}
    1. NCT01413516. A two-part pilot study of dosing, safety and efficacy of varenicline initiated during an acute smoke-free hospitalization and continued post-hospitalization.clinicaltrials.gov/show/NCT01413516 (first received 10 August 2011).
NCT01532232 {published data only}
    1. NCT01532232. Treatment of tobacco dependence in breast cancer patients: a randomized trial of varenicline (Chantix).ClinicalTrials.gov/show/NCT01532232 (first received 14 February 2012).
NCT01574703 {unpublished data only}
    1. NCT01574703. Study to evaluate cardiac assessments following different treatments of smoking cessation medications in subjects with and without psychiatric disorders [CATS].ClinicalTrials.gov/show/NCT01574703 (first received 10 April 2012).
NCT01592695 {published data only}
    1. NCT01592695. Tailored tobacco cessation program for rural veterans with comorbid depression, alcoholism or obesity.ClinicalTrials.gov/show/NCT01592695 (first received 7 May 2012).
NCT01639560 {unpublished data only}
    1. NCT01639560. Varenicline for light smokers (ChanLight).clinicaltrials.gov/ct2/show/NCT01639560 (first received 12 July 2012).
NCT01771627 {published data only}
    1. NCT01771627. Pilot study of varenicline vs. nicotine patch delivered by a telephone quitline to promote smoking cessation.ClinicalTrials.gov/show/NCT01771627 (first received 18 January 2013).
NCT01772641 {published data only}
    1. NCT01772641. A combination of scheduled reduced smoking with varenicline to enhance cessation.ClinicalTrials.gov/show/NCT01772641 (first received 21 January 2013).
NCT01806779 {unpublished data only}
    1. NCT01806779. Combination bupropion/varenicline for smoking cessation in male smokers.ClinicalTrials.gov/show/NCT01806779 (first received 7 March 2013).
NCT01892813 {published data only}
    1. NCT01892813. Tailored tobacco intervention.ClinicalTrials.gov/show/NCT01892813 (first received 4 July 2013).
NCT02048917 {published data only}
    1. NCT02048917. Optimization of smoking cessation strategies in community cancer programs for newly diagnosed lung and head and neck cancer patients.Clinicaltrials.gov/show/NCT02048917 (first received 29 January 2014). [CENTRAL: 1013511]
NCT02147132 {published data only}
    1. NCT02147132. A pilot randomized, placebo-controlled, crossover study of the effect of the nicotine nasal spray and varenicline on cigarette smoking following methadone dosing in methadone-maintained patients.ClinicalTrials.gov/show/NCT02147132 (first received 26 May 2014).
NCT02271919 {published data only}
    1. NCT02271919. Varenicline and combined nicotine replacement therapy (NRT) for initial smoking cessation and rescue Treatment in smokers: a randomized pilot trial.ClinicalTrials.gov/show/NCT02271919 (first received 22 October 2014).
NCT02501265 {published data only}
    1. NCT02501265. Adaptive pharmacotherapy for smoking cessation.https://clinicaltrials.gov/show/NCT02501265 (first received 17 July 2015).
NCT03709823 {published data only}
    1. NCT03709823. Trial of cytisine in adult smokers.clinicaltrials.gov/ct2/show/NCT03709823 (first received 17 October 2018).
Nides 2021 {published data only}
    1. Nides M, Rigotti NA, Benowitz N, Clarke A, Jacobs C. A multicenter, double-blind, randomized, placebo-controlled phase 2b trial of cytisinicline in adult smokers (the ORCA-1 trial). Nicotine & Tobacco Research 2021;23(10):1656-63. - PMC - PubMed
Nollen 2011 {published data only}
    1. Buchanan TS, Berg CJ, Cox LS, Nazir N, Benowitz NL, Yu L, et al. Adherence to varenicline among African American smokers: an exploratory analysis comparing plasma concentration, pill count, and self-report. Nicotine & Tobacco Research 2012;14(9):1083-91. [CENTRAL: 834603] [EMBASE: 2012554324] [PMID: ] - PMC - PubMed
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Patterson 2010 {unpublished data only}
    1. NCT00948649. Effects of Chantix on relapse prevention for smoking cessation.clinicaltrials.gov/ct2/show/NCT00948649 (first received 29 July 2009).
    1. Patterson F, Jepson C, Loughead J, Perkins K, Strasser AA, Siegel S, et al. Working memory deficits predict short-term smoking resumption following brief abstinence. Drug and Alcohol Dependence 2010;106(1):61-4. [CENTRAL: 731184] [PMID: ] - PMC - PubMed
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Paun 1968 {published data only}
    1. Paun D, Franze J. Smoking cessation with cytisine 'Tabex' tablets [Raucherentwöhnung mit cytisinhaltigen "Tabex" tabletten]. Sonderduck Aus Das Deutsche Gesundheitwesen 1968;23(44):2088-91. - PubMed
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Pfeifer 2019 {published data only}
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Pfizer 2006 {unpublished data only}
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    1. Rose JE, Behm FM. Combination treatment with varenicline and bupropion in an adaptive smoking cessation paradigm. American Journal of Psychiatry 2014;171(11):1199-205. [CENTRAL: 1021652] [EMBASE: 2014905509] [PMID: ] - PMC - PubMed
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Smith 2013 {unpublished data only}
    1. NCT00802919. Varenicline for cognitive deficits and cigarette smoking in schizophrenia.ClinicalTrials.gov/ct2/show/NCT00802919 (first received 5 December 2008).
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Stapleton 2008 {published data only}
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    1. Catz SL, Jack LM, McClure JB, Javitz HS, Deprey M, Zbikowski SM, et al. Adherence to varenicline in the COMPASS smoking cessation intervention trial. Nicotine & Tobacco Research 2011;13(5):361-8. - PMC - PubMed
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    1. Bolin K, Mörk A-C, Wilson K. Smoking-cessation therapy using varenicline: the cost-utility of an additional 12-week course of varenicline for the maintenance of smoking abstinence. Journal of Evaluation in Clinical Practice 2009;15:478-85. - PubMed
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Tønnesen 2013 {published and unpublished data}
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References to studies awaiting assessment

Wiratmoko 2013 {published data only}
    1. Wiratmoko MR, Yunus F, DSusanto A, Ginting TT, Kekalih A. Efficacy of varenicline, an nicotinic acetylcholine receptor partial agonist, vs placebo for smoking cessation. A randomized controlled trial. Respirology 2013;18 Suppl 4:66 [OS205]. [CENTRAL: 989836] [EMBASE: 71371580]
Yujie 2014 {published data only}
    1. Yujie W, Huliang L. Efficacy and safety of varenicline for smoking cessation in patients with CAD undergoing PCI. Journal of the American College of Cardiology 2014;64(16 Suppl 1):C207. [CENTRAL: 1054389] [EMBASE: 71665049]

References to ongoing studies

Berlin 2019 {published data only}
    1. Berlin I, Dautzenberg B, Lehmann B, Palmyre J, Liegey E, De Rycke Y, et al. Randomised, placebo-controlled, double-blind, double-dummy, multicentre trial comparing electronic cigarettes with nicotine to varenicline and to electronic cigarettes without nicotine: the ECSMOKE trial protocol. BMJ Open 2019;9(5):e028832. - PMC - PubMed
    1. NCT03630614. Randomized trial of electronic cigarettes with or without nicotine in smoking cessation.clinicaltrials.gov/ct2/show/NCT03630614 (first received 15 August 2018).
Caponnetto 2019 {published data only}
    1. Caponnetto P, Maglia M, Polosa R. Efficacy of smoking cessation with varenicline plus counselling for e-cigarettes users (VAREVAPE): a protocol for a randomized controlled trial. Contemporary Clinical Trials Communications 2019;15:100412. - PMC - PubMed
ChiCTR1900021400 {published data only}
    1. ChiCTR1900021400. Individual tobacco cessation research based on nicotine metabolite ratio in smoking patients with chronic obstructive pulmonary disease: a randomized controlled trial.www.who.int/trialsearch/Trial2.aspx?TrialID=ChiCTR1900021400 2019.
IRCT20200719048133N1 {published data only}
    1. IRCT20200719048133N1. Effect of varenicline in smoking cessation after invasive treatment of coronary artery disease.en.irct.ir/trial/49723 (first received 23 July 2020).
Lawson 2021 {published data only}
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Tindle 2020 {published data only}
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References to other published versions of this review

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