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Randomized Controlled Trial
.2019 May;43(5):937-944.
doi: 10.1111/acer.13994. Epub 2019 Mar 21.

Longitudinal Findings from a Randomized Clinical Trial of Varenicline for Alcohol Use Disorder with Comorbid Cigarette Smoking

Affiliations
Randomized Controlled Trial

Longitudinal Findings from a Randomized Clinical Trial of Varenicline for Alcohol Use Disorder with Comorbid Cigarette Smoking

Krysten W Bold et al. Alcohol Clin Exp Res.2019 May.

Abstract

Background: This study is the first to examine longitudinal posttreatment outcomes of a placebo-controlled trial of varenicline for alcohol use disorder (AUD) with comorbid cigarette smoking.

Methods: Participants were 131 adults (n = 39 female) seeking alcohol treatment in a randomized, double-blind, parallel group, placebo-controlled, 16-week multisite trial of varenicline combined with medical management (MM). Timeline follow-back assessments of alcohol and smoking behavior were conducted at the end of treatment (4 months), with follow-ups at 6, 9, and 12 months. Outcomes were percentage of heavy drinking days (PHDD), percent of participants with no heavy drinking days (NHDD), cotinine-confirmed prolonged smoking abstinence (PA), and good clinical outcome on either NHDD or PA.

Results: Treatment improvements were maintained posttreatment. For the sample overall, PHDD or NHDD did not differ significantly by treatment condition (ps > 0.13), but varenicline produced higher rates of PA versus placebo at 4, 9, and 12 months (p < 0.05). Significant differences were observed by sex: Males had higher rates of NHDD with varenicline (28.9%) versus placebo (6.4%) at the end of treatment (p = 0.004), and these effects were maintained at 12 months (varenicline: 40.0% vs. placebo: 19.2%, p = 0.03). Higher rates of PA were seen for varenicline in both males (8.9%) and females (21.1%) versus placebo (males/females: 0%) at the end of treatment (p = 0.05), and this effect was maintained at 12 months for females (varenicline: 21.1% vs. placebo, 0.0%, p = 0.05).

Conclusions: Varenicline treatment combined with MM appears to have enduring benefits for patients with co-occurring AUD and cigarette smoking, and these effects may differ by sex.

Trial registration: ClinicalTrials.govNCT01553136.

Keywords: Alcohol; Smoking; Tobacco; Treatment; Varenicline.

© 2019 by the Research Society on Alcoholism.

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Conflict of interest statement

Conflict of Interest/Disclosures: Dr. O’Malley reported having been a consultant or an advisory board member for Alkermes, Amygdala, Arkeo, Cerecor, Mitsubishi Tanabe, Opiant, Pfizer; honoraria from the American Society of Clinical Psychopharmacology Alcohol Clinical Trials Initiative supported by Abbott, Amygdala, Ethylpharm, Lilly, Lundbeck, Otsuka, Pfizer, Arbor Pharmaceuticals, and Indivior and from the Emmes Corporation as a DSMB member for the NIDA Clinical Trials Network; a coinvestigator on studies receiving donated medications from Astra Zeneca, Norvatis; a contract from Lilly; and a scientific panel member for Hazelden Foundation. Dr. Gueorguieva discloses consulting fees for Palo Alto Health Sciences, Knopp Biosciences and Mathematica Policy Research, royalties from book “Statistical Methods in Psychiatry and Related Fields” published by CRC Press, honorarium from the American Society of Clinical Psychopharmacology’s Alcohol Clinical Trials Initiative, and a provisional patent submission by Yale University: Chekroud, AM., Gueorguieva, R., & Krystal, JH. “Treatment Selection for Major Depressive Disorder” [filing date 3rd June 2016, USPTO docket number Y0087.70116US00]. No other disclosures were reported.

Figures

Figure 1:
Figure 1:
Study Follow-up Flow Diagram by Treatment Condition. Note: NHDD=percent of participants with no heavy drinking days, PA=prolonged smoking abstinence, GCO=good clinical outcome (either NHDD or PA), PHDD=percentage of heavy drinking days. Missing data on binary outcomes (NHDD, PA, GCO) are treated as failed.
Figure 2:
Figure 2:
Least Square Means of Log-transformed Percentage of Heavy Drinking Days (PHDD) by Medication, Time, and Sex. Note: PHDD calculated during the last 8 weeks at each time point. Month 4 corresponds to the end of treatment and medication discontinuation.
Figure 3:
Figure 3:
Percent of Participants with No Heavy Drinking Days (NHDD) by Medication, Time, and Sex. Note: NHDD calculated during the last 8 weeks at each time point with missing data treated as failed. Month 4 corresponds to the end of treatment and medication discontinuation. **p≤.01, *p≤.05.
Figure 4:
Figure 4:
Percent of Participants with Prolonged Smoking Abstinence (PA) by Medication, Time, and Sex. Note: PA, defined as self-reported smoking abstinence in the last 4 weeks at each time point, confirmed by plasma cotinine levels< 6 ng/mL with missing data treated as smoking. Month 4 corresponds to the end of treatment and medication discontinuation. *p≤.05.
Figure 5:
Figure 5:
Percent of Participants with Good Clinical Outcome on Either Alcohol (NHDD) or Smoking (SA) by Medication, Time, and Sex. Note: Good clinical outcome (GCO) defined as achieving positive outcomes on either alcohol (NHDD) or smoking (PA) during the last 4 weeks at each time point with missing data treated as failed. Month 4 corresponds to the end of treatment and medication discontinuation. **p≤.01; +p=.06
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