Despite a lack of evidence that needle exchange programs (NEPs) cause an increase in injection drug use, there are still concerns over fostering increased injection behavior with NEPs. The design was a randomized controlled trial conducted from May 1997 to June 2000 comparing injection drug users (IDUs) who are randomly assigned to have access to an NEP versus training in how to purchase needles and syringes (NS) at pharmacies. Of 653 IDUs recruited into the study, 600 were randomized: 426 were followed-up at 6 months, and 369 were followed-up at 12 months. Four hundred ninety were followed up at least once. There was no difference in the number of injections over time between the NEP and the Pharmacy Sales arms of the study or in the percentage of positive urine test results over time between the NEP and the Pharmacy Sales arms of the study for morphine and amphetamine. The decrease in the presence of cocaine was marginally greater between the arms of the study. The results do not support the hypothesis of NEPs causing an increase in injection drug use. This clinical trial provides the strongest evidence to date that needle exchanges do not produce this negative effect.

• R01 DA 10181/DA/NIDA NIH HHS/United States