At a glance
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Bupropion-Enhanced CM for Cocaine Dependence
In Brief
A Phase 3 clinical trial evaluating Placebo, Bupropion XL, and 2 other interventions for Substance Abuse and Cocaine Dependence. Completed, enrolled 83 participants across 2 sites.
Detailed Summary
This project will examine effects of bupropion extended release (XL) at a dose of 300mg/day for cocaine abstinence among persons receiving methadone for the treatment of opioid use disorder. Participants also earned financial incentives for providing urine samples that tested negative for cocaine. Bupropion was examined for this purpose because of its previously demonstrated efficacy and safety as well as its pharmacological actions at dopamine systems. Participants were randomly assigned to bupropion XL vs. placebo and received different incentive schedules depending on whether they demonstrated abstinence from cocaine early in the study. Outcomes were tracked over a 6-month time frame and the overarching hypothesis was that bupropion (as compared to placebo) would increase the number of urine samples testing negative for cocaine, independent of whether participants demonstrated abstinence from cocaine early in the study.
Study Details
Timeline
Interventions
Participants will be randomly assigned to receive placebo powder in twice-daily capsules at the end of week 2.
Participants will be randomly assigned to receive bupropion XL 150mg/day in twice-daily capsules at the end of week 2.
Participants will provide urine samples thrice weekly during weeks 1-6 of the study. Urine samples will be tested immediately onsite for evidence of recent cocaine exposure. Participants who do not provide 3 urine samples that test negative for cocaine by the end of week 6 will be assigned to an Abstinence Incentive condition.
Participants will provide urine samples thrice weekly during weeks 1-6 of the study. Urine samples will be tested immediately onsite for evidence of recent cocaine exposure. Participants who provide 3 urine samples that test negative for cocaine will be promptly assigned to a Relapse Prevention incentive condition.