Aripiprazole Treatment for Methamphetamine Dependence Among High-risk Individuals

Phase 2 Completed 90 enrolled San Francisco Department of Public Health National Institute on Drug Abuse (NIDA) · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

Studies demonstrate that methamphetamine (meth) use is associated with high-risk sexual behavior among men who have sex with men (MSM), putting meth-using MSM at extraordinarily high risk for transmitting or acquiring HIV. This study is a randomized, double-blind, placebo-controlled trial of the medication aripiprazole for methamphetamine-using individuals, including MSM, and will assess efficacy, acceptability, tolerability, safety, and adherence to study medication.

Timeline

Start: 2009-03
Primary completion: 2012-03
Completion: 2012-03

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Aripiprazole vs Placebo; p = .41; Risk Ratio (RR) .88 (95% CI .66 to 1.16); Generalized estimating equation NCT00497055 ↗

paper Compared with placebo, aripiprazole did not reduce methamphetamine use significantly among actively using, dependent adults. PMID 23186131 ↗

Publications

Results Coffin PO, Santos GM, Das M, Santos DM, Huffaker S, Matheson T, Gasper J, Vittinghoff E, Colfax GN. Aripiprazole for the treatment of methamphetamine dependence: a randomized, double-blind, placebo-controlled trial. Addiction. 2013 Apr;108(4):751-61. doi: 10.1111/add.12073. Epub 2013 Jan 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Aripiprazole	Other / unclassified	20 mg	—