Aims-To test aripiprazole for efficacy in decreasing use in methamphetamine-dependent adults, compared to placebo.Design-Participants were randomized to receive 12 weeks of aripiprazole or placebo, with a 3 month follow-up and a platform of weekly 30-minute substance abuse counseling.
Setting-The trial was conducted from January 2009 to March 2012 at the San Francisco Department of Public Health.Participants-Ninety actively-using, methamphetamine-dependent, sexually active, adults were recruited from community venues.Measurements-The primary outcome was regression estimated reductions in weekly methamphetamine-positive urines. Secondary outcomes were study medication adherence (by self-report and medication event monitoring systems [MEMS]), sexual risk behavior, and abstinence from methamphetamine.
COMPETING INTERESTSAll authors declare that they have no competing interests.
AUTHORS' CONTRIBUTIONSPC directed study activities, participated in the interpretation of data, and drafted the manuscript. GS participated in study design, performed the statistical analysis and interpretation of data, and participated in drafting of the manuscript. MD participated in study design and coordination, and interpretation of data. DS coordinated the study, participated in study design, acquisition and interpretation of data, and participated in study activities. SH participated in the acquisition and interpretation of data. TM participated in study design and in study activities. JG participated in the design of the study. EV participated in the design of the study and the statistical analysis and interpretation of data. GC conceived and designed the study and participated in the conduct of the study and interpretation of data. All authors participated in the revision of the manuscript for important intellectual content and provided approval of the final version of the manuscript.
Declarations of interest:The study was funded by a National Institute on Drug Abuse grant, 1 R01 DA023387-01. The funder did not play any role in study design; in the collection, analysis, and interpretation of data; in the writing of the report; nor in the preparation, review, or approval of the manuscript. Conclusion-Compared with placebo, aripiprazole did not significantly reduce methamphetamine use among actively-using, dependent adults.
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