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Randomized Controlled Trial
. 2013 Apr;108(4):751-61.
doi: 10.1111/add.12073. Epub 2013 Jan 3.

Aripiprazole for the treatment of methamphetamine dependence: a randomized, double-blind, placebo-controlled trial

Phillip Oliver Coffin  1 , Glenn-Milo Santos, Moupali Das, Deirdre M Santos, Shannon Huffaker, Tim Matheson, James Gasper, Eric Vittinghoff, Grant N Colfax
Affiliations
Randomized Controlled Trial

Aripiprazole for the treatment of methamphetamine dependence: a randomized, double-blind, placebo-controlled trial

Phillip Oliver Coffin et al. Addiction. 2013 Apr.

Abstract

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.

Findings: Participant mean age was 38.7 years, 87.8% were male, 50.0% white, 18.9% African American, and 16.7% Latino. Eighty-three per cent of follow-up visits and final visits were completed. By intent-to-treat, participants assigned to aripiprazole had similar reductions in methamphetamine-positive urines as participants assigned to placebo [risk ratio (RR) 0.88, 95% confidence interval (CI): 0.66-1.19, P = 0.41]. Urine positivity declined from 73% (33 of 45 participants) to 45% (18 of 40) in the placebo arm and from 77% (34 of 44) to 44% (20 of 35) in the aripiprazole arm. Adherence by MEMS and self-report was 42 and 74%, respectively, with no significant difference between arms (MEMS P = 0.31; self-report P = 0.17). Most sexual risk behaviors declined similarly among participants in both arms (all P > 0.05). There were no serious adverse events related to study drug, although participants randomized to aripiprazole reported more akathisia, fatigue and drowsiness (P < 0.05).

Conclusion: Compared with placebo, aripiprazole did not reduce methamphetamine use significantly among actively using, dependent adults.

Trial registration: ClinicalTrials.gov NCT00497055.

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Conflict of interest statement

COMPETING INTERESTS

All authors declare that they have no competing interests.

Figures

Figure 1
Figure 1
Enrollment and Retention by treatment arm
Figure 2
Figure 2
Weekly Urine Positivity by treatment arm
Figure 3
Figure 3
Abstinence rates by week by treatment arm
See this image and copyright information in PMC

References

    1. United Nations Office on Drugs and Crime. World Drug Report 2012. UNODC; New York, United Nations: 2012.
    1. United States Substance Abuse and Mental Health Services Administration; Office of Applied Studies, SAMHSA. NSDUH Series. Rockville, MD: SAMHSA, Office of Applied Studies; 2010. Results from the 2009 National Survey on Drug Use and Health: Volume I. Summary of National Findings; pp. 13–28.
    1. Colfax G, Santos GM, Chu P, et al. Amphetamine-group substances and HIV. Lancet. 2010;376:458–74. - PubMed
    1. Semple SJ, Strathdee SA, Zians J, Patterson TL. Correlates of trading sex for methamphetamine in a sample of HIV-negative heterosexual methamphetamine users. Journal of psychoactive drugs. 2011;43:79–88. - PMC - PubMed
    1. Karila L, Weinstein A, Aubin HJ, et al. Pharmacological approaches to methamphetamine dependence: a focused review. Br J Clin Pharmacol. 2010;69:578–92. - PMC - PubMed

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