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Randomized Controlled Trial
. 2011 Nov;68(11):1168-75.
doi: 10.1001/archgenpsychiatry.2011.124.

Mirtazapine to reduce methamphetamine use: a randomized controlled trial

Grant N Colfax  1 , Glenn-Milo Santos, Moupali Das, Deirdre McDermott Santos, Tim Matheson, James Gasper, Steve Shoptaw, Eric Vittinghoff
Affiliations
Randomized Controlled Trial

Mirtazapine to reduce methamphetamine use: a randomized controlled trial

Grant N Colfax et al. Arch Gen Psychiatry. 2011 Nov.

Abstract

Context: No approved pharmacologic treatments for methamphetamine dependence exist. Methamphetamine use is associated with high morbidity and is a major cofactor in the human immunodeficiency virus epidemic among men who have sex with men (MSM).

Objective: To determine whether mirtazapine would reduce methamphetamine use among MSM who are actively using methamphetamine.

Design: Double-blind, randomized, controlled, 12-week trial of mirtazapine vs placebo conducted from September 5, 2007, to March 4, 2010.

Setting: San Francisco Department of Public Health.

Participants: Participants were actively using, methamphetamine-dependent, sexually active MSM seen weekly for urine sample collection and substance use counseling.

Interventions: Random assignment to daily oral mirtazapine (30 mg) or placebo; both arms included 30-minute weekly substance use counseling.

Main outcome measures: The primary study outcome was reduction in methamphetamine-positive urine test results. Secondary outcomes were study medication adherence (by self-report and medication event monitoring systems) and sexual risk behavior.

Results: Sixty MSM were randomized, 85% of follow-up visits were completed, and 56 participants (93%) completed the final visit. In the primary intent-to-treat analysis, participants assigned to the mirtazapine group had fewer methamphetamine-positive urine test results compared with participants assigned to the placebo group (relative risk, 0.57; 95% CI, 0.35-0.93, P = .02). Urine positivity decreased from 67% (20 of 30 participants) to 63% (17 of 27) in the placebo arm and from 73% (22 of 30) to 44% (12 of 27) in the mirtazapine arm. The number needed to treat to achieve a negative weekly urine test result was 3.1. Adherence was 48.5% by medication event monitoring systems and 74.7% by self-report; adherence measures were not significantly different between arms (medication event monitoring systems, P = .82; self-report, P = .92). Most sexual risk behaviors decreased significantly more among participants taking mirtazapine compared with those taking placebo (number of male partners with whom methamphetamine was used, P = .009; number of male partners, P = .04; episodes of anal sex with serodiscordant partners, P = .003; episodes of unprotected anal sex with serodiscordant partners, P = .003; episodes of insertive anal sex with serodiscordant partners, P = .001). There were no serious adverse events related to study drug or significant differences in adverse events by arm (P ≥ .99).

Conclusion: The addition of mirtazapine to substance use counseling decreased methamphetamine use among active users and was associated with decreases in sexual risk despite low to moderate medication adherence. Trial Registration clinicalTrials.gov Identifier NCT00497081.

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Figures

Figure 1
Figure 1
Screening, randomization, and follow-up of study participants.
Figure 2
Figure 2
Observed and fitted weekly urinalysis results, according to treatment arm. Fitted trend lines are based on the primary outcome model.
See this image and copyright information in PMC

References

    1. United Nations Office on Drugs and Crime. World Drug Report 2009. New York, NY: United Nations; 2009.
    1. Substance Abuse and Mental Health Services Administration. Summary of National Findings. Vol. I. Rockville, MD: Substance Abuse and Mental Health Services Administration, Office of Applied Studies; 2010. Results from the 2009 National Survey on Drug Use and Health.
    1. Colfax G, Santos G-M, Chu P, Vittinghoff E, Pluddemann A, Kumar S, Hart C. Amphetamine-group substances and HIV. Lancet. 2010;376(9739):458–474. - PubMed
    1. Purcell DW, Johnson C, Lansky A, Prejean J, Stein R, Denning P, Gaul Z, Wein-stock H, Su J, Crepaz N. Calculating HIV and syphilis rates for risk groups: estimating the national population size of men who have sex with men. Paper presented at: National STD Prevention Conference; March 10, 2010; Atlanta, Georgia.
    1. Sanchez T, Finlayson T, Drake A, Behel S, Cribbin M, Dinenno E, Hall T, Kramer S, Lansky A Centers for Disease Control and Prevention (CDC) Human immunodeficiency virus (HIV) risk, prevention, and testing behaviors—United States, National HIV Behavioral Surveillance System: men who have sex with men, November 2003–April 2005 [published correction appears in MMWR Surveill Summ.2006;55(27):752] MMWR Surveill Summ. 2006;55(27):1–16. - PubMed

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