Clinical Trial: Mirtazapine for the Treatment of Methamphetamine Dependence Among MSM (M2.0)

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Mirtazapine for the Treatment of Methamphetamine Dependence Among MSM: a 6-month Randomized Controlled Trial With 3 Months of Follow-up

Brief Summary: The investigators recently conducted a double-blind, randomized controlled trial (n=60) of limited duration (12 weeks), and found that compared with placebo, oral mirtazapine, an FDA-approved antidepressant, significantly reduced meth use in those receiving mirtazapine, as determined by reduction in meth-positive urines. Sexual risk behaviors also declined significantly in the mirtazapine arm compared to placebo. Mirtazapine decreased meth use despite low adherence: by medical event monitoring system (MEMS) caps, only 48.5% of daily doses were taken. All participants received weekly substance use counseling and monthly, brief clinician-delivered adherence counseling. The investigators propose expanding upon these results by lengthening the treatment period to 24 weeks, with adherence reminders added to the counseling, and determining if efficacy is sustained up to 12 weeks after drug discontinuation. The sample size for this 9-month study is 120.

Detailed Summary:
Sponsor: Phillip Coffin, MD, MIA

Current Primary Outcome: Number of methamphetamine-positive urine tests [ Time Frame: weekly for 9 months ]

To determine the efficacy of mirtazapine vs placebo at 12 weeks and 24 weeks of treatment plus counseling, and to determine whether efficacy is sustained for an additional 12 weeks after discontinuation of treatment and counseling (weeks 24 to 36).


Original Primary Outcome: Same as current

Current Secondary Outcome: Sexual risk (see description) [ Time Frame: 9 months ]

To assess if the intervention reduces HIV risk behaviors, including number of male sex partners, number of male anal sex partners with whom meth is used and episodes of unprotected anal sex with serodiscordant partners.


Original Secondary Outcome: Same as current

Information By: San Francisco Department of Public Health

Dates:
Date Received: June 25, 2013
Date Started: August 2013
Date Completion: December 2017
Last Updated: September 28, 2016
Last Verified: September 2016