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 ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Sexual risk (see description) [ Time Frame: 9 months ]
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