Mirtazapine for the Treatment of Methamphetamine Dependence Among MSM (M2.0)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Mirtazapine for the Treatment of Methamphetamine Dependence Among MSM: a 6-month Randomized Controlled Trial With 3 Months of Follow-up|
- Number of methamphetamine-positive urine tests [ Time Frame: weekly for 9 months ] [ Designated as safety issue: No ]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).
- Sexual risk (see description) [ Time Frame: 9 months ] [ Designated as safety issue: No ]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.
- Adherence to study drug [ Time Frame: 6 months ] [ Designated as safety issue: No ]To measure the acceptability of mirtazapine and placebo by determining (via electronic pill boxes and self-report) medication adherence including percent of doses taken, taking less than 80% of medication, patterns of non-adherence (e.g. use every other day, during the weekend, longer alternating periods on and off medication), and time to stopping medication.
- Number of adverse events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]To measure the tolerability of mirtazapine and placebo, as determined by the number of adverse clinical events in the mirtazapine and placebo arms.
|Study Start Date:||August 2013|
|Estimated Study Completion Date:||December 2017|
|Estimated Primary Completion Date:||December 2017 (Final data collection date for primary outcome measure)|
Active Comparator: Mirtazapine
mirtazapine 30 mg orally per day
Other Name: Remeron
Placebo Comparator: Placebo
placebo (30 mg) orally per day
Please refer to this study by its ClinicalTrials.gov identifier: NCT01888835
|Contact: Phillip O Coffin, M.D.||(415) firstname.lastname@example.org|
|Contact: Emily Behar, MSemail@example.com|
|United States, California|
|Substance Use Research Unit||Recruiting|
|San Francisco, California, United States, 94102|
|Contact: Phillip O Coffin, M.D. 415-437-6282 firstname.lastname@example.org|
|Contact: Deirdre M Santos, N.P. (415) 437-6227 email@example.com|
|Principal Investigator: Phillip O Coffin, M.D.|
|Principal Investigator: Steven L Batki, M.D.|
|Sub-Investigator: Eric Vittinghoff, PhD, MPH|
|Sub-Investigator: Glenn-Milo Santos, MPH, PhDc|
|Principal Investigator:||Phillip O Coffin, M.D.||San Francisco Department of Public Health|
|Principal Investigator:||Steven L Batki, M.D.||University of California, San Francisco|
|Study Director:||Emily Behar, MS||San Francisco Department of Public Health|