Mirtazapine for the Treatment of Methamphetamine Dependence Among MSM (M2.0)
|ClinicalTrials.gov Identifier: NCT01888835|
Recruitment Status : Active, not recruiting
First Posted : June 28, 2013
Last Update Posted : September 25, 2017
|Condition or disease||Intervention/treatment||Phase|
|Amphetamine-Related Disorders||Drug: Mirtazapine Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Mirtazapine for the Treatment of Methamphetamine Dependence Among MSM: a 6-month Randomized Controlled Trial With 3 Months of Follow-up|
|Study Start Date :||August 2013|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2017|
Active Comparator: Mirtazapine
mirtazapine 30 mg orally per day
Other Name: Remeron
Placebo Comparator: Placebo
placebo (30 mg) orally per day
- 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).
- 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.
- Adherence to study drug [ Time Frame: 6 months ]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 ]To measure the tolerability of mirtazapine and placebo, as determined by the number of adverse clinical events in the mirtazapine and placebo arms.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01888835
|United States, California|
|Substance Use Research Unit|
|San Francisco, California, United States, 94102|
|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:||Jaclyn Hern, MPH||San Francisco Department of Public Health|