Mirtazapine for the Treatment of Methamphetamine Dependence Among MSM (M2.0) (NCT01888835) | Clinical Trial Compass
CompletedPhase 2
Mirtazapine for the Treatment of Methamphetamine Dependence Among MSM (M2.0)
United States120 participantsStarted 2013-08
Plain-language 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.
Who can participate
Age range18 Years – 69 Years
SexMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. born male, or born female and does not identify as female;
✓. reports anal sex with men in the prior three months while under the influence of meth;
✓. diagnosed with meth dependence by SCID;
✓. interested in stopping or reducing meth use;
✓. at least one meth-positive urine during screening and run-in period;
✓. no current acute illness requiring prolonged medical care;
✓. no serious chronic illnesses that are likely to progress clinically during trial participation;
✓. able and willing to provide informed consent and adhere to visit schedule;
Exclusion criteria
✕. Evidence of current major depression by SCID;
✕. history of bipolar disorder or psychotic disorder, as determined by SCID;