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

Completed · Phase 2 · Has a placebo group

Conditions studied: Amphetamine-Related Disorders

In brief

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.

Key facts

Study ID

NCT01888835

Run by

Phillip Coffin, MD, MIA

People needed

120

Starts

2013-08-01

Expected to finish

2017-10-01

Last updated by the study team

2018-03-13

Who can join

Age: 18 and older, up to 69. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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;
• age 18-69 years;
• baseline CBC, total protein, albumin, glucose, alkaline phosphatase, creatinine, BUN, and electrolytes without clinically significant abnormalities as determined by clinician in conjunction with symptoms, physical exam, and medical history
• current CD4 count ≥ 200 cells/mm3; or CD4 count of 100 - 199 cells/mm3 and HIV viral load < 200 copies/mL
• text-capable cell phone or access to email

You may not qualify if…

• Evidence of current major depression by SCID;
• history of bipolar disorder or psychotic disorder, as determined by SCID;
• known allergy or previous adverse reaction to mirtazapine;
• taking an anti-depressant medication within the past 30 days, including mirtazapine or a monoamineoxidase inhibitor;
• moderate or severe liver disease (AST, ALT, and total bilirubin >= 5 times upper limit of normal);
• impaired renal function (estimated GFR <40 ml/min);
• currently participating in another research study;
• pending legal proceedings with high risk for incarceration during the time of planned study participation;
• any condition that, in the principal investigator's judgment, interferes with safe study participation or adherence to study procedures.

Where it is running

• Substance Use Research Unit — San Francisco, California, United States

Full record on ClinicalTrials.gov

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