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

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;
• 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

Exclusion criteria

• 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.