Mirtazapine to Reduce Methamphetamine Use Among MSM With High-risk HIV Behaviors
Condition: Substance Abuse; HIV Infections
MeSH terms: Substance-Related Disorders
Intervention: mirtazapine; placebo
Intervention description: mirtazapine 30 mg daily for 3 months; placebo 30 mg daily for 3 months
Intervention MeSH terms: Mirtazapine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 60.0
Sex: Male
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Methamphetamine; HIV; MSM; HIV Seronegativity

Summary:

      Studies demonstrate that methamphetamine (meth) use is associated with high-risk sexual
      behavior among MSM, putting meth-using MSM at extraordinarily high risk for transmitting or
      acquiring HIV. This study of intermediate size (60 participants) and length (3 months of
      follow-up) will assess the efficacy of mirtazapine in reducing methamphetamine use among
      high-risk MSM.
    

Eligibility criteria:

        Inclusion Criteria:

          1. HIV-negative by rapid test, or documentation of HIV infection with a laboratory result
             of a positive HIV test;

          2. male gender;

          3. reports having anal sex with men in the prior 3 months while using methamphetamine;

          4. diagnosed with methamphetamine dependence as determined by SCID;

          5. interested in stopping or reducing methamphetamine use;

          6. at least one methamphetamine-positive urine at screening and run-in period;

          7. no known allergies to mirtazapine;

          8. no current acute illnesses requiring prolonged medical care;

          9. no chronic illnesses that are likely to progress clinically during trial
             participation;

         10. able and willing to provide informed consent and to be followed over a 3-month period;

         11. age 18-60 years;

         12. baseline CBC, total protein, albumin, glucose, alk phos, creatinine, BUN and
             electrolytes without clinically significant abnormalities as determined by
             investigator in conjunction with symptoms, physical exam, and medical history.

        Exclusion Criteria:

          1. evidence of current major depression, as determined by SCID;70

          2. history of bipolar disorder or psychosis, as determined by SCID;

          3. taking anti-depressant or other psychotropic medication within the last 30 days,
             including mirtazapine or a monoamine oxidase (MAO) inhibitor;

          4. currently using or unwilling not to use pseudoephedrine-containing products for trial
             duration (causes false positive urines for methamphetamine use);

          5. current CD4 count < 200 cells/mm3;

          6. measured moderate or severe liver disease (AST, ALT, and total bilirubin > 3 times
             upper limit of normal) and/or any symptoms of current liver disease;

          7. impaired renal function (creatinine clearance < 60 ml/min);

          8. currently participating in another research study;

          9. any condition that, in the principal investigator's judgment, interferes with safe
             study participation or adherence to study procedures.