Phase 2
N=60
Mirtazapine to Reduce Methamphetamine Use Among MSM With High-risk HIV Behaviors
Substance Abuse · HIV Infections
Bottom Line
View on ClinicalTrials.gov: NCT00497081 ↗Enrolled (actual)
60
Serious AEs
3.3%
Results posted
Oct 2014
Primary outcome: Primary: Change in Number of Positive Methamphetamine Urine Tests, Comparing Baseline (Week 0) to Final Visit (Week 12). — 40; 6 Percentage reduction
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- mirtazapine (Drug); placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Male
- Sponsor
- San Francisco Department of Public Health
- Primary completion
- Mar 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Number of Positive Methamphetamine Urine Tests, Comparing Baseline (Week 0) to Final Visit (Week 12). |
40; 6 | — |
| PRIMARY Proportion of Days With Recorded Pill Bottle Opening, as Determined by MEMS. |
48.3; 48.7 | — |
| PRIMARY Frequency of Adverse Events Reported |
109; 107 | — |
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
- HIV-negative by rapid test, or documentation of HIV infection with a laboratory result of a positive HIV test;
- male gender;
- reports having anal sex with men in the prior 3 months while using methamphetamine;
- diagnosed with methamphetamine dependence as determined by SCID;
- interested in stopping or reducing methamphetamine use;
- at least one methamphetamine-positive urine at screening and run-in period;
- no known allergies to mirtazapine;
- no current acute illnesses requiring prolonged medical care;
- no chronic illnesses that are likely to progress clinically during trial participation;
- able and willing to provide informed consent and to be followed over a 3-month period;
- age 18-60 years;
- 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
- evidence of current major depression, as determined by SCID;70
- history of bipolar disorder or psychosis, as determined by SCID;
- taking anti-depressant or other psychotropic medication within the last 30 days, including mirtazapine or a monoamine oxidase (MAO) inhibitor;
- currently using or unwilling not to use pseudoephedrine-containing products for trial duration (causes false positive urines for methamphetamine use);
- current CD4 count 3 times upper limit of normal) and/or any symptoms of current liver disease;
- impaired renal function (creatinine clearance < 60 ml/min);
- currently participating in another research study;
- any condition that, in the principal investigator's judgment, interferes with safe study participation or adherence to study procedures.
Data sourced from ClinicalTrials.gov (NCT00497081). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.