- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00497081
Mirtazapine to Reduce Methamphetamine Use Among MSM With High-risk HIV Behaviors
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Methamphetamine use is especially prevalent among men who have sex with men (MSM). Population-based surveys report methamphetamine use rates 20 times higher among MSM compared with the general population. Methamphetamine use is also a driving force in the MSM HIV epidemic: methamphetamine use has been associated with increased number of sexual partners, unprotected sex acts, and sexually transmitted infection (STI) and HIV acquisition. Despite these alarming data, relatively few interventions have been tested among methamphetamine-using MSM, and no studies have tested the efficacy of pharmacologic interventions in reducing methamphetamine use in this population. In parallel with the continued testing of behavioral approaches, we believe the time has come to test pharmacologic interventions to reduce methamphetamine use among MSM. Pharmacologic approaches to treating substance use have been successful in treating nicotine, alcohol, and heroin dependence. No studies have tested a pharmacologic intervention to reduce methamphetamine use among MSM at high risk for HIV acquisition and transmission. A recent pilot study found that mirtazapine, a drug with dual dopaminergic and serotonergic properties, significantly reduced methamphetamine withdrawal symptoms when compared to placebo over a two-week period among Thai men in a drug probation center. Mirtazapine is a commonly used, FDA-approved antidepressant; however, in the Thai study its effects on methamphetamine withdrawal were independent of its effects on depressive symptoms, suggesting a direct effect of mirtazapine on treating methamphetamine dependence. We propose to expand upon these promising pilot results by conducting a study of intermediate size (60 participants) and length (3 months of follow-up) to assess the efficacy of mirtazapine in reducing methamphetamine use among high-risk MSM.
The specific aims of our study are:
- To test the hypothesis that mirtazapine 30 mg daily will reduce methamphetamine use significantly more than placebo among methamphetamine-dependent MSM, as determined by the proportion of methamphetamine-negative urines and by self-report of methamphetamine use in the mirtazapine versus placebo group.
- To measure the acceptability of mirtazapine and placebo among methamphetamine-dependent MSM, by determining (via electronic pill caps and self-report) medication adherence to mirtazapine and placebo.
- To measure the safety and tolerability of mirtazapine and placebo among methamphetamine-dependent MSM, as determined by the number of adverse clinical events in the mirtazapine and placebo arms.
If promising, study results will be used to design a phase III clinical trial to determine if mirtazapine's effects on reducing methamphetamine use lead to reductions in methamphetamine-associated sexual risk. We have chosen first to conduct a 3-year intermediate-sized trial in order to determine if mirtazapine reduces methamphetamine use and whether mirtazapine demonstrates good acceptability and tolerability among a population with methamphetamine-associated high-risk sexual behaviors. If this proves to be the case, we believe our study results will provide strong support for a much larger trial to test the hypothesis that mirtazapine-driven reductions in methamphetamine use will result in corresponding decreases in sexual risk behavior. This study is therefore designed to reflect the structure of a larger HIV-risk reduction trial and includes both substance use and sexual risk behavior measures. We will enroll sexually active, methamphetamine-dependent MSM (either HIV-negative or HIV-positive) who will be randomized 1:1 to receive mirtazapine or placebo for 90 days. Because no medications have been approved to treat methamphetamine dependence, we include extensive safety parameters, as is required by the Food and Drug Administration (FDA) when testing a medication for a new indication in a new population. Participants will be seen weekly for urine drug testing and for brief substance use counseling. All will receive HIV risk-reduction counseling. Behavior will be assessed using standardized measures via audio computer-assisted self-interview (ACASI).
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
California
-
San Francisco, California, United States, 94102
- San Francisco Department of Public Health, Substance Use Research Unit
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 < 200 cells/mm3;
- 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;
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Mirtazapine
mirtazapine 30 mg daily
|
mirtazapine 30 mg daily for 3 months
Other Names:
|
PLACEBO_COMPARATOR: Placebo
placebo 30 mg daily
|
placebo 30 mg daily for 3 months
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Number of Positive Methamphetamine Urine Tests, Comparing Baseline (Week 0) to Final Visit (Week 12).
Time Frame: Baseline (week 0) and Final Visit (week 12)
|
Baseline (week 0) and Final Visit (week 12)
|
|
Proportion of Days With Recorded Pill Bottle Opening, as Determined by MEMS.
Time Frame: Daily, from Baseline (week 0) through Final Visit (week 12)
|
Proportion of days with recorded pill bottle opening, as determined by MEMS (medication event monitoring system).
|
Daily, from Baseline (week 0) through Final Visit (week 12)
|
Frequency of Adverse Events Reported
Time Frame: From Baseline (week 0) through Final Visit (week 12)
|
From Baseline (week 0) through Final Visit (week 12)
|
Collaborators and Investigators
Investigators
- Principal Investigator: Grant N Colfax, MD, Co-Directior, HIV Epidemiology Section, San Francisco Department of Public Health
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Substance-Related Disorders
- Physiological Effects of Drugs
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Agents
- Antidepressive Agents
- Serotonin 5-HT2 Receptor Antagonists
- Serotonin Antagonists
- Anti-Anxiety Agents
- Serotonin 5-HT3 Receptor Antagonists
- Histamine H1 Antagonists
- Histamine Antagonists
- Histamine Agents
- Adrenergic alpha-Antagonists
- Adrenergic alpha-2 Receptor Antagonists
- Mirtazapine
Other Study ID Numbers
- 1R01DA022155-01 (NIH)
- DPMC (Other Identifier: NIDA)
- R01DA022155 (NIH)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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