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Mirtazapine to Reduce Methamphetamine Use Among MSM With High-risk HIV Behaviors

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ClinicalTrials.gov Identifier: NCT00497081
Recruitment Status : Completed
First Posted : July 6, 2007
Results First Posted : October 20, 2014
Last Update Posted : January 5, 2015
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Substance Abuse HIV Infections Drug: mirtazapine Drug: placebo Phase 2

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:

  1. 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.
  2. 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.
  3. 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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Mirtazapine to Reduce Methamphetamine Use Among MSM With High-risk HIV Behaviors
Study Start Date : May 2007
Primary Completion Date : March 2010
Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Mirtazapine
mirtazapine 30 mg daily
Drug: mirtazapine
mirtazapine 30 mg daily for 3 months
Other Name: Remeron
Placebo Comparator: Placebo
placebo 30 mg daily
Drug: placebo
placebo 30 mg daily for 3 months

Outcome Measures

Primary Outcome Measures :
  1. 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) ]
  2. 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).

  3. Frequency of Adverse Events Reported [ Time Frame: From Baseline (week 0) through Final Visit (week 12) ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00497081

United States, California
San Francisco Department of Public Health, Substance Use Research Unit
San Francisco, California, United States, 94102
Sponsors and Collaborators
San Francisco Department of Public Health
National Institute on Drug Abuse (NIDA)
Public Health Foundation Enterprises, Inc.
Principal Investigator: Grant N Colfax, MD Co-Directior, HIV Epidemiology Section, San Francisco Department of Public Health
More Information

Responsible Party: Phillip Coffin, MD, MIA, Principal Investigator, San Francisco Department of Public Health
ClinicalTrials.gov Identifier: NCT00497081     History of Changes
Other Study ID Numbers: 1R01DA022155-01 ( U.S. NIH Grant/Contract )
R01DA022155 ( U.S. NIH Grant/Contract )
DPMC ( Other Identifier: NIDA )
First Posted: July 6, 2007    Key Record Dates
Results First Posted: October 20, 2014
Last Update Posted: January 5, 2015
Last Verified: December 2014

Keywords provided by Phillip Coffin, MD, MIA, San Francisco Department of Public Health:
HIV Seronegativity

Additional relevant MeSH terms:
HIV Infections
Substance-Related Disorders
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Chemically-Induced Disorders
Mental Disorders
Central Nervous System Stimulants
Physiological Effects of Drugs
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors
Adrenergic alpha-Antagonists
Adrenergic Antagonists