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Sponsored by: |
National Institute on Drug Abuse (NIDA) |
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Information provided by: | National Institute on Drug Abuse (NIDA) |
ClinicalTrials.gov Identifier: | NCT00497055 |
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 is a randomized, double-blind, placebo-controlled trial of the medication aripiprazole for methamphetamine-using MSM, and will assess efficacy, acceptability, tolerability, safety, and adherence to study medication.
Condition | Intervention | Phase |
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Substance Abuse HIV Infections |
Drug: aripiprazole |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety Study |
Official Title: | Aripiprazole Treatment for Methamphetamine Dependence Among High-Risk MSM |
Estimated Enrollment: | 90 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | January 2010 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator |
Drug: aripiprazole
aripiprazole 20 mg daily for 3 months
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2: Placebo Comparator |
Drug: aripiprazole
aripiprazole 20 mg daily for 3 months
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Population-based surveys estimate that the prevalence of methamphetamine use is 20 times higher among men who have sex with men (MSM) compared to the general population. Methamphetamine-associated sexual risk behavior is also a driving force in the MSM HIV epidemic: methamphetamine use has been associated with increased number of sexual partners, unprotected sex acts, sexually transmitted infections (STIs), and HIV acquisition. Despite these alarming data, relatively few interventions have been tested among methamphetamine-using MSM. In parallel with the continued testing of behavioral approaches, we believe the time has come to test the feasibility and acceptability of pharmacologic interventions to reduce methamphetamine use among MSM. Pharmacologic approaches to treating substance use have been successful in treating nicotine, alcohol, and heroin dependencies. Preliminary dosing studies demonstrate that aripiprazole (Abilify), an FDA-approved, well-tolerated antipsychotic and partial dopamine agonist, reduced the effects of methamphetamine in humans and exhibited a good safety profile. We propose to expand upon these promising results by conducting a randomized, double-blind, placebo-controlled pilot study of aripiprazole among sexually-active, methamphetamine-dependent MSM.
The specific aims of this study are:
If promising, study results will be used to design larger, definitive clinical trials to determine the efficacy of aripiprazole in reducing methamphetamine use and corresponding methamphetamine-associated sexual risk among MSM. This pilot study is therefore designed to reflect the structure of such trials. We will enroll 90 sexually active, methamphetamine-dependent MSM who will be randomized 1:1 to receive aripiprazole (n=45) or placebo (n=45) for 12 weeks. Because we are testing a drug for a new indication in a new population, we will include extensive safety parameters, as done in prior studies of pharmacologic interventions among substance users. We will also include both urine testing and extensive behavioral risk assessments because we anticipate that future definitive efficacy trials will analyze both substance use and sexual risk behavior outcomes. Study participants will be seen at the San Francisco Department of Public Health AIDS Office where they will provide urines for drug testing and participate in substance use counseling. All participants will receive HIV risk-reduction counseling. Behavior will be assessed using standardized measures via audio computer-assisted self-interview (ACASI).
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
A total of 90 MSM with methamphetamine dependence will be enrolled in the study. Subjects will be San Francisco residents between 18-50 years of age and in good health. The project is designed specifically for MSM at high risk for HIV transmission or acquisition.
Inclusion Criteria:
Exclusion Criteria:
Contact: Deirdre Santos, FNP | 415-703-7273 | deirdre.santos@sfdph.org |
United States, California | |
San Francisco Department of Public Health, AIDS Office | Recruiting |
San Francisco, California, United States, 94102 | |
Contact: Deirdre Santos, FNP 415-703-7273 deirdre.santos@sfdph.org |
Principal Investigator: | Grant N Colfax, MD | Directior, HIV Prevention Section, San Francisco Department of Public Health |
Responsible Party: | HIV Prevention Section, San Francisco Dept of Public Health ( Grant Colfax, MD ) |
Study ID Numbers: | 1RO1DA022190-01 |
Study First Received: | July 5, 2007 |
Last Updated: | August 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00497055 |
Health Authority: | United States: Federal Government |
Methamphetamine HIV MSM HIV Seronegativity |
Sexually Transmitted Diseases, Viral Acquired Immunodeficiency Syndrome Disorders of Environmental Origin Immunologic Deficiency Syndromes Virus Diseases Methamphetamine Dopamine |
HIV Infections Mental Disorders Sexually Transmitted Diseases Substance-Related Disorders Amphetamine Aripiprazole Retroviridae Infections |
Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors RNA Virus Infections Neurotransmitter Agents Tranquilizing Agents Slow Virus Diseases Adrenergic Agents Immune System Diseases Molecular Mechanisms of Pharmacological Action Adrenergic Uptake Inhibitors Sympathomimetics Physiological Effects of Drugs |
Psychotropic Drugs Central Nervous System Depressants Central Nervous System Stimulants Antipsychotic Agents Infection Pharmacologic Actions Autonomic Agents Therapeutic Uses Lentivirus Infections Dopamine Agents Peripheral Nervous System Agents Central Nervous System Agents |