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Extended-Release Naltrexone to Treat Methamphetamine Dependence in Men Who Have Sex With Men (MSM) (TREX)

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ClinicalTrials.gov Identifier: NCT01449565
Recruitment Status : Completed
First Posted : October 10, 2011
Last Update Posted : April 13, 2016
Information provided by (Responsible Party):

Study Description
Brief Summary:
Extended-release naltrexone (XR-NTX, VIVITROL) is an FDA-approved medication with efficacy in treating alcohol dependence and prevention of relapse to opioid dependence. It has shown promise in reducing relapse to amphetamine use among amphetamine-dependent, yet currently amphetamine-abstinent heterosexuals. The investigators will expand upon this promising work to determine whether monthly intramuscular injections of naltrexone will reduce methamphetamine (meth) use among actively using, meth-dependent men who have sex with men (MSM) in this double-blind randomized controlled trial of extended-release naltrexone versus placebo. The investigators will focus on MSM because of the disproportionate and intertwining epidemics of meth use and HIV in this population.

Condition or disease Intervention/treatment Phase
Amphetamine-Related Disorders Drug: Naltrexone Drug: Placebo Phase 2

Detailed Description:
The investigators will enroll 100 sexually active, meth-dependent MSM who will be randomized 1:1 to receive monthly injections of extended-release naltrexone (n=50) or placebo (n=50) for 12 weeks at weeks 0, 4, and 8. Study participants will be seen weekly at our site at the HIV Prevention Section of the San Francisco Department of Public Health, where they will provide urine 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).

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Extended-Release Naltrexone (XR-NTX, VIVITROL) for the Treatment of Actively-Using Methamphetamine-Dependent Men Who Have Sex With Men
Study Start Date : September 2012
Primary Completion Date : December 2015
Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Methamphetamine
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Naltrexone Drug: Naltrexone
3 monthly intramuscular injections of naltrexone 380 mg (extended release)
Other Names:
  • XR-NTX
Placebo Comparator: Placebo Drug: Placebo
3 monthly intramuscular injections of placebo, matched to naltrexone 380 mg (extended release)

Outcome Measures

Primary Outcome Measures :
  1. urine meth positivity [ Time Frame: 12 weeks ]
    proportion of meth-metabolite positive urines by study arm, measured weekly from week 0 through week 12

Secondary Outcome Measures :
  1. reduction in sexual risk behavior [ Time Frame: 12 weeks ]
    reduction in meth-associated sexual risk behavior as measured by: numbers of male anal sex partners, serodiscordant condomless anal sex partners, serodiscordant condomless anal sex events, serodiscordant condomless receptive anal sex partners, serodiscordant condomless receptive anal sex events, serodiscordant condomless insertive anal sex partners, serodiscordant condomless insertive anal sex events, and numbers of sex partners with whom meth was used, by study arm

  2. percentage of total expected injections administered [ Time Frame: 12 weeks ]
    acceptability of extended-release naltrexone vs placebo, as measured by the percentage of total expected injections administered, by study arm

  3. rates of adverse events [ Time Frame: 12 weeks ]
    rates of adverse events will be compared by study arm

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion criteria:

  1. born male; or born female and does not identify as female
  2. reports having anal sex with men in the prior six months while under the influence of meth;
  3. diagnosed with meth dependence as determined by SCID;
  4. interested in stopping or reducing meth use;
  5. at least one meth-positive urine during screening and run-in period;
  6. no current acute illnesses requiring prolonged medical care;
  7. no chronic illnesses that are likely to progress clinically during trial participation;
  8. able and willing to provide informed consent and adhere to visit schedule;
  9. age 18-65 years;
  10. baseline CBC, total protein, albumin, glucose, alkaline phosphatase, creatinine, BUN, total bilirubin, and electrolytes without clinically significant abnormalities as determined by investigator in conjunction with symptoms, physical exam, and medical history.

Exclusion criteria:

  1. any psychiatric condition (e.g. current depression with suicidal ideation or schizophrenia) that would preclude safe participation in the protocol;
  2. known intolerance and/or hypersensitivity to naltrexone, carboxymethylcellulose, or polylactide-co-polymers (PLG) or any other components of the diluents;
  3. current use of or dependence on any opioids; a known medical condition which currently requires or is likely to require opioid analgesics; or positive opioid urine screening tests
  4. diagnosed with current alcohol dependence as determined by the SCID;
  5. current CD4 count < 200 cells/mm3;
  6. moderate or severe liver disease (AST and/or ALT > 5 times upper limit of normal);
  7. moderately or severely impaired renal function (eGFR < 50 mL/min);
  8. thrombocytopenia or other coagulation disorder
  9. currently participating in another research study;
  10. pending legal proceedings with high risk for incarceration during the time of planned study participation;
  11. 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): NCT01449565

United States, California
Substance Use Research Unit
San Francisco, California, United States, 94102
Sponsors and Collaborators
San Francisco Department of Public Health
Alkermes, Inc.
National Institute on Drug Abuse (NIDA)
Principal Investigator: Steven L. Batki, MD Substance Abuse Programs, San Francisco VA Medical Center
Principal Investigator: Phillip Coffin, MD, MIA Substance Use Research Unit, San Francisco Department of Public Health
Study Director: Emily Behar, MS San Francisco Department of Public Health
More Information

Responsible Party: Phillip Coffin, MD, MIA, Director, Substance Use Research Unit, San Francisco Department of Public Health
ClinicalTrials.gov Identifier: NCT01449565     History of Changes
Other Study ID Numbers: R01DA031678 ( U.S. NIH Grant/Contract )
First Posted: October 10, 2011    Key Record Dates
Last Update Posted: April 13, 2016
Last Verified: April 2016

Keywords provided by Phillip Coffin, MD, MIA, San Francisco Department of Public Health:
high-risk sexual behavior
HIV prevention

Additional relevant MeSH terms:
Amphetamine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Stimulants
Autonomic Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors