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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by San Francisco Department of Public Health
Sponsor:
Collaborators:
Alkermes, Inc.
Information provided by (Responsible Party):
Phillip Coffin, MD, MIA, San Francisco Department of Public Health
ClinicalTrials.gov Identifier:
NCT01449565
First received: October 4, 2011
Last updated: October 7, 2014
Last verified: October 2014
  Purpose

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 Intervention Phase
Amphetamine-Related Disorders
Drug: Naltrexone
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by San Francisco Department of Public Health:

Primary Outcome Measures:
  • urine meth positivity [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    proportion of meth-metabolite positive urines by study arm, measured weekly from week 0 through week 12


Secondary Outcome Measures:
  • reduction in sexual risk behavior [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    reduction in meth-associated sexual risk behavior as measured by: numbers of male anal sex partners, serodiscordant unprotected anal sex partners, and numbers of sex partners with whom meth was used, by study arm

  • percentage of total expected injections administered [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    acceptability of extended-release naltrexone vs placebo, as measured by the percentage of total expected injections administered, by study arm

  • rates of adverse events [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    rates of adverse events will be compared by study arm


Estimated Enrollment: 100
Study Start Date: September 2012
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Naltrexone Drug: Naltrexone
3 monthly intramuscular injections of naltrexone 380 mg (extended release)
Other Names:
  • XR-NTX
  • VIVITROL
Placebo Comparator: Placebo Drug: Placebo
3 monthly intramuscular injections of placebo, matched to naltrexone 380 mg (extended release)

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).

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01449565

Contacts
Contact: Jason Euren, MA 415.437.6276 jason.euren@sfdph.org

Locations
United States, California
San Francisco Department of Public Health Recruiting
San Francisco, California, United States, 94102
Principal Investigator: Phillip Coffin, MD, MIA         
Sponsors and Collaborators
San Francisco Department of Public Health
Alkermes, Inc.
Investigators
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: Jason Euren, MA San Francisco Department of Public Health
  More Information

No publications provided

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, R01DA031678
Study First Received: October 4, 2011
Last Updated: October 7, 2014
Health Authority: United States: Federal Government
United States: Food and Drug Administration
United States: Institutional Review Board
United States: Data and Safety Monitoring Board

Keywords provided by San Francisco Department of Public Health:
methamphetamine
high-risk sexual behavior
HIV prevention

Additional relevant MeSH terms:
Amphetamine-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders
Methamphetamine
Naltrexone
Adrenergic Agents
Adrenergic Uptake Inhibitors
Autonomic Agents
Central Nervous System Agents
Central Nervous System Stimulants
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Narcotic Antagonists
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Sympathomimetics
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014