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 February 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: February 7, 2014
Last verified: February 2014

October 4, 2011
February 7, 2014
September 2012
December 2014   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01449565 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Extended-Release Naltrexone to Treat Methamphetamine Dependence in Men Who Have Sex With Men (MSM)
Extended-Release Naltrexone (XR-NTX, VIVITROL) for the Treatment of Actively-Using Methamphetamine-Dependent Men Who Have Sex With Men

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.

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).

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Amphetamine-Related Disorders
  • Drug: extended-release naltrexone
    3 monthly intramuscular injections of naltrexone 380 mg
    Other Names:
    • XR-NTX
    • VIVITROL
  • Drug: Placebo
    3 monthly intramuscular injections of placebo, matched to naltrexone 380 mg
  • Active Comparator: naltrexone
    Intervention: Drug: extended-release naltrexone
  • Placebo Comparator: placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
March 2015
December 2014   (final data collection date for primary outcome measure)

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.
Male
18 Years to 65 Years
No
Contact: Jason Euren, MA 415.437.6276 jason.euren@sfdph.org
United States
 
NCT01449565
R01DA031678, R01DA031678
Yes
Phillip Coffin, MD, MIA, San Francisco Department of Public Health
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: Jason Euren, MA San Francisco Department of Public Health
San Francisco Department of Public Health
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP