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

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.

Study Overview

• Status: Completed
• Conditions: Amphetamine-Related Disorders
• Intervention / Treatment: Drug: Naltrexone; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94102
      • Substance Use Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
urine meth positivity	proportion of meth-metabolite positive urines by study arm, measured weekly from week 0 through week 12	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
reduction in sexual risk behavior	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	12 weeks
percentage of total expected injections administered	acceptability of extended-release naltrexone vs placebo, as measured by the percentage of total expected injections administered, by study arm	12 weeks
rates of adverse events	rates of adverse events will be compared by study arm	12 weeks

Collaborators and Investigators

• Sponsor: San Francisco Department of Public Health
• Collaborators: National Institute on Drug Abuse (NIDA); Alkermes, Inc.
• Investigators: Study Director: Emily Behar, MS, San Francisco Department of Public Health; 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 record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: October 4, 2011
• First Submitted That Met QC Criteria: October 6, 2011
• First Posted (Estimate): October 10, 2011

Study Record Updates

• Last Update Posted (Estimate): April 13, 2016
• Last Update Submitted That Met QC Criteria: April 11, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: HIV prevention; methamphetamine; high-risk sexual behavior
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Amphetamine-Related Disorders; Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Narcotic Antagonists; Alcohol Deterrents; Naltrexone
• Other Study ID Numbers: R01DA031678 (U.S. NIH Grant/Contract)