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

NCT ID: NCT01449565

Last Updated: 2016-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2016-03-31

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.

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).

Conditions

Amphetamine-Related Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Naltrexone

Group Type: ACTIVE_COMPARATOR

Naltrexone

Intervention Type: DRUG

3 monthly intramuscular injections of naltrexone 380 mg (extended release)

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

3 monthly intramuscular injections of placebo, matched to naltrexone 380 mg (extended release)

Interventions

Naltrexone

3 monthly intramuscular injections of naltrexone 380 mg (extended release)

Intervention Type: DRUG

Placebo

3 monthly intramuscular injections of placebo, matched to naltrexone 380 mg (extended release)

Intervention Type: DRUG

Other Intervention Names

XR-NTX; VIVITROL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Alkermes, Inc.

INDUSTRY

Sponsor Role: collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

San Francisco Department of Public Health

OTHER_GOV

Sponsor Role: lead

Responsible Party

Phillip Coffin, MD, MIA

Director, Substance Use Research Unit

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Steven L. Batki, MD

Role: PRINCIPAL_INVESTIGATOR

Substance Abuse Programs, San Francisco VA Medical Center

Phillip Coffin, MD, MIA

Role: PRINCIPAL_INVESTIGATOR

Substance Use Research Unit, San Francisco Department of Public Health

Emily Behar, MS

Role: STUDY_DIRECTOR

San Francisco Department of Public Health

Locations

Substance Use Research Unit

San Francisco, California, United States

Countries

United States

Other Identifiers

R01DA031678

Identifier Type: NIH

Identifier Source: secondary_id

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R01DA031678

Identifier Type: NIH

Identifier Source: org_study_id

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