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

NCT01449565 | Completed Phase 2 DMC

• 1 other identifier: R01DA031678
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Amphetamine-Related Disorders

Keywords

methamphetamine; high-risk sexual behavior; HIV prevention

Outcome Measures

Primary Outcomes (1)

• urine meth positivity

  proportion of meth-metabolite positive urines by study arm, measured weekly from week 0 through week 12

  12 weeks

Secondary Outcomes (3)

• reduction in sexual risk behavior

  12 weeks

• percentage of total expected injections administered

  12 weeks

• rates of adverse events

  12 weeks

Study Arms (2)

Naltrexone

ACTIVE COMPARATOR

Drug: Naltrexone

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Naltrexone DRUG

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

Also known as: XR-NTX, VIVITROL

Naltrexone

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• born male; or born female and does not identify as female
• reports having anal sex with men in the prior six months while under the influence of meth;
• diagnosed with meth dependence as determined by SCID;
• interested in stopping or reducing meth use;
• at least one meth-positive urine during screening and run-in period;
• no current acute illnesses requiring prolonged medical care;
• no chronic illnesses that are likely to progress clinically during trial participation;
• able and willing to provide informed consent and adhere to visit schedule;
• age 18-65 years;
• 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.

You may not qualify if:

• any psychiatric condition (e.g. current depression with suicidal ideation or schizophrenia) that would preclude safe participation in the protocol;
• known intolerance and/or hypersensitivity to naltrexone, carboxymethylcellulose, or polylactide-co-polymers (PLG) or any other components of the diluents;
• 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
• diagnosed with current alcohol dependence as determined by the SCID;
• current CD4 count \< 200 cells/mm3;
• moderate or severe liver disease (AST and/or ALT \> 5 times upper limit of normal);
• moderately or severely impaired renal function (eGFR \< 50 mL/min);
• thrombocytopenia or other coagulation disorder
• currently participating in another research study;
• pending legal proceedings with high risk for incarceration during the time of planned study participation;
• any condition that, in the principal investigator's judgment, interferes with safe study participation or adherence to study procedures.

Sponsors & Collaborators

• San Francisco Department of Public Health: lead
• Alkermes, Inc.: collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Substance Use Research Unit

San Francisco, California, 94102, United States

Location

MeSH Terms

Conditions

Amphetamine-Related Disorders

Interventions

Naltrexone; vivitrol

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• Emily Behar, MS

  San Francisco Department of Public Health

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Substance Use Research Unit

Study Record Dates

• First Submitted: October 4, 2011
• First Posted: October 10, 2011
• Study Start: September 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: March 1, 2016
• Last Updated: April 13, 2016

Record last verified: 2016-04

Locations

US (1)