Alcohol Pharmacotherapy for HIV+ Prisoners (INSPIRE)

Yale University

Status: Completed

Conditions: AIDS; Human Immunodeficiency Virus; Hazardous Drinking; Problem Drinking; Alcohol Dependence

Treatments: Drug: Placebo; Drug: Vivitrol- Intramuscular naltrexone (depot-formulation)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01077310

0908005572

1R01AA018944 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This is a randomized controlled trial of injectable intramuscular naltrexone (XR-NTX) versus intramuscular placebo among HIV-infected prisoners meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for alcohol dependence or problem drinking, who are transitioning to the community and seeking treatment to prevent relapse to alcohol use. We hypothesize that extended release naltrexone (XR-NTX) will result in improved HIV outcomes (lower log10 HIV-1RNA levels and higher CD4 count) as well as improved alcohol treatment outcomes, and reduced drug/sex HIV related risk behaviors and decreased rates of reincarceration.

Full description

INSPIRE is a randomized controlled trial of injectable intramuscular NTX (XR-NTX) versus intramuscular placebo among Human Immunodeficiency (HIV) infected prisoners meeting DSM-IV criteria for alcohol dependence or problem drinking, who are transitioning to the community and seeking treatment to prevent relapse to alcohol use. While the COMBINE trial has demonstrated the effectiveness of oral naltrexone in a group of active alcohol dependent persons in decreasing relapse to alcohol use over placebo, naltrexone has not been studied in people who have a history of current alcohol dependence prior to incarceration, are incarcerated and not actively using alcohol and are likely to return to alcohol use when released. In this study, we conduct a placebo-controlled trial to determine if naltrexone has an effect in this group, which could be important in making the case for having naltrexone available to alcohol dependent or problem drinking HIV+ prisoners prior to release. We will compare their HIV treatment (HIV-1 RNA levels, CD4 count), alcohol treatment (time to relapse to heavy drinking, percent of days drinking, percent of days abstinent and alcohol craving) and HIV risk behavior (sexual and drug-related risks) outcomes. The hypotheses include:

i. XR-NTX will result in improved HIV clinical outcomes, including changes in HIV-1 RNA levels, and higher CD4 counts.

ii. XR-NTX will result in improved alcohol treatment outcomes, including longer time to alcohol relapse, lower percent days drinking, and lower craving for alcohol.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. HIV+
2. Inmates returning to New Haven or Hartford
3. Meets criteria for alcohol dependence (using Diagnostic and Statistical Manual IV) or problem drinking (using Alcohol Use Disorder Identification Test-AUDIT)
4. Gives informed consent
5. English or Spanish speaker
6. > 18 yrs

Exclusion criteria

1. On opiate pain medication or expressing need for them
2. Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) > 5x the upper limit of normal
3. Evidence of Child's Pugh Class C cirrhosis
4. Pending felony charges
5. Pregnant or unwilling to take contraceptive measures
6. Subject is part of another pharmacological research study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

Intramuscular naltrexone

Active Comparator group

Description:

Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail.

Treatment:

Drug: Vivitrol- Intramuscular naltrexone (depot-formulation)

Placebo

Placebo Comparator group

Description:

Subjects in this arm will receive monthly intramuscular gluteal injections of placebo for 6 months. The 1st injection will be administered prior to release from prison or jail.

Treatment:

Drug: Placebo