Alcohol Pharmacotherapy for HIV+ Prisoners

NCT ID: NCT01077310

Last Updated: 2017-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2015-08-31

Brief Summary

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.

Detailed 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.

Conditions

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

Study Design

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

Study Groups

Intramuscular naltrexone

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.

Group Type: ACTIVE_COMPARATOR

Vivitrol- Intramuscular naltrexone (depot-formulation)

Intervention Type: DRUG

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.

Placebo

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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. Placebo will be provided by Alkermes pharmaceuticals, the manufacturer of VIVITROL. Placebo will be identical in shape and form to active drug.

Interventions

Vivitrol- Intramuscular naltrexone (depot-formulation)

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.

Intervention Type: DRUG

Placebo

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. Placebo will be provided by Alkermes pharmaceuticals, the manufacturer of VIVITROL. Placebo will be identical in shape and form to active drug.

Intervention Type: DRUG

Other Intervention Names

VIVITROL; extended release naltrexone; Intramuscular naltrexone; Depot-naltrexone; Saline

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sandra A Springer, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Frederick L Altice, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale Clinical Research

New Haven, Connecticut, United States

Countries

United States

References

Springer SA, Altice FL, Herme M, Di Paola A. Design and methods of a double blind randomized placebo-controlled trial of extended-release naltrexone for alcohol dependent and hazardous drinking prisoners with HIV who are transitioning to the community. Contemp Clin Trials. 2014 Mar;37(2):209-18. doi: 10.1016/j.cct.2013.12.006. Epub 2013 Dec 31.

Reference Type: BACKGROUND

PMID: 24384538 (View on PubMed)

Vagenas P, Di Paola A, Herme M, Lincoln T, Skiest DJ, Altice FL, Springer SA. An evaluation of hepatic enzyme elevations among HIV-infected released prisoners enrolled in two randomized placebo-controlled trials of extended release naltrexone. J Subst Abuse Treat. 2014 Jul;47(1):35-40. doi: 10.1016/j.jsat.2014.02.008. Epub 2014 Mar 12.

Reference Type: RESULT

PMID: 24674234 (View on PubMed)

Springer SA, Brown SE, Di Paola A, Altice FL. Correlates of retention on extended-release naltrexone among persons living with HIV infection transitioning to the community from the criminal justice system. Drug Alcohol Depend. 2015 Dec 1;157:158-65. doi: 10.1016/j.drugalcdep.2015.10.023. Epub 2015 Oct 28.

Reference Type: RESULT

PMID: 26560326 (View on PubMed)

Springer SA, Di Paola A, Barbour R, Azar MM, Altice FL. Extended-release Naltrexone Improves Viral Suppression Among Incarcerated Persons Living with HIV and Alcohol use Disorders Transitioning to the Community: Results From a Double-Blind, Placebo-Controlled Trial. J Acquir Immune Defic Syndr. 2018 Sep 1;79(1):92-100. doi: 10.1097/QAI.0000000000001759.

Reference Type: DERIVED

PMID: 29781884 (View on PubMed)

Other Identifiers

1R01AA018944

Identifier Type: NIH

Identifier Source: secondary_id

View Link

0908005572

Identifier Type: -

Identifier Source: org_study_id