Skip to main content
OpenTrials
Completed

NCT Number: NCT01077310

Alcohol Pharmacotherapy for HIV+ Prisoners

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Alcohol Dependence AIDS Acquired Immunodeficiency Syndrome Alcohol-Related Disorders Alcoholism Blood-Borne Infections Chemically-Induced Disorders Communicable Diseases Genital Diseases HIV Infections Hazardous Drinking Human Immunodeficiency Virus Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Mental Disorders Problem Drinking RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Substance-Related Disorders Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale Clinical Research

New Haven, Connecticut, 06511, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Vivitrol- Intramuscular naltrexone (depot-formulation)

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.

Other names: VIVITROL, extended release naltrexone, Intramuscular naltrexone, Depot-naltrexone

Placebo

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.

Other names: Saline

Primary outcomes

  1. Percentage of Those Maintain or Improve to HIV RNA-1 Viral Load Less Then 400 Copies/mL

    Time frame: Baseline to month 6 post release

    Percentage of participants that maintained or improved a level of undetectable HIV viral load from baseline (closest viral load to time of release from incarceration) to 6 months post release. Missing lab values were considered to have a detectable HIV viral load.

Secondary outcomes

  1. Alcohol Treatment Outcome: Time to Alcohol Relapse

    Time frame: Post release

    Self reported time to first heavy drinking day after release from incarceration, up to 6 months

  2. Alcohol Treatment Outcome: Change in Average Drinks Per Drinking Day

    Time frame: 12 weeks prior to release from prison (baseline) to 6 months post release

    The mean change from 12 weeks pre incarceration to 6 months post release from incarceration in average drinks per drinking day

  3. Alcohol Treatment Outcome: Change in Percent of Heavy Drinking Days

    Time frame: change in percent of heavy drinking days12 weeks prior to release from prison (baseline), day of release, to 6 months post-release

    change in the percent of heavy drinking days from 12 weeks prior to incarceration to 6 months post release from incarceration.

Other outcomes

  1. Mean Change in CD4 Cell Count (Cells/mL)

    Time frame: Baseline and every 3 months for 1 year

    Baseline labs will be drawn while subjects is in prison, one to three months prior to release. Additionally, blood will be drawn every 3 months for 1 year to monitor changes in CD4 cell count.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study title

Alcohol Pharmacotherapy for HIV+ Prisoners With Alcohol Dependence and Problem Drinking

Acronym: INSPIRE

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Mar 1, 2010
Registry last updated
May 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.