Alcohol Pharmacotherapy for HIV+ Prisoners (INSPIRE)

This study is currently recruiting participants.
Verified August 2011 by Yale University
Sponsor:
Collaborator:
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT01077310
First received: February 19, 2010
Last updated: August 4, 2011
Last verified: August 2011

February 19, 2010
August 4, 2011
August 2010
August 2014   (final data collection date for primary outcome measure)
  • log10 HIV-1 RNA levels (copies/mL) [ Time Frame: Baseline, and every 3 months for 1 year ] [ Designated as safety issue: No ]
    Baseline labs will be drawn while subjects is in prison, one to three months prior to release. Additional labs will be drawn every 3 months for 1 year to monitor changes in HIV-1 RNA levels.
  • CD4 cell count (cells/mL) [ Time Frame: Baseline and every 3 months for 1 year ] [ Designated as safety issue: No ]
    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.
HIV treatment outcomes: log10 HIV-1 RNA levels (copies/mL) and CD4 counts (cells/mL) [ Time Frame: 12 weeks prior to release from prison (baseline), day of release, then at months 3, 6, 9, 12 post-release ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01077310 on ClinicalTrials.gov Archive Site
  • Alcohol treatment outcome: time to alcohol relapse [ Time Frame: 12 weeks prior to release from prison (baseline), day of release, then every month until 12 months post-release ] [ Designated as safety issue: No ]
  • Alcohol treatment outcome: lower percent days drinking [ Time Frame: 12 weeks prior to release from prison (baseline), day of release, then every month until 12 months post-release ] [ Designated as safety issue: No ]
  • Alcohol treatment outcome: higher percent days abstinent [ Time Frame: 12 weeks prior to release from prison (baseline), day of release, then every month until 12 months post-release ] [ Designated as safety issue: No ]
  • Alcohol treatment outcome: lower addiction severity [ Time Frame: 12 weeks prior to release from prison (baseline), day of release, then every month until 12 months post-release ] [ Designated as safety issue: No ]
  • Alcohol treatment outcome: lower craving for alcohol [ Time Frame: 12 weeks prior to release from prison (baseline), day of release, then every month until 12 months post-release ] [ Designated as safety issue: No ]
  • Alcohol treatment outcome: time to alcohol relapse [ Time Frame: 12 weeks prior to release from prison (baseline), day of release, then monthly until 12 months post-release ] [ Designated as safety issue: No ]
  • Alcohol treatment outcome: lower percent days drinking [ Time Frame: 12 weeks prior to release from prison (baseline), day of release, then monthly until 12 months post-release ] [ Designated as safety issue: No ]
  • Alcohol treatment outcome: higher percent days abstinent [ Time Frame: 12 weeks prior to release from prison (baseline), day of release, then monthly until 12 months post-release ] [ Designated as safety issue: No ]
  • Alcohol treatment outcome: lower addiction severity [ Time Frame: 12 weeks prior to release from prison (baseline), day of release, then monthly until 12 months post-release ] [ Designated as safety issue: No ]
  • Alcohol treatment outcome: lower craving for alcohol [ Time Frame: 12 weeks prior to release from prison (baseline), day of release, then monthly until 12 months post-release ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Alcohol Pharmacotherapy for HIV+ Prisoners
Randomized Controlled Trial of Injectable Depot-naltrexone Versus Placebo Among Human Immunodeficiency (HIV) Infected Prisoners Meeting Diagnostic and Statistical Manual IV (DSM-IV) Criteria for Alcohol Dependence or Problem Drinking

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.

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 lower changes in log10 HIV-1 RNA levels, higher CD4 counts and higher rates of retention in care.

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

iii. XR-NTX will result in reduced drug- and sex-related HIV risk behaviors compared to the control group.

iv. XR-NTX will result in decreased rates of reincarceration after 12 months of release to the community.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Alcohol Dependence
  • Problem Drinking
  • Hazardous Drinking
  • Human Immunodeficiency Virus
  • AIDS
  • Drug: 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.
    Other Names:
    • VIVITROL
    • extended release naltrexone
    • Intamuscular naltrexone
    • Depot-naltrexone
  • 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.
    Other Name: Saline
  • Active Comparator: 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.
    Intervention: Drug: Vivitrol- Intramuscular naltrexone (depot-formulation)
  • Placebo Comparator: 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.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
125
August 2014
August 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Ruthanne Marcus 2037649958 ruthanne.marcus@yale.edu
Contact: Angela DiPaola 2037375530 angela.dipaola@yale.edu
United States
 
NCT01077310
0908005572, 1R01AA018944
No
Dr. Sandra Springer, Yale University School of Medicine
Yale University
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Principal Investigator: Sandra A Springer, MD Yale University
Principal Investigator: Frederick L Altice, MD Yale University
Yale University
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP