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Alcohol Pharmacotherapy for HIV+ Prisoners (INSPIRE)

This study has been completed.
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT01077310
First received: February 19, 2010
Last updated: October 4, 2016
Last verified: October 2016
  Purpose
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.

Condition Intervention
Alcohol Dependence
Problem Drinking
Hazardous Drinking
Human Immunodeficiency Virus
AIDS
Drug: Vivitrol- Intramuscular naltrexone (depot-formulation)
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Alcohol Pharmacotherapy for HIV+ Prisoners With Alcohol Dependence and Problem Drinking

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Alcohol Treatment Outcome: Time to Alcohol Relapse [ Time Frame: Post release ] [ Designated as safety issue: No ]
    Self reported time to first heavy drinking day after release from incarceration, up to 6 months

  • 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 ] [ Designated as safety issue: No ]
    The mean change from 12 weeks pre incarceration to 6 months post release from incarceration in average drinks per drinking day

  • 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 ] [ Designated as safety issue: No ]
    change in the percent of heavy drinking days from 12 weeks prior to incarceration to 6 months post release from incarceration.


Other Outcome Measures:
  • Mean Change in 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.


Enrollment: 100
Study Start Date: August 2010
Study Completion Date: August 2015
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
  • Intramuscular naltrexone
  • Depot-naltrexone
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.
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01077310

Locations
United States, Connecticut
Yale Clinical Research
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Yale University
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
Principal Investigator: Sandra A Springer, MD Yale University
Principal Investigator: Frederick L Altice, MD Yale University
  More Information

Publications:
Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01077310     History of Changes
Other Study ID Numbers: 0908005572  1R01AA018944 
Study First Received: February 19, 2010
Results First Received: August 4, 2016
Last Updated: October 4, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Yale University:
HIV
Acquired Immunodeficiency Syndrome
Alcohol dependence
CD4
HIV-1 RNA
Alcohol treatment outcomes

Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections
Alcoholism
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ethanol
Naltrexone
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Narcotic Antagonists
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on December 02, 2016