Alcohol Pharmacotherapy for HIV+ Prisoners

NCT01077310 | Completed Results

• 2 other identifiers: 09080055721R01AA018944
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

HIV; Acquired Immunodeficiency Syndrome; Alcohol dependence; CD4; HIV-1 RNA; Alcohol treatment outcomes

Outcome Measures

Primary Outcomes (1)

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

  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.

  Baseline to month 6 post release

Secondary Outcomes (3)

• Alcohol Treatment Outcome: Time to Alcohol Relapse

  Post release

• Alcohol Treatment Outcome: Change in Average Drinks Per Drinking Day

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

• Alcohol Treatment Outcome: Change in Percent of Heavy Drinking Days

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

Other Outcomes (1)

• Mean Change in CD4 Cell Count (Cells/mL)

  Baseline and every 3 months for 1 year

Study Arms (2)

Intramuscular naltrexone

ACTIVE COMPARATOR

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)

Placebo

PLACEBO COMPARATOR

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

Interventions

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.

Also known as: VIVITROL, extended release naltrexone, Intramuscular naltrexone, Depot-naltrexone

Intramuscular 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.

Also known as: Saline

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Yale Clinical Research

New Haven, Connecticut, 06511, United States

Location

Related Publications (4)

• 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.

  PMID: 24384538 BACKGROUND

• 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.

  PMID: 24674234 RESULT

• 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.

  PMID: 26560326 RESULT

• 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.

  PMID: 29781884 DERIVED

MeSH Terms

Conditions

Alcoholism; Acquired Immunodeficiency Syndrome

Interventions

vivitrol; Sodium Chloride

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Principle Investigator
• Organization: Yale School of Medicine

sandra.springer@yale.edu

203-737-2883

Study Officials

• Sandra A Springer, MD

  Yale University

  PRINCIPAL INVESTIGATOR

• Frederick L Altice, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2010
• First Posted: March 1, 2010
• Study Start: August 1, 2010
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: May 30, 2017
• Results First Posted: November 25, 2016

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)