Trial record 15 of 40 for:    " February 10, 2010":" March 12, 2010"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

Alcohol Pharmacotherapy for HIV+ Prisoners (INSPIRE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Yale University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Sandra Springer, Yale University
ClinicalTrials.gov Identifier:
NCT01077310
First received: February 19, 2010
Last updated: July 8, 2014
Last verified: July 2014
  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: Randomized Controlled Trial of Injectable Extended-release Naltrexone Versus Placebo Among Human Immunodeficiency (HIV) Infected Prisoners Meeting Diagnostic and Statistical Manual IV (DSM-IV) Criteria for Alcohol Dependence or Problem Drinking

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 125
Study Start Date: August 2010
Estimated Study Completion Date: August 2015
Estimated 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
  • Intamuscular 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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
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

Contacts
Contact: Ruthanne Marcus 2037649958 ruthanne.marcus@yale.edu
Contact: Angela DiPaola 2037375530 angela.dipaola@yale.edu

Locations
United States, Connecticut
Yale Clinical Research Recruiting
New Haven, Connecticut, United States, 06511
Contact: Angela DiPaola, MS    203-764-9995    angela.dipaola@yale.edu   
Principal Investigator: Sandra A Sprigner, MD         
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Sandra A Springer, MD Yale University
Principal Investigator: Frederick L Altice, MD Yale University
  More Information

Publications:
Responsible Party: Sandra Springer, Assistant Professor, Yale University
ClinicalTrials.gov Identifier: NCT01077310     History of Changes
Other Study ID Numbers: 0908005572, 1R01AA018944
Study First Received: February 19, 2010
Last Updated: July 8, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on August 26, 2014