Alcohol Pharmacotherapy for HIV+ Prisoners

Human Immunodeficiency Virus Clinical Trial

— INSPIRE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01077310
• Other study ID #: 0908005572
• Secondary ID: 1R01AA018944
• Status: Completed
• Phase: N/A
• First received: February 19, 2010
• Last updated: March 7, 2016
• Start date: August 2010
• Est. completion date: August 2015

Study information

• Verified date: March 2016
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• AIDS
• Alcohol Dependence
• Alcoholism
• Hazardous Drinking
• HIV Infections
• Human Immunodeficiency Virus
• Immunologic Deficiency Syndromes
• Problem Drinking

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Yale Clinical Research	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

Springer SA, Brown SE, Di Paola A. 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.d — View Citation

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 Abu — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	log10 HIV-1 RNA levels (copies/mL)	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.	Baseline, and every 3 months for 1 year	No
Primary	CD4 cell count (cells/mL)	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.	Baseline and every 3 months for 1 year	No
Secondary	Alcohol treatment outcome: time to alcohol relapse		12 weeks prior to release from prison (baseline), day of release, then every month until 12 months post-release	No
Secondary	Alcohol treatment outcome: lower percent days drinking		12 weeks prior to release from prison (baseline), day of release, then every month until 12 months post-release	No
Secondary	Alcohol treatment outcome: higher percent days abstinent		12 weeks prior to release from prison (baseline), day of release, then every month until 12 months post-release	No
Secondary	Alcohol treatment outcome: lower addiction severity		12 weeks prior to release from prison (baseline), day of release, then every month until 12 months post-release	No
Secondary	Alcohol treatment outcome: lower craving for alcohol		12 weeks prior to release from prison (baseline), day of release, then every month until 12 months post-release	No