Human Immunodeficiency Virus Clinical Trial
— INSPIREOfficial title:
Alcohol Pharmacotherapy for HIV+ Prisoners With Alcohol Dependence and Problem Drinking
Verified date | March 2016 |
Source | Yale University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Yale Clinical Research | New Haven | Connecticut |
Lead Sponsor | Collaborator |
---|---|
Yale University | National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
United States,
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
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 |
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