Ignite Creation Date:
2024-05-05 @ 10:18 PM
Last Modification Date:
2024-10-26 @ 10:16 AM
Study NCT ID:
NCT01077310
Status:
COMPLETED
Last Update Posted:
2017-05-30
First Post:
2010-02-19
Brief Title:
Alcohol Pharmacotherapy for HIV Prisoners
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
Alcohol Pharmacotherapy for HIV Prisoners With Alcohol Dependence and Problem Drinking
Status:
COMPLETED
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INSPIRE
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 drugsex HIV related risk behaviors and decreased rates of reincarceration
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01AA018944 | NIH | None | httpsreporternihgovquickSearch1R01AA018944 |