HIV Clinical Trial
— NewHopeOfficial title:
Naltrexone for Opioid Dependent Released Human Immunodeficiency Virus Positive (HIV+) Criminal Justice Populations
Verified date | June 2017 |
Source | Yale University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Specific Aim: To conduct a randomized, placebo-controlled trial of extended
release-naltrexone (XR-NTX) among Human Immunodeficiency Virus (HIV) infected prisoners
meeting Diagnostic Statistical Manual IV (DSM-IV) criteria for opioid dependence who are
transitioning from the structure of a correctional setting to the community.
Hypotheses:
i. XR-NTX will result in improved HIV clinical outcomes, including lower changes in HIV-1 RNA
levels, higher CD4 counts and higher rates of retention in care.
ii. XR-NTX will result in improved opioid treatment outcomes, including longer time to opioid
relapse, lower addiction severity and lower craving for opioid.
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.
Status | Completed |
Enrollment | 151 |
Est. completion date | July 2016 |
Est. primary completion date | March 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Meets DSM-IV criteria for opioid dependence 2. Age > 18 years 3. Confirmed HIV infection, either through positive HIV antibody or detectable HIV-1 RNA level. 4. Within the Connecticut Department of Corrections (CTDOC) or Hampden County Correctional Center (HCCC) and within 30 days of being released to the greater New Haven, Hartford or Springfield areas or within 30 days after release from CTDOC or HCCC. 5. No participation in pharmacotherapy trial in the previous 30 days 6. Not pregnant Exclusion Criteria: 1. Unable to provide informed consent 2. Verbally or physically threatening to research staff 3. Unable to communicate in either English or Spanish 4. Pending trials for a felony 5. Liver failure (Childs-Pugh Class B or C Cirrhosis) 6. Grade IV Hepatitis (liver function tests > 10X normal) 7. Receiving opioid prescription narcotics or has pain syndrome necessitating future use of opioid prescription narcotics. 8. Receiving active methadone or buprenorphine/naloxone for the treatment of opioid dependency 9. Active opioid withdrawal (within 3-5 days since last opioid ingestion) 10. Pregnancy or unwilling to take contraceptives measures 11. Breast-feeding |
Country | Name | City | State |
---|---|---|---|
United States | Yale University | Hartford | Connecticut |
United States | Yale University | New Haven | Connecticut |
United States | Baystate Medical Center | Springfield | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Yale University | Baystate Medical Center, National Institute on Drug Abuse (NIDA) |
United States,
Di Paola A, Lincoln T, Skiest DJ, Desabrais M, Altice FL, Springer SA. Design and methods of a double blind randomized placebo-controlled trial of extended-release naltrexone for HIV-infected, opioid dependent prisoners and jail detainees who are transitioning to the community. Contemp Clin Trials. 2014 Nov;39(2):256-68. doi: 10.1016/j.cct.2014.09.002. Epub 2014 Sep 18. — View Citation
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: — 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 | Participants Who Had Undetectable HIV-1 RNA Levels at Less Than 400 Copies/mL at Six Month | Baseline labs will be drawn while subject is in prison, one to three months prior to release. Additionally, labs will be drawn every 3 months for 1 year to monitor changes in HIV-1 RNA levels. Treatment time period was the first 6 months where the primary outcome data will be based on. | 6 months | |
Secondary | Particpants Who Had Undetectable HIV-1 RNA Levels at Less Than 50 Copies/mL | Baseline labs will be drawn while subject is in prison, one to three months prior to release. Additionally, labs will be drawn every 3 months for 1 year to monitor changes in HIV-1 RNA levels. Treatment time period was the first 6 months where the primary outcome data will be based on. | 6 months | |
Secondary | CD4 Cell Count (Cells/mL) | Baseline labs will be drawn while subject 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 CD4 levels. | Baseline and 6 months | |
Secondary | Time to Opioid Relapse or End of Intervention | Measuring days to first relapse based on self reported opioids (heroin) use within the 6 month (180 days) intervention period. If participants had no follow-up visits, and thus no self reported opiate use, they were treated as missing. Those who did not relapse within the 6 month intervention period were treated as having 180 days until relapse. | 6 months | |
Secondary | Addiction Severity | The Addiction Severity Index (ASI) questionnaire will be used to assess addiction severity. The ASI composite scoreprovides reliable and valid measure of patient status in a particular module of interest which can then be usecompared at the beginning of treatment to the evaluation endpoint to note the improvement or lack thereof. In this assessment the drug composite score was calculated using algorithm by Treatment Research Institute. If the score increases then it shows increase in severity where as if it decreases then it shows decrease in severity for that measured module. The scale ranges from 0 to 1. The mean composite scores for drug use from baseline to 6 months were compared using Nonparametric test. |
baseline, and 6 months | |
Secondary | Craving for Opioids | Craving at baseline compared to 6 month. This is assessed through a self report scale rated 0 to 10; 0 meaning not craving and 10 meaning highest craving. Change in craving score was categorized as 1)no change between baseline and 6 month; 2)increased craving - baseline craving was reported lower than at 6 month; 3)decreased craving - baseline craving was reported higher than 6 month craving. | 6 months | |
Secondary | Antiretroviral Therapy (ART) Adherence 100% | Number of subjects with 100% adherence at 6 months measured using Visual Analogue Scale: 0% to 100% | 6 months | |
Secondary | Participants With Opiate Abstinence Via By Doing Urine Toxicology Test | Percent of subjects with no opiate use at 6 month. Missing data was treated as failure (opiate positive). | 6 month | |
Secondary | Opioid Abstinence at 6 Months for Those With More Than 4 Injections | Based on self reported opioids (heroin) use. All participants receiving Placebo as well as participants who received 3 or less XR-NTX injections were compared to those who receive 4 or more XR-NTX injection. | 6 months | |
Secondary | ART Adherence for 4 or More Injections XR-NTX Versus Placebo and 3 or Less Injections of XR-NTX | The arm/group number of the participants vary from the primary outcome because this is a treatment effect analysis. All client with missing data at 6 months were considered as failure - meaning - they had less than 100% ART adherence. | 6 months |
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