Naltrexone for Opioid Dependent Released Human Immunodeficiency Virus Positive (HIV+) Criminal Justice Populations (NewHope)
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ClinicalTrials.gov Identifier: NCT01246401 |
Recruitment Status
:
Completed
First Posted
: November 23, 2010
Results First Posted
: July 17, 2017
Last Update Posted
: July 17, 2017
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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.
Condition or disease | Intervention/treatment | Phase |
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HIV AIDS Opioid Dependence Drug Dependence | Drug: Extended-Release Naltrexone | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 151 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Naltrexone for Opioid Dependent Released Human Immunodeficiency Virus Positive (HIV+) Criminal Justice Populations |
Study Start Date : | March 2011 |
Actual Primary Completion Date : | March 2016 |
Actual Study Completion Date : | July 2016 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Extended-Release Naltrexone
Participants will receive intramuscular (IM) injections of Naltrexone once monthly for 6 months, the first injection being prior release
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Drug: Extended-Release Naltrexone
Extended-Release Naltrexone (Vivitrol), once a month by IM injection, for a total of 6 months. Dosage is 380mg
Other Names:
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Placebo Comparator: Placebo
Participants will receive IM injections of Placebo once monthly for 6 months, the first injection being prior release
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Drug: Extended-Release Naltrexone
Extended-Release Naltrexone (Vivitrol), once a month by IM injection, for a total of 6 months. Dosage is 380mg
Other Names:
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- Participants Who Had Undetectable HIV-1 RNA Levels at Less Than 400 Copies/mL at Six Month [ Time Frame: 6 months ]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.
- Particpants Who Had Undetectable HIV-1 RNA Levels at Less Than 50 Copies/mL [ Time Frame: 6 months ]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.
- CD4 Cell Count (Cells/mL) [ Time Frame: Baseline and 6 months ]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.
- Time to Opioid Relapse or End of Intervention [ Time Frame: 6 months ]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.
- Addiction Severity [ Time Frame: baseline, and 6 months ]
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.
- Craving for Opioids [ Time Frame: 6 months ]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.
- Antiretroviral Therapy (ART) Adherence 100% [ Time Frame: 6 months ]Number of subjects with 100% adherence at 6 months measured using Visual Analogue Scale: 0% to 100%
- Participants With Opiate Abstinence Via By Doing Urine Toxicology Test [ Time Frame: 6 month ]Percent of subjects with no opiate use at 6 month. Missing data was treated as failure (opiate positive).
- Opioid Abstinence at 6 Months for Those With More Than 4 Injections [ Time Frame: 6 months ]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.
- ART Adherence for 4 or More Injections XR-NTX Versus Placebo and 3 or Less Injections of XR-NTX [ Time Frame: 6 months ]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.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Meets DSM-IV criteria for opioid dependence
- Age > 18 years
- Confirmed HIV infection, either through positive HIV antibody or detectable HIV-1 RNA level.
- 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.
- No participation in pharmacotherapy trial in the previous 30 days
- Not pregnant
Exclusion Criteria:
- Unable to provide informed consent
- Verbally or physically threatening to research staff
- Unable to communicate in either English or Spanish
- Pending trials for a felony
- Liver failure (Childs-Pugh Class B or C Cirrhosis)
- Grade IV Hepatitis (liver function tests > 10X normal)
- Receiving opioid prescription narcotics or has pain syndrome necessitating future use of opioid prescription narcotics.
- Receiving active methadone or buprenorphine/naloxone for the treatment of opioid dependency
- Active opioid withdrawal (within 3-5 days since last opioid ingestion)
- Pregnancy or unwilling to take contraceptives measures
- Breast-feeding

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01246401
United States, Connecticut | |
Yale University | |
Hartford, Connecticut, United States, 06106 | |
Yale University | |
New Haven, Connecticut, United States, 06519 | |
United States, Massachusetts | |
Baystate Medical Center | |
Springfield, Massachusetts, United States, 01103 |
Principal Investigator: | Sandra A Springer, MD | Yale University | |
Principal Investigator: | Frederick L Altice | Yale University |
Publications of Results:
Other Publications:
Responsible Party: | Yale University |
ClinicalTrials.gov Identifier: | NCT01246401 History of Changes |
Other Study ID Numbers: |
1007007169 |
First Posted: | November 23, 2010 Key Record Dates |
Results First Posted: | July 17, 2017 |
Last Update Posted: | July 17, 2017 |
Last Verified: | June 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Data has been shared with the National Institute on Drug Abuse as a site in the data harmonization project associated with Seek, Test, Treat and Retain for Criminal Justice Populations. |
Additional relevant MeSH terms:
Immunologic Deficiency Syndromes Acquired Immunodeficiency Syndrome HIV Infections Substance-Related Disorders HIV Seropositivity Immune System Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Chemically-Induced Disorders Mental Disorders Naltrexone Narcotic Antagonists Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents |