Phase 2 N=93 Randomized Quadruple-blind Treatment

Naltrexone for Opioid Dependent Released Human Immunodeficiency Virus Positive (HIV+) Criminal Justice Populations

HIV · AIDS · Opioid Dependence · Drug Dependence

Bottom Line

View on ClinicalTrials.gov: NCT01246401 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2017

Primary outcome: Primary: Participants Who Had Undetectable HIV-1 RNA Levels at Less Than 400 Copies/mL at Six Month — 45; 16 Participants — p=0.431

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Extended-Release Naltrexone (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Yale University
Primary completion: Mar 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Participants Who Had Undetectable HIV-1 RNA Levels at Less Than 400 Copies/mL at Six Month	45; 16	0.431
SECONDARY Particpants Who Had Undetectable HIV-1 RNA Levels at Less Than 50 Copies/mL	40; 11	0.087
SECONDARY CD4 Cell Count (Cells/mL)	465.2; 580.8; 462; 485.6	—
SECONDARY Time to Opioid Relapse or End of Intervention	137; 29	0.03 sig
SECONDARY Addiction Severity	0.37; 0.42; 0.12; 0.16	—
SECONDARY Craving for Opioids	12; 7; 6; 3; 14; 5	—
SECONDARY Antiretroviral Therapy (ART) Adherence 100%	25; 12	—
SECONDARY Participants With Opiate Abstinence Via By Doing Urine Toxicology Test	44; 17; 13; 5	—
SECONDARY Opioid Abstinence at 6 Months for Those With More Than 4 Injections	18; 13	0.03962 sig
SECONDARY ART Adherence for 4 or More Injections XR-NTX Versus Placebo and 3 or Less Injections of XR-NTX	23; 14	—

Summary

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01246401). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.