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

NCT01246401 | Completed Phase 1 Results DMC

• 2 other identifiers: 10070071691K02DA032322-01
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

HIV; AIDS; Opioid Dependence; Drug Dependence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Particpants Who Had Undetectable HIV-1 RNA Levels at Less Than 50 Copies/mL

  6 months

• CD4 Cell Count (Cells/mL)

  Baseline and 6 months

• Time to Opioid Relapse or End of Intervention

  6 months

• Addiction Severity

  baseline, and 6 months

• Craving for Opioids

  6 months

Study Arms (2)

Extended-Release Naltrexone

ACTIVE COMPARATOR

Participants will receive intramuscular (IM) injections of Naltrexone once monthly for 6 months, the first injection being prior release

Drug: Extended-Release Naltrexone

Placebo

PLACEBO COMPARATOR

Participants will receive IM injections of Placebo once monthly for 6 months, the first injection being prior release

Drug: Extended-Release Naltrexone

Interventions

Extended-Release Naltrexone DRUG

Extended-Release Naltrexone (Vivitrol), once a month by IM injection, for a total of 6 months. Dosage is 380mg

Also known as: Naltrexone, depot, Vivitrol

Extended-Release Naltrexone; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• Baystate Medical Center: collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (3)

Yale University

Hartford, Connecticut, 06106, United States

Location

Yale University

New Haven, Connecticut, 06519, United States

Location

Baystate Medical Center

Springfield, Massachusetts, 01103, United States

Location

Related Publications (5)

• 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.

  PMID: 25240704 BACKGROUND

• 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 Abuse Treat. 2014 Jul;47(1):35-40. doi: 10.1016/j.jsat.2014.02.008. Epub 2014 Mar 12.

  PMID: 24674234 RESULT

• 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: 10.1016/j.drugalcdep.2015.10.023. Epub 2015 Oct 28.

  PMID: 26560326 RESULT

• Kornor H, Lobmaier PPK, Kunoe N. Sustained-release naltrexone for opioid dependence. Cochrane Database Syst Rev. 2025 May 9;5(5):CD006140. doi: 10.1002/14651858.CD006140.pub3.

  PMID: 40342086 DERIVED

• Springer SA, Di Paola A, Azar MM, Barbour R, Biondi BE, Desabrais M, Lincoln T, Skiest DJ, Altice FL. Extended-Release Naltrexone Improves Viral Suppression Among Incarcerated Persons Living With HIV With Opioid Use Disorders Transitioning to the Community: Results of a Double-Blind, Placebo-Controlled Randomized Trial. J Acquir Immune Defic Syndr. 2018 May 1;78(1):43-53. doi: 10.1097/QAI.0000000000001634.

  PMID: 29373393 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Opioid-Related Disorders; Substance-Related Disorders

Interventions

Naltrexone; vivitrol

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Narcotic-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Dr. Sandra Springer
• Organization: Yale University

sandra.springer@yale.edu

Study Officials

• Sandra A Springer, MD

  Yale University

  PRINCIPAL INVESTIGATOR

• Frederick L Altice

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2010
• First Posted: November 23, 2010
• Study Start: March 1, 2011
• Primary Completion: March 1, 2016
• Study Completion: July 1, 2016
• Last Updated: March 19, 2020
• Results First Posted: July 17, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will share

Locations

US (3)