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

This study is currently recruiting participants.
Verified August 2011 by Yale University
Sponsor:
Collaborator:
Baystate Medical Center
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT01246401
First received: November 22, 2010
Last updated: August 4, 2011
Last verified: August 2011
  Purpose

Specific Aim: To conduct a randomized, placebo-controlled trial of depot-naltrexone (d-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. d-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. d-NTX will result in improved opioid treatment outcomes, including longer time to opioid relapse, lower addiction severity and lower craving for opioid.

iii. d-NTX will result in reduced drug- and sex-related HIV risk behaviors compared to the control group.

iv. d-NTX will result in decreased rates of reincarceration after 12 months of release to the community.


Condition Intervention Phase
HIV
AIDS
Opioid Dependence
Drug Dependence
Drug: Depot Naltrexone
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Naltrexone for Opioid Dependent Released Human Immunodeficiency Virus Positive (HIV+) Criminal Justice Populations

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • HIV-1 RNA levels (copies/mL) [ Time Frame: At baseline and every 3 months for 1 year ] [ Designated as safety issue: No ]
    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.

  • CD4 cell count (cells/mL) [ Time Frame: Baseline and every 3 months for 1 year ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • time to opioid relapse [ Time Frame: baseline, months 3, 6, 9, and 12 ] [ Designated as safety issue: No ]
  • addiction severity [ Time Frame: baseline, months 3, 6, 9 and 12 months ] [ Designated as safety issue: No ]
    The Addiciton Severity Index questionnaire will be used to assess addiction severity

  • Craving for opioids [ Time Frame: baseline then every month until 12 months after release ] [ Designated as safety issue: No ]
    Done using Visual Analog Scale


Estimated Enrollment: 150
Study Start Date: March 2011
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Naltrexone
Participants will receive intramuscular (IM) injections of Naltrexone once monthly for 6 months, the first injection being prior release
Drug: Depot Naltrexone
Depot Naltrexone (Vivitrol), once a month by IM injection, for a total of 6 months. Dosage is 380mg
Other Names:
  • Naltrexone, depot
  • Vivitrol
  • Extended-release Naltrexone
Placebo Comparator: Placebo
Participants will receive IM injections of Placebo once monthly for 6 months, the first injection being prior release
Drug: Depot Naltrexone
Depot Naltrexone (Vivitrol), once a month by IM injection, for a total of 6 months. Dosage is 380mg
Other Names:
  • Naltrexone, depot
  • Vivitrol
  • Extended-release Naltrexone

Detailed Description:

The specific aim for this study is to conduct a placebo-controlled trail (RCT) of d-NTX among HIV+ persons in jails and prisons meeting DSM-IV criteria for opioid dependence who are transitioning to the community. HIV treatment outcomes (HIV-1 RNA levels, CD4 count, Highly Active Antiretroviral Therapy(HAART) adherence, retention in care), substance abuse (time to relapse to opioid use, % opioid negative urines, opioid craving), adverse side effects and HIV risk behavior (sexual and drug-related risks) outcomes will be compared in 150 recruited prisoners and jail detainees in Connecticut (CT) and Massachusetts (MA) who will be randomized 2:1 to either d-NTX or depot-placebo. The primary outcome of interest will be the proportion with a HIV-RNA <400 copies/mL at 6 months. Secondary outcomes include mean CD4 count, antiretroviral adherence, retention on HAART and in HIV care, HIV risk behaviors, time-to-relapse to opioid use, percent opioid negative urines, retention on d-NTX and HIV quality of life. Primary and secondary outcomes will be assessed for an additional 6 months after completion of the intervention. If this placebo-controlled trial of d-NTX among released HIV+ criminal justice system (CJS) persons with opioid dependence demonstrates efficacy and safety, it is likely to become an evidence-based intervention to intervene with this extremely marginalized population in a way that will meet Healthy People 2010's goals to increase the quality and years of life, decrease health disparities particularly among minorities, break the cycle of addiction, reduce the numbers of people within the CJS and launch a number of new and innovative trials and second generation questions for future research. As such, the individual, our health care system and society have a high likelihood to benefit. This will not only be true for strategies here in the U.S., but may have even greater application for geographic areas where the interface between opioid disorders and HIV is even greater.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01246401

Contacts
Contact: Angela DiPaola, MS 2037375530 angela.dipaola@yale.edu
Contact: Ruthanne Marcus 2037649958 ruthanne.marcus@yale.edu

Locations
United States, Connecticut
Yale University Recruiting
Hartford, Connecticut, United States, 06106
Contact: Angela DiPaola, MS    203-737-5530    angela.dipaola@yale.edu   
Principal Investigator: Sandra A Springer, MD         
Yale University Recruiting
New Haven, Connecticut, United States, 06519
Contact: Angela DiPaola, MS    203-737-5530    angela.dipaola@yale.edu   
Principal Investigator: Sandra A Springer, MD         
United States, Massachusetts
Baystate Medical Center Not yet recruiting
Springfield, Massachusetts, United States, 01103
Contact: Maureen Desabrais    413-858-0396    maureen.desabrais@baystatehealth.org   
Principal Investigator: Daniel Skiest, MD         
Sponsors and Collaborators
Yale University
Baystate Medical Center
Investigators
Principal Investigator: Sandra A Springer, MD Yale University
Principal Investigator: Frederick L Altice Yale University
  More Information

No publications provided

Responsible Party: Sandra A. Springer, Assistant Professor of Medicine, Yale University, School of Medicine
ClinicalTrials.gov Identifier: NCT01246401     History of Changes
Other Study ID Numbers: 1007007169
Study First Received: November 22, 2010
Last Updated: August 4, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Opioid-Related Disorders
Acquired Immunodeficiency Syndrome
HIV Infections
HIV Seropositivity
Immunologic Deficiency Syndromes
Substance-Related Disorders
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases
Mental Disorders
Naltrexone
Analgesics, Opioid
Narcotic Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Analgesics
Central Nervous System Depressants

ClinicalTrials.gov processed this record on April 16, 2014