This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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

This study has been completed.
Sponsor:
Collaborator:
Baystate Medical Center
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT01246401
First received: November 22, 2010
Last updated: June 14, 2017
Last verified: June 2017
  Purpose

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 Intervention Phase
HIV AIDS Opioid Dependence Drug Dependence Drug: Extended-Release Naltrexone Phase 1 Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 151
Study Start Date: March 2011
Study Completion Date: July 2016
Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Extended-Release Naltrexone
Participants will receive intramuscular (IM) injections of Naltrexone once monthly for 6 months, the first injection being prior release
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:
  • Naltrexone, depot
  • Vivitrol
Placebo Comparator: Placebo
Participants will receive IM injections of Placebo once monthly for 6 months, the first injection being prior release
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:
  • Naltrexone, depot
  • Vivitrol

Detailed Description:
The specific aim for this study is to conduct a placebo-controlled trail (RCT) of XR-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 XR-NTX or 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 XR-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   (Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
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
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

Publications:
Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01246401     History of Changes
Other Study ID Numbers: 1007007169
Study First Received: November 22, 2010
Results First Received: February 27, 2017
Last Updated: June 14, 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:
Acquired Immunodeficiency Syndrome
HIV Infections
HIV Seropositivity
Immunologic Deficiency Syndromes
Substance-Related Disorders
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

ClinicalTrials.gov processed this record on August 18, 2017