Trial record 4 of 47 for:    " May 25, 2011":" June 24, 2011"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

HIV, Buprenorphine, and the Criminal Justice System (STRIDE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2012 by Yale University
Sponsor:
Collaborators:
George Mason University
Howard University
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT01550341
First received: June 21, 2011
Last updated: April 23, 2012
Last verified: April 2012
  Purpose

Project STRIDE is a placebo-controlled, randomized trial of buprenorphine (BUP) treatment for HIV-infected, community-supervised defendants or offenders (Pre-Trial Services, probation, or Re-entry and Sanction Center) meeting DSM-IV criteria for opioid dependence.


Condition Intervention
Human Immunodeficiency Virus
Acquired Immunodeficiency Syndrome
Opiate Addiction
Drug Dependence
Drug: Buprenorphine/naloxone

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: HIV, Buprenorphine, and the Criminal Justice System

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • HIV-1 RNA levels [ Time Frame: baseline ] [ Designated as safety issue: No ]
    Monitor change in percent Viral Load <400, change in CD4 count, change in retention in care, and change in HIV risk behaviors

  • HIV-1 RNA levels [ Time Frame: week 13 ] [ Designated as safety issue: No ]
    Monitor change in percent Viral Load <400, change in CD4 count, change in retention in care, and change in HIV risk behaviors

  • HIV-1 RNA levels [ Time Frame: week 27 ] [ Designated as safety issue: No ]
    Monitor change in percent Viral Load <400, change in CD4 count, change in retention in care, and change in HIV risk behaviors

  • HIV-1 RNA levels [ Time Frame: week 40 ] [ Designated as safety issue: No ]
    Monitor change in percent Viral Load <400, change in CD4 count, change in retention in care, and change in HIV risk behaviors


Secondary Outcome Measures:
  • Improved opioid treatment outcomes [ Time Frame: baseline, wk 4, 9, 13, 18, 22, 27, 31, 36, 40, 45, 52 ] [ Designated as safety issue: No ]
    Monitor relapse to opioid use, retention on Buprenorphine or placebo, percent days using opioids, lower addiction severity, lower craving, between baseline and subsequent follow-up visits. Monitor urine toxicology screens on every visit for approximately one year.

  • Improved criminal justice outcomes [ Time Frame: baseline, wk 4, 9, 13, 18, 22, 27, 31, 36, 40, 45, 49, 52 ] [ Designated as safety issue: No ]
    Measure change in time to reincarceration,number of days reincarcerated, and crime days, between baseline and each monthly follow-up visit.


Estimated Enrollment: 152
Study Start Date: April 2012
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Buprenorphine Drug: Buprenorphine/naloxone
2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration.
Other Name: Suboxone
Placebo Comparator: Placebo Drug: Buprenorphine/naloxone
2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration.
Other Name: Suboxone

Detailed Description:

The purpose of this study is to determine whether treatment with BUP will help to reduce opioid dependence in HIV + inmates and improve their health outcomes with regard to substance dependence and HIV, as well as reduce their criminal justice involvement. In this study, which will take place in Washington D.C., we will examine whether among HIV+ opioid dependent prisoners, undergoing treatment with BUP will result in improved HIV-related outcomes (VL, CD4, retention in care, HIV risk behaviors), improved opioid treatment outcomes (relapse to opioid use, retention on BUP or placebo, percent days using opioids, lower addiction severity, lower craving), and improved criminal justice outcomes (time to reincarceration, number of days reincarcerated, crime days) over the following 12 months. In order to determine if BUP is effective in altering in these outcomes, we will follow all participants and schedule regular interviews to understand their progress in treatment. This will also enable us to look at the opioid use in the subject's system and the amount of virus in the participant's blood, and conduct other tests such as liver function tests to monitor for adverse side effects.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HIV+
  • Age ≥18 yrs
  • Individuals under community supervision, including being under pre-trial supervision or probation
  • Meets DSM-IV criteria for opioid dependence
  • Has medical entitlements in DC
  • Able to provide informed consent
  • Able to communicate in English or Spanish

Exclusion Criteria:

  • Being prescribed an opiate medication for a chronic pain condition or expressing the need to be placed on chronic pain medical conditions for a documented pain condition
  • Currently receiving methadone dosing of over 30 mg per day and uninterested in changing to buprenorphine
  • AST and ALT >5x the upper limit of normal (AST≥175, ALT≥195)
  • Pregnant or unwilling to use contraception (including OCPs, patch, Depo-Provera, condoms, etc.)
  • Breastfeeding or unwilling to stop breastfeeding
  • Subject is part of another pharmacological research study
  • Liver dysfunction (acute hepatitis, liver failure or hepatic dysfunction)
  • Suicidal ideation
  • Hypersensitivity to buprenorphine
  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: NCT01550341

Contacts
Contact: Ruthanne Marcus, MPH 203-764-9958 ruthanne.marcus@yale.edu
Contact: Amy Murphy, MS 703-993-5222 amurph10@gmu.edu

Locations
United States, District of Columbia
Howard University Recruiting
Washington, District of Columbia, United States, 20060
Contact: Jesus Felizzola, MD, MHSA, MA    202-865-1480    JFelizzola@Howard.edu   
Principal Investigator: William Lawson, MD         
Sponsors and Collaborators
Yale University
George Mason University
Howard University
Investigators
Principal Investigator: Frederick Altice, MD Yale University School of Medicine/AIDS Program
Principal Investigator: Faye Taxman, PhD George Mason University
Principal Investigator: William Lawson, MD Howard University
  More Information

No publications provided

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01550341     History of Changes
Other Study ID Numbers: 1011007631
Study First Received: June 21, 2011
Last Updated: April 23, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
HIV
AIDS
Opiate Addiction
Drug Dependence
Buprenorphine

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Substance-Related Disorders
Behavior, Addictive
Opioid-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
Compulsive Behavior
Impulsive Behavior
Buprenorphine
Naloxone
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotic Antagonists
Narcotics

ClinicalTrials.gov processed this record on July 23, 2014