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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 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: August 18, 2014
Last verified: August 2014
  Purpose

As of July, 2014 the study aims have changed. The revised project, called STRIDE2, is a longitudinal, non-randomized, observational study of individuals living with HIV who are dependent on opioids. This study is funded by the National Institute on Drug Abuse (R01DA030768, Altice, PI; Taxman & Lawson, Co-PIs) and is being conducted by George Mason University, Yale University, and Howard University. Those individuals originally enrolled in the STRIDE RCT will be followed for 12 months.


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:

STRIDE2 will assist in identifying and monitoring individuals' HIV risk behaviors and provide resources to seek treatment for their HIV care and substance use. The goal of STRIDE2 is to examine if there are differences in HIV, drug use, and other outcomes between individuals receiving treatment versus individuals actively using, not actively using and not in treatment, and individuals on Methadone, Suboxone, or in some other treatment.

  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
  • 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: William Lawson, MD, PhD       WBLawson@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: August 18, 2014
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
Immune System Diseases
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Buprenorphine
Naloxone
Analgesics
Analgesics, Opioid
Central Nervous System Agents
Central Nervous System Depressants
Narcotic Antagonists
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014