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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01550341
First Posted: March 12, 2012
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
George Mason University
Howard University
Information provided by (Responsible Party):
Yale University
June 21, 2011
March 12, 2012
October 12, 2017
April 2012
November 2015   (Final data collection date for primary outcome measure)
  • HIV-1 RNA levels [ Time Frame: baseline ]
    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 ]
    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 ]
    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 ]
    Monitor change in percent Viral Load <400, change in CD4 count, change in retention in care, and change in HIV risk behaviors
Same as current
Complete list of historical versions of study NCT01550341 on ClinicalTrials.gov Archive Site
  • Improved opioid treatment outcomes [ Time Frame: baseline, wk 4, 9, 13, 18, 22, 27, 31, 36, 40, 45, 52 ]
    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 ]
    Measure change in time to reincarceration,number of days reincarcerated, and crime days, between baseline and each monthly follow-up visit.
Same as current
Not Provided
Not Provided
 
HIV, Buprenorphine, and the Criminal Justice System
HIV, Buprenorphine, and the Criminal Justice System
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.
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.
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Human Immunodeficiency Virus
  • Acquired Immunodeficiency Syndrome
  • Opiate Addiction
  • Drug Dependence
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
  • Active Comparator: Buprenorphine
    Intervention: Drug: Buprenorphine/naloxone
  • Placebo Comparator: Placebo
    Intervention: Drug: Buprenorphine/naloxone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
152
June 2017
November 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01550341
1011007631
R01DA030768 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
Yale University
Yale University
  • George Mason University
  • Howard University
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
Yale University
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP