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OpenTrials
Completed

NCT Number: NCT01550341

HIV, Buprenorphine, and the Criminal Justice System

The aims of STRIDE were changed as of July, 2014. The revised project, called STRIDE2, has a longitudinal, non-randomized, observational study design. The population under study consists of individuals living with HIV who are dependent on opioids.

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Key information

About this study

Presented in the results section are the summary of outcomes from the STRIDE RCT that were collected prior to the change in study design. The STRIDE study became STRIDE2 (NCT03583138). 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

buprenorphine/naloxone

Drug

2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration.

Other names: Suboxone

Placebo oral tablet

Drug

2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration.

Primary outcomes

  1. CD4 Count Absolute

    Time frame: Baseline

    CD4 Count Absolute

  2. CD4 Count Absolute

    Time frame: 6 Months

    CD4 Count Absolute

  3. CD4 Count Absolute

    Time frame: 12 Months

    CD4 Count

  4. CD4 Percent

    Time frame: Baseline

    CD4 Percent

  5. CD4 Percent

    Time frame: 6 Months

    CD4 Percent

  6. CD4 Percent

    Time frame: 12 Months

    CD4 Percent

  7. Viral Load

    Time frame: Baseline

    Viral Load

  8. Viral Load

    Time frame: 6 Months

    Viral Load

  9. Viral Load

    Time frame: 12 Months

    Viral Load

  10. Log Viral Load

    Time frame: Baseline

    Log Viral Load

  11. Log Viral Load

    Time frame: 6 Months

    Log Viral Load

  12. Log Viral Load

    Time frame: 12 Months

    Log Viral Load

Secondary outcomes

  1. Improved Opioid Treatment Outcomes

    Time frame: baseline, 3 months, 9 months, 12 months

    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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • George Mason University
  • Howard University
  • National Institute on Drug Abuse (NIDA)

Registry information

Acronym: STRIDE

Important dates

Study start
2012
Primary completion
2015
Study completion
2016
First posted
Mar 12, 2012
Registry last updated
May 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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