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

Primary Purpose

Human Immunodeficiency Virus, Acquired Immunodeficiency Syndrome, Opiate Addiction

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Buprenorphine/naloxone
Placebo Oral Tablet
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Human Immunodeficiency Virus focused on measuring HIV, AIDS, Opiate Addiction, Drug Dependence, Buprenorphine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Howard University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Buprenorphine

Placebo

Arm Description

Outcomes

Primary Outcome Measures

CD4 Count Absolute
CD4 Count Absolute
CD4 Count Absolute
CD4 Count Absolute
CD4 Count Absolute
CD4 Count
CD4 Percent
CD4 Percent
CD4 Percent
CD4 Percent
CD4 Percent
CD4 Percent
Viral Load
Viral Load
Viral Load
Viral Load
Viral Load
Viral Load
Log Viral Load
Log Viral Load
Log Viral Load
Log Viral Load
Log Viral Load
Log Viral Load

Secondary Outcome Measures

Improved Opioid Treatment Outcomes
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
Measure change in time to reincarceration,number of days reincarcerated, and crime days, between baseline and each monthly follow-up visit.

Full Information

First Posted
June 21, 2011
Last Updated
April 27, 2020
Sponsor
Yale University
Collaborators
George Mason University, Howard University, National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT01550341
Brief Title
HIV, Buprenorphine, and the Criminal Justice System
Acronym
STRIDE
Official Title
HIV, Buprenorphine, and the Criminal Justice System
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
February 23, 2012 (Actual)
Primary Completion Date
November 30, 2015 (Actual)
Study Completion Date
November 30, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
George Mason University, Howard University, National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Immunodeficiency Virus, Acquired Immunodeficiency Syndrome, Opiate Addiction, Drug Dependence
Keywords
HIV, AIDS, Opiate Addiction, Drug Dependence, Buprenorphine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Buprenorphine
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Buprenorphine/naloxone
Other Intervention Name(s)
Suboxone
Intervention Description
2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration.
Intervention Type
Drug
Intervention Name(s)
Placebo Oral Tablet
Intervention Description
2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration.
Primary Outcome Measure Information:
Title
CD4 Count Absolute
Description
CD4 Count Absolute
Time Frame
Baseline
Title
CD4 Count Absolute
Description
CD4 Count Absolute
Time Frame
6 Months
Title
CD4 Count Absolute
Description
CD4 Count
Time Frame
12 Months
Title
CD4 Percent
Description
CD4 Percent
Time Frame
Baseline
Title
CD4 Percent
Description
CD4 Percent
Time Frame
6 Months
Title
CD4 Percent
Description
CD4 Percent
Time Frame
12 Months
Title
Viral Load
Description
Viral Load
Time Frame
Baseline
Title
Viral Load
Description
Viral Load
Time Frame
6 Months
Title
Viral Load
Description
Viral Load
Time Frame
12 Months
Title
Log Viral Load
Description
Log Viral Load
Time Frame
Baseline
Title
Log Viral Load
Description
Log Viral Load
Time Frame
6 Months
Title
Log Viral Load
Description
Log Viral Load
Time Frame
12 Months
Secondary Outcome Measure Information:
Title
Improved Opioid Treatment Outcomes
Description
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.
Time Frame
baseline, 3 months, 9 months, 12 months
Title
Improved Criminal Justice Outcomes
Description
Measure change in time to reincarceration,number of days reincarcerated, and crime days, between baseline and each monthly follow-up visit.
Time Frame
baseline, wk 4, 9, 13, 18, 22, 27, 31, 36, 40, 45, 49, 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederick Altice, MD
Organizational Affiliation
Yale University School of Medicine/AIDS Program
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Faye Taxman, PhD
Organizational Affiliation
George Mason University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
William Lawson, MD
Organizational Affiliation
Howard University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Howard University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20060
Country
United States

12. IPD Sharing Statement

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HIV, Buprenorphine, and the Criminal Justice System

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