Overview

This trial is active, not recruiting.

Conditions human immunodeficiency virus, acquired immunodeficiency syndrome, opiate addiction, drug dependence
Treatment buprenorphine/naloxone
Sponsor Yale University
Collaborator George Mason University
Start date April 2012
End date November 2015
Trial size 152 participants
Trial identifier NCT01550341, 1011007631, R01DA030768

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
buprenorphine/naloxone Suboxone
2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration.
(Placebo Comparator)
buprenorphine/naloxone Suboxone
2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration.

Primary Outcomes

Measure
HIV-1 RNA levels
time frame: baseline
HIV-1 RNA levels
time frame: week 13
HIV-1 RNA levels
time frame: week 27
HIV-1 RNA levels
time frame: week 40

Secondary Outcomes

Measure
Improved opioid treatment outcomes
time frame: baseline, wk 4, 9, 13, 18, 22, 27, 31, 36, 40, 45, 52
Improved criminal justice outcomes
time frame: baseline, wk 4, 9, 13, 18, 22, 27, 31, 36, 40, 45, 49, 52

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title HIV, Buprenorphine, and the Criminal Justice System
Principal investigator Frederick Altice, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Yale University.