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

Yale University

Status: Completed

Conditions: Drug Dependence; Human Immunodeficiency Virus; Opiate Addiction; Acquired Immunodeficiency Syndrome

Treatments: Drug: Placebo Oral Tablet; Drug: Buprenorphine/naloxone

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01550341

1011007631

R01DA030768 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups, including a placebo group

Buprenorphine

Active Comparator group

Treatment:

Drug: Buprenorphine/naloxone

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo Oral Tablet