HIV, Buprenorphine, and the Criminal Justice System

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-23

Study Completion Date

2016-11-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Human Immunodeficiency Virus Acquired Immunodeficiency Syndrome Opiate Addiction Drug Dependence

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Buprenorphine

Group Type ACTIVE_COMPARATOR

Buprenorphine/naloxone

Intervention Type DRUG

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

Placebo

Group Type PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type DRUG

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

Interventions

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Buprenorphine/naloxone

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

Intervention Type DRUG

Placebo Oral Tablet

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

Intervention Type DRUG

Other Intervention Names

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Suboxone

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No