Buprenorphine HIV Care Integration Project

University of Miami10 enrolled

Overview

A007 is a randomized, two-arm study evaluating the effectiveness of standard drug addiction counseling with buprenorphine/naloxone to enhanced motivational drug counseling with buprenorphine/naloxone for the treatment for opioid addiction in an integrated and nonintegrated HIV care setting.

DESIGN: A007 is a randomized, two-arm study evaluating the effectiveness of standard drug addiction counseling with buprenorphine/naloxone to enhanced motivational drug counseling with buprenorphine/naloxone for the treatment for opioid addiction in an integrated and nonintegrated HIV care setting. DURATION: Subjects will participate in this study for approximately 48 weeks. Chart abstractions will continue for up to four years. SAMPLE SIZE: This study will enroll 60 subjects (30 per arm) over 72 weeks. POPULATION: HIV-1 infected opioid dependent men and women ≥18 years of age who initiate buprenorphine for the treatment of opioid dependence and who are receiving primary care for HIV-1 infection. STRATIFICATION: Subjects will be stratified at screening based on HIV care setting (integrated HIV care vs. nonintegrated HIV care) INTERVENTON At entry subjects will be randomized to one of the following: ARM A: Standard drug addiction counseling + buprenorphine / naloxone ARM B: Enhanced behavioral motivation counseling + buprenorphine / naloxone The three primary outcomes are: 1. Cessation of illicit opioid use 2. Reduction in high risk behavior 3. Improved HIV therapy adherence

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

HIV Infection Opioid-Related Disorders

Interventions

enhanced behavioral motivation counselingBEHAVIORAL

Motivational counselingBEHAVIORAL

Standard counselingBEHAVIORAL

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * HIV infection * Receiving or seeking outpatient HIV care * Seeking outpatient treatment for opioid dependence and be willing to take buprenorphine * Meets DSM-IV criteria for opioid dependence, and be willing to stop illicit opioid use and be experiencing early symptoms of opioid withdrawal at the time that buprenorphine is given * Men and women age ≥ 18 years * Women of reproductive potential must have a negative serum or urine pregnancy test result available within 7 days prior to initiating buprenorphine * Within 30 days: (SGOT), ALT (SGPT), and alkaline phosphatase \<=5 X ULN, Total bilirubin \<= 2.5 x ULN Exclusion Criteria: * Serious medical problem * Acute and/or severe psychiatric conditions * High dose methadone (\>30 mg/day) * Documented co-dependence on alcohol and/or benzodiazepines, barbiturates * Chronic pain management requiring opioids * Pregnancy or breast-feeding * Imprisonment or involuntary incarceration in a medical facility for psychiatric or physical

Locations (1)

University of Miami AIDS Clinical Reserach Unit

Miami, Florida, United States

Outcomes

Primary Outcomes

The three primary outcomes are Cessation of illicit opioid use, Reduction in high risk behavior and Improved HIV therapy adherence

Time frame: week 48

Data from ClinicalTrials.gov

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