NCT00348868

Buprenorphine HIV Care Integration Project

Miami Buprenorphine HIV Care Integration Project

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: University of Miami · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• HIV Infection
• Opioid-Related Disorders

Interventions

Type	Name	Description
BEHAVIORAL	enhanced behavioral motivation counseling
BEHAVIORAL	Motivational counseling
BEHAVIORAL	Standard counseling

Timeline

• Start date: 2006-07-01
• Primary completion: 2007-12-01
• Completion: 2007-12-01
• First posted: 2006-07-06
• Last updated: 2008-03-18

Locations

1 site across 1 country: United States