Buprenorphine HIV Care Integration Project

Not Applicable

Completed

• Conditions: HIV Infection; Opioid-Related Disorders
• Interventions: Behavioral: enhanced behavioral motivation counseling; Behavioral: Standard counseling; Behavioral: Motivational counseling

• Registration Number: NCT00348868
• Lead Sponsor: University of Miami

Brief 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

Study Timeline

• Study Start: 2006-07
• Study First Submitted: 2006-07-05
• Study First Submitted QC: 2006-07-05
• Study First Posted: 2006-07-06
• Status Verified: 2007-04
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Last Update Submitted: 2008-03-14
• Last Update Posted: 2008-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	enhanced behavioral motivation counseling	enhanced behavioral motivation counseling
1	Motivational counseling	enhanced behavioral motivation counseling
2	Standard counseling	-

Primary Outcome Measures

Name	Time	Method
The three primary outcomes are Cessation of illicit opioid use, Reduction in high risk behavior and Improved HIV therapy adherence	week 48

Trial Locations

Locations (1)

University of Miami AIDS Clinical Reserach Unit; 🇺🇸 Miami, Florida, United States