Buprenorphine HIV Care Integration Project

Miami Buprenorphine HIV Care Integration Project

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00348868

Enrollment

Registered

2006-07-06

Start date

2006-07-31

Completion date

2007-12-31

Last updated

2008-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infection, Opioid-Related Disorders

Keywords

HIV Infection, Opioid dependence, DSM-IV criteria for opioid dependence

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

Interventions

BEHAVIORALenhanced behavioral motivation counseling

BEHAVIORALMotivational counseling

BEHAVIORALStandard counseling

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026