Buprenorphine HIV Care Integration Project

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:

• Cessation of illicit opioid use
• Reduction in high risk behavior
• Improved HIV therapy adherence

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