Clinical trial NCT00348868: Buprenorphine HIV Care Integration Project
Official title: Miami Buprenorphine HIV Care Integration Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infection
Opioid-Related Disorders
Keywords: HIV Infection
Opioid dependence
DSM-IV criteria for opioid dependence
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: HRSA/Maternal and Child Health Bureau
name: National Institute on Drug Abuse (NIDA)
First posted: 2006-07-06
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: The three primary outcomes are Cessation of illicit opioid use, Reduction in high risk behavior and Improved HIV therapy adherence
timeFrame: week 48
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami AIDS Clinical Reserach Unit
state: Florida
Study officials:
affiliation: University of Miami
name: Margaret Fischl, M.D.
role: PRINCIPAL_INVESTIGATOR
References: