Buprenorphine HIV Care Integration Project

This study has been completed.
Sponsor:
Collaborators:
HRSA/Maternal and Child Health Bureau
Information provided by:
University of Miami
ClinicalTrials.gov Identifier:
NCT00348868
First received: July 5, 2006
Last updated: March 14, 2008
Last verified: April 2007

July 5, 2006
March 14, 2008
July 2006
December 2007   (final data collection date for primary outcome measure)
The three primary outcomes are Cessation of illicit opioid use, Reduction in high risk behavior and Improved HIV therapy adherence [ Time Frame: week 48 ] [ Designated as safety issue: No ]
The three primary outcomes are Cessation of illicit opioid use, Reduction in high risk behavior and Improved HIV therapy adherence
Complete list of historical versions of study NCT00348868 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Buprenorphine HIV Care Integration Project
Miami Buprenorphine HIV Care Integration Project

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.

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
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • HIV Infection
  • Opioid-Related Disorders
  • Behavioral: enhanced behavioral motivation counseling
  • Behavioral: Motivational counseling
  • Behavioral: Standard counseling
  • Experimental: 1
    enhanced behavioral motivation counseling
    Interventions:
    • Behavioral: enhanced behavioral motivation counseling
    • Behavioral: Motivational counseling
  • Active Comparator: 2
    Intervention: Behavioral: Standard counseling
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
December 2007
December 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00348868
A007
No
Margaret A. Fischl, M.D., Unversity of Miami
University of Miami
  • HRSA/Maternal and Child Health Bureau
  • National Institute on Drug Abuse (NIDA)
Principal Investigator: Margaret Fischl, M.D. University of Miami
University of Miami
April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP