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Buprenorphine HIV Care Integration Project

This study has been completed.
Sponsor:
Collaborators:
HRSA/Maternal and Child Health Bureau
National Institute on Drug Abuse (NIDA)
Information provided by:
University of Miami
ClinicalTrials.gov Identifier:
NCT00348868
First received: July 5, 2006
Last updated: March 14, 2008
Last verified: April 2007
History of Changes
  Purpose

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.


Condition Intervention
HIV Infection
Opioid-Related Disorders
 Behavioral: enhanced behavioral motivation counseling
Behavioral: Motivational counseling
Behavioral: Standard counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Miami Buprenorphine HIV Care Integration Project

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by University of Miami:

Primary Outcome Measures:
  • 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 ]

Enrollment: 10
Study Start Date: July 2006
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
enhanced behavioral motivation counseling
 Behavioral: enhanced behavioral motivation counseling Behavioral: Motivational counseling
Active Comparator: 2 Behavioral: Standard counseling

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00348868

Locations
United States, Florida
University of Miami AIDS Clinical Reserach Unit
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
HRSA/Maternal and Child Health Bureau
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Margaret Fischl, M.D. University of Miami
  More Information

No publications provided

Responsible Party: Margaret A. Fischl, M.D., Unversity of Miami
ClinicalTrials.gov Identifier: NCT00348868     History of Changes
Other Study ID Numbers: A007
Study First Received: July 5, 2006
Last Updated: March 14, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of Miami:
HIV Infection
Opioid dependence
DSM-IV criteria for opioid dependence

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Opioid-Related Disorders
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Substance-Related Disorders
 Mental Disorders
Buprenorphine
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotic Antagonists
Narcotics

ClinicalTrials.gov processed this record on June 18, 2013