Buprenorphine HIV Care Integration Project - Full Text View

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

MedlinePlus related topics:

AIDS

ChemIDplus related topics:

Buprenorphine Buprenorphine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Official Title:	Miami Buprenorphine HIV Care Integration Project

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
1: Experimental enhanced behavioral motivation counseling	Behavioral: enhanced behavioral motivation counseling Behavioral: Motivational counseling
2: Active Comparator	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:

Cessation of illicit opioid use
Reduction in high risk behavior
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

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

Keywords provided by University of Miami:

HIV Infection

Opioid dependence

DSM-IV criteria for opioid dependence

Study placed in the following topic categories:

Virus Diseases

Buprenorphine

Sexually Transmitted Diseases, Viral

Mental Disorders

HIV Infections

Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome

Substance-Related Disorders

Disorders of Environmental Origin

Opioid-Related Disorders

Retroviridae Infections

Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

RNA Virus Infections

Slow Virus Diseases

Immune System Diseases

Narcotic Antagonists

Physiological Effects of Drugs

Central Nervous System Depressants

Narcotics

Infection

Pharmacologic Actions

Sensory System Agents

Therapeutic Uses

Lentivirus Infections

Analgesics

Peripheral Nervous System Agents

Central Nervous System Agents

Analgesics, Opioid

ClinicalTrials.gov processed this record on September 05, 2008

Sponsors and Collaborators:	University of Miami HRSA/Maternal and Child Health Bureau National Institute on Drug Abuse (NIDA)
Information provided by:	University of Miami
ClinicalTrials.gov Identifier:	NCT00348868