Integration of Buprenorphine Into HIV Clinical Settings - Primary Care Model (PCM) - Full Text View

Sponsor:	Yale University
Collaborators:	Waterbury Hospital Health Resources and Services Administration (HRSA) The New York Academy of Medicine
Information provided by:	Yale University
ClinicalTrials.gov Identifier:	NCT00798538

Purpose

The purpose of this study is to assess the feasibility, cost and effectiveness of interventions designed to integrate buprenorphine treatment for opioid dependence into HIV primary care in ten HIV care centers in the U.S.

In the site led by Dr. Altice, we compare two models of providing HIV care and buprenorphine treatment. Assignments are based on participants' city of residence. In the onsite (integrated care) model, participants receive buprenorphine, substance abuse counseling and HIV care at one location: the Waterbury Hospital Infectious Disease Clinic. In the off-site model (non-integrated care) buprenorphine induction, substance abuse counseling, and HIV care will be provided at separate locations: the Community Health Care Van (CHCV), the Yale AIDS Program, and patients' own HIV providers, respectively. Data is collected from interviews with participants, reviews of medical records, and surveys and interviews with clinicians.

Condition	Intervention	Phase
Buprenorphine HIV Drug Abuse Drug Addiction Drug Dependence Drug Use Disorders Drug Use Disorder Substance Abuse Opiate Addiction Substance-Related Disorders	Other: Services will be provided at one site Other: Services remain dispersed; i.e., not centralized to one-location or provider.	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Health Services Research
Official Title:	Integration of Buprenorphine Into HIV Clinical Settings - Primary Care Model (PCM)

Resource links provided by NLM:

MedlinePlus related topics: Drug Abuse HIV/AIDS

Drug Information available for: Buprenorphine Buprenorphine hydrochloride

U.S. FDA Resources

Further study details as provided by Yale University:

Primary Outcome Measures:

Substance use outcomes measured by self-report [ Time Frame: at 1, 3, 6, 9 and 12 months measured by self-report ] [ Designated as safety issue: No ]
Urine toxicology results [ Time Frame: at 1, 3, 6, 9 and 12 months ] [ Designated as safety issue: No ]
Retention in and adherence to HIV care [ Time Frame: at 1, 3, 6, 9 and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Quality of life [ Time Frame: at 1, 3, 6, 9, and 12 months ] [ Designated as safety issue: No ]
HIV-related health outcomes [ Time Frame: at 1, 3, 6, 9, and 12 months ] [ Designated as safety issue: No ]

Enrollment:	60
Study Start Date:	August 2005
Estimated Study Completion Date:	August 2010
Estimated Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Integrated Provision of buprenorphine induction and management, substance abuse counseling and HIV care at one clinic.	Other: Services will be provided at one site Provision of buprenorphine induction and management, substance abuse counseling and HIV care will be provided at one clinic: the Waterbury Hospital Infectious Disease Clinic..
Placebo Comparator: Non-integrated Buprenorphine induction, substance abuse counseling and HIV care will be managed at multiple locations, respectively: the Community Health Care Van, the Yale AIDS Program, and individuals' HIV clinics.	Other: Services remain dispersed; i.e., not centralized to one-location or provider. Buprenorphine induction, substance abuse counseling, and HIV care will be provided at separate locations: the Community Health Care Van (CHCV), the Yale AIDS Program, and patients' own HIV providers, respectively.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

HIV-infected
Clinical diagnosis of opioid dependence
Fluent in English or Spanish
18 years or older

Exclusion Criteria:

Liver function tests (transaminase only) at five times or higher than normal level;
Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (DSM-IV) criteria for benzodiazepine abuse or dependence within the past 6 months;
DSM-IV criteria for alcohol dependence within the past 6 months;
Actively suicidal;
Psychiatric impairment that impedes ability to consent (dementia, delusional, actively psychotic);
Methadone dose exceeding levels allowing for safe transition to buprenorphine;
Pregnant women and women actively trying to become pregnant;
Clinical judgment of local site principal investigator that patient is inappropriate

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00798538

Locations

United States, Connecticut
Yale AIDS Program
New Haven, Connecticut, United States, 06510

Sponsors and Collaborators

Yale University

Waterbury Hospital

Health Resources and Services Administration (HRSA)

The New York Academy of Medicine

Investigators

Principal Investigator:

Frederick Altice, MD

Yale University

More Information

No publications provided

Responsible Party:	Frederick Altice, MD, Yale University School of Medicine
ClinicalTrials.gov Identifier:	NCT00798538 History of Changes
Other Study ID Numbers:	H97HA03800-03
Study First Received:	November 25, 2008
Last Updated:	June 30, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by Yale University:

Buprenorphine
HIV
Drug Abuse
Drug Addiction
Drug Dependence

Drug Use Disorders
Drug Use Disorder
Substance Abuse
Opiate Addiction
Substance-related disorders

Additional relevant MeSH terms:

Substance-Related Disorders
Behavior, Addictive
Opioid-Related Disorders
Mental Disorders
Compulsive Behavior
Impulsive Behavior
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 February 09, 2012