Integrating Buprenorphine Into the SFGH AIDS Program - Full Text View

Sponsors and Collaborators:	University of California, San Francisco San Francisco Department of Public Health The New York Academy of Medicine Health Resources & Services Administration
Information provided by:	University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT00263458

Purpose

The purpose of this study is to assess the feasibility, cost, and effectiveness of a model of care designed to integrate buprenorphine treatment for opioid dependence into the HIV primary care clinics at the UCSF Positive Health Program.

Condition	Intervention	Phase
Opioid-Related Disorders HIV Infections	Drug: integration of Buprenorphine treatment into HIV primary-care Behavioral: Integrated HIV care and opioid dependence treatment	Phase IV

MedlinePlus related topics: AIDS

Drug Information available for: Buprenorphine Buprenorphine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Integrating Buprenorphine Into the SFGH AIDS Program (Patient Evaluation Study)

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:

Substance use outcomes at 0, 1, 3, 6, 9 and 12 months. [ Time Frame: 0, 1, 3, 6, 9 and 12 months. ] [ Designated as safety issue: No ]
HIV care outcomes at 0, 1, 3, 6, 9 and 12 months. [ Time Frame: 0, 1, 3, 6, 9 and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

HIV-related health [ Time Frame: baseline, 1, 3, 6, 9 and 12 months ] [ Designated as safety issue: No ]
Quality of life [ Time Frame: 0, 1, 3, 6, 9 and 12 months ] [ Designated as safety issue: No ]
Social functioning [ Time Frame: 0, 1, 3, 6, 9 and 12 months ] [ Designated as safety issue: No ]
Quality of HIV care. [ Time Frame: 0, 3, 6, 9 and 12 months ] [ Designated as safety issue: No ]
Patient satisfaction at 3 months. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	120
Study Start Date:	December 2005
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Integrated: Experimental standard buprenorphine maintenance treatment integrated into HIV-primary-care	Drug: integration of Buprenorphine treatment into HIV primary-care Integration of sublingual Buprenorphine maintenance treatment for opioid-dependence into HIV primary-care. Standard treatment protocols for 12 month projected duration, actual duration and dosage dependent on patient need and clinical determination. Behavioral: Integrated HIV care and opioid dependence treatment Sublingual Buprenorphine maintenance treatment for opioid-dependence delivered in an outpatient setting. Standard treatment protocols for 12 month projected duration, actual duration and dosage dependent on patient need and clinical determination.
Non-integrated: Active Comparator standard buprenorphine maintenance treatment in an outpatient setting	Behavioral: Integrated HIV care and opioid dependence treatment Sublingual Buprenorphine maintenance treatment for opioid-dependence delivered in an outpatient setting. Standard treatment protocols for 12 month projected duration, actual duration and dosage dependent on patient need and clinical determination.

Arms

Assigned Interventions

Integrated: Experimental

standard buprenorphine maintenance treatment integrated into HIV-primary-care

Drug: integration of Buprenorphine treatment into HIV primary-care

Integration of sublingual Buprenorphine maintenance treatment for opioid-dependence into HIV primary-care. Standard treatment protocols for 12 month projected duration, actual duration and dosage dependent on patient need and clinical determination.

Behavioral: Integrated HIV care and opioid dependence treatment

Sublingual Buprenorphine maintenance treatment for opioid-dependence delivered in an outpatient setting. Standard treatment protocols for 12 month projected duration, actual duration and dosage dependent on patient need and clinical determination.

Non-integrated: Active Comparator

standard buprenorphine maintenance treatment in an outpatient setting

Behavioral: Integrated HIV care and opioid dependence treatment

Sublingual Buprenorphine maintenance treatment for opioid-dependence delivered in an outpatient setting. Standard treatment protocols for 12 month projected duration, actual duration and dosage dependent on patient need and clinical determination.

Detailed Description:

The UCSF Positive Health Program (formerly called the AIDS Program) at San Francisco General Hospital (SFGH) is one of the oldest and largest HIV/AIDS clinics in the United States. Located at the public hospital serving medically indigent residents of San Francisco, the Positive Health Program (PHP) provides over 2,000 patient visits per month to 2,300 patients in a comprehensive HIV primary care setting. The clinic population is disproportionately affected by heroin and other opiate abuse problems. Opiate replacement therapy (ORT) has a stabilizing effect in HIV-infected injecting drug users (IDU) and is associated with greater acceptance of antiretroviral (ARV) therapy, higher ARV adherence, and greater engagement in appropriate HIV-related health care. However, there are insufficient resources to meet the critical substance abuse treatment needs among our opioid-dependent patients.

In partnership with the Community Behavioral Health Services (CBHS) section of the San Francisco Department of Public Health (SFDPH), the UCSF Positive Health Program (PHP) at San Francisco General Hospital (SFGH) has developed a model of care, which provides opioid-dependent patients with integrated, office-based buprenorphine ORT in the HIV primary care setting. The program also offers primary care providers with education and training on addiction, opiate addiction treatment, and the appropriate use of buprenorphine. An evaluation of the program is planned to examine: (1) its effects on the health and substance use of patients; (2) program costs; and (3) what broader impact the program has on providers, institutions, and local systems. In the patient evaluation study, eligible, opioid-dependent patients that receive primary HIV care at the PHP will be randomly assigned to receive buprenorphine ORT for twelve months either in the integrated HIV primary care setting (intervention group) versus a non-integrated substance abuse treatment clinic setting (comparison group). Data will be abstracted from medical chart reviews and will be collected from patients using standardized instruments and satisfaction surveys.

Eligibility

Ages Eligible for Study:	19 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age > 18 years
Fluent in English
Receive HIV primary care at the UCSF Positive Health Program
Meet DSM-IVR criteria for opioid dependence
Meet clinical criteria for buprenorphine treatment (see Exclusion Criteria)
Plan to stay in the San Francisco Bay Area for the next 12 months

Exclusion Criteria:

Severe hepatic dysfunction, i.e., AST and/or ALT > 5X upper limit of normal
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 or opiate analgesic doses exceed level allowing for safe transition to buprenorphine
Pregnant women and women actively trying to become pregnant

Potential subjects also will be excluded for:

Any medical condition(s), which, in the opinion of the investigator, would interfere with the patient's ability to participate in or adhere to the requirements of this study
Unable or who decline to provide informed consent for the evaluation

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00263458

Contacts

Contact: Bob Thawley

(415) 514-9370 ext 518

RThawley@php.ucsf.edu

Locations

United States, California
UCSF Positive Health Program	Recruiting
San Francisco, California, United States, 94110
Principal Investigator: Paula J Lum, MD MPH
Principal Investigator: Jacqueline P Tulsky, MD
Sub-Investigator: Alice A Gleghorn, PhD
Sub-Investigator: David Hersh, MD

Sponsors and Collaborators

University of California, San Francisco

San Francisco Department of Public Health

The New York Academy of Medicine

Health Resources & Services Administration

Investigators

Principal Investigator:

Paula J Lum, MD, MPH

University of California, San Francisco

More Information

The UCSF Positive Health Program at the University of California San Francisco This link exits the ClinicalTrials.gov site

Integrated Buprenorphine & HIV Care Evaluation and Support Center This link exits the ClinicalTrials.gov site

CSAT Buprenorphine This link exits the ClinicalTrials.gov site

Community Behavioral Health Services, San Francisco Department of Public Health This link exits the ClinicalTrials.gov site

Responsible Party:	University of California, San Francisco ( Dr. Paula J. Lum, MD MPH )
Study ID Numbers:	H97HA03799
Study First Received:	December 6, 2005
Last Updated:	May 20, 2008
ClinicalTrials.gov Identifier:	NCT00263458
Health Authority:	United States: Institutional Review Board

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 January 16, 2009