Counseling for Primary Care Office-Based Buprenorphine - Full Text View

Sponsors and Collaborators:	Yale University National Institute on Drug Abuse (NIDA)
Information provided by:	Yale University
ClinicalTrials.gov Identifier:	NCT00595764

Purpose

The major goal is to determine whether adding cognitive behavioral therapy to physician management will increase the efficacy of buprenorphine/naloxone treatment in an office-based primary care setting.

Condition	Intervention	Phase
Opiate Dependence	Behavioral: Manual-guided Physician Management (PM) Behavioral: Physician Management (PM) combined with on-site manual-guided Cognitive Behavioral Therapy (CBT)	Phase IV

Drug Information available for: Naloxone Naloxone hydrochloride Buprenorphine Buprenorphine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment
Official Title:	Counseling for Primary Care Office-Based Buprenorphine

Further study details as provided by Yale University:

Primary Outcome Measures:

Illicit opioid use [ Time Frame: 6 months ]

Secondary Outcome Measures:

Retention in treatment [ Time Frame: 6 months ]
Reductions in cocaine use and HIV risk [ Time Frame: 6 months ]
Decreased criminal activity [ Time Frame: 6 months ]
Improved health and employment status [ Time Frame: 6 months ]

Estimated Enrollment:	140
Study Start Date:	August 2005

Arms	Assigned Interventions
1: Active Comparator Physician Management	Behavioral: Manual-guided Physician Management (PM) Manual-guided Physician Management (PM) PM, consistent with federal regulations, is designed to reflect usual care by primary care physicians and includes referral to ancillary services.
2: Experimental Physician Management plus Cognitive Behavioral Therapy	Behavioral: Physician Management (PM) combined with on-site manual-guided Cognitive Behavioral Therapy (CBT) CBT is provided by skilled psychologists in weekly sessions for the first 12 weeks and focuses on reducing illicit drug use and increasing Buprenorphine adherence.

Detailed Description:

To evaluate the need for drug counseling aimed at reducing illicit drug use and increasing buprenorphine/naloxone adherence, the proposed study compares manual-guided Physician Management (PM) and PM combined with on-site manual-guided Cognitive Behavioral Therapy (CBT) in a 24 week randomized clinical trial of buprenorphine/naloxone in a heterogeneous population of opioid dependent patients (N=140) in a primary care clinic. PM, consistent with federal regulations, is designed to reflect usual care by primary care physicians and includes referral to ancillary services. CBT will be provided by skilled psychologists in weekly sessions for the first 12 weeks and focuses on reducing illicit drug use and increasing buprenorphine/naloxone adherence. The study will test the hypothesis that that the addition of CBT to PM will lead to decreased illicit drug use, durable effects after counseling has been discontinued, improved buprenorphine/naloxone adherence and will demonstrate incremental cost-effectiveness in patients receiving buprenorphine/naloxone maintenance in primary care. Primary outcome measures include reductions in illicit opioid use and abstinence achievement, as assessed by weekly urine toxicology testing and self report. Secondary outcome measures include retention in treatment, reductions in cocaine use and HIV risk, decreased criminal activity and improved health and employment status. Utilization and costs of services, spillover effects in the PCC, and patient and staff perceptions of benefits and problems associated with primary care agonist maintenance treatment will also be evaluated. The results of this study will help define the role of professional evidence-based drug counseling in expanding access to treatment with buprenorphine/naloxone.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

opioid dependence

Exclusion Criteria:

current dependence on alcohol, cocaine, benzodiazepines or sedatives
current suicide or homicide risk
current psychotic disorder or untreated major depression
inability to read or understand English
life-threatening or unstable medical problems

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00595764

Contacts

Contact: Declan T. Barry, PhD

203-781-4650 ext 268

declan.barry@yale.edu

Locations

United States, Connecticut
Yale University School of Medicine	Recruiting
New Haven, Connecticut, United States, 06520
The APT Foundation, Inc. -- Welch Building	Recruiting
New Haven, Connecticut, United States, 06519

Sponsors and Collaborators

Yale University

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:

David A. Fiellin, MD

Yale University

More Information

Study ID Numbers:	5 R01 DA19511
Study First Received:	October 3, 2007
Last Updated:	January 15, 2008
ClinicalTrials.gov Identifier:	NCT00595764
Health Authority:	United States: Institutional Review Board

Keywords provided by Yale University:

Buprenorphine
Buprenorphine/naloxone
Counseling
Primary care

Study placed in the following topic categories:

Buprenorphine
Mental Disorders
Substance-Related Disorders

Disorders of Environmental Origin
Opioid-Related Disorders
Naloxone

Additional relevant MeSH terms:

Sensory System Agents
Therapeutic Uses
Narcotic Antagonists
Physiological Effects of Drugs
Central Nervous System Depressants
Narcotics

Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Pharmacologic Actions
Analgesics, Opioid

ClinicalTrials.gov processed this record on January 16, 2009