Counseling for Primary Care Office-based Buprenorphine

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
David Fiellin, Yale University
ClinicalTrials.gov Identifier:
NCT00595764
First received: October 3, 2007
Last updated: September 30, 2014
Last verified: September 2014
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Counseling for Primary Care Office-based Buprenorphine

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Illicit Opioid Abstinence [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    number of weeks of abstinence from illicit opioids, as documented by urine toxicology and self-report. Range 0 - 24.


Secondary Outcome Measures:
  • Treatment Completion [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The number of patients who completed the study (did not meet the criteria for protective transfer baseed on drug use, did not miss medication for more than seven days, or did not miss three or more Physician Management sessions) at 24 weeks.

  • Cocaine Abstinence [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Total weeks of cocaine abstinence as documented by weekly urine toxicology analysis. Range from 0 to 24.

  • Criminal Activity- Addiction Severity Index (ASI) Legal Composite Score. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The ASI Legal Composite score ranges from 0 to 1 with higher scores corresponding to greater legal problems.

  • Overall Health- Short Form (36) Health Survey [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    Short Form (36) Health Survey overall score ranges from 0 to 100. Computed as the mean of all SF-36 subscales.

    The SF-36 is a multi-purpose, short-form health survey with only 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index. Lower scores are greater disability and higher scores are greater health functioning.



Enrollment: 141
Study Start Date: August 2005
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
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.
Experimental: 2
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Connecticut
The APT Foundation, Inc. -- Welch Building
New Haven, Connecticut, United States, 06519
Yale New Haven Hospital Primary Care Center
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: David A. Fiellin, MD Yale University
  More Information

Publications:
Responsible Party: David Fiellin, Professor of Medicine, Yale University
ClinicalTrials.gov Identifier: NCT00595764     History of Changes
Obsolete Identifiers: NCT00632151
Other Study ID Numbers: 5 R01 DA19511, 5R01DA019511
Study First Received: October 3, 2007
Results First Received: July 18, 2013
Last Updated: September 30, 2014
Health Authority: United States: Federal Government

Keywords provided by Yale University:
Buprenorphine
Buprenorphine/naloxone
Counseling
Primary care

Additional relevant MeSH terms:
Buprenorphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Narcotic Antagonists

ClinicalTrials.gov processed this record on October 19, 2014