Counseling for Primary Care Office-based Buprenorphine
April 1, 2020 updated by: Yale University
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Interventional
Enrollment (Actual)
141
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Connecticut
-
New Haven, Connecticut, United States, 06519
- The APT Foundation, Inc. -- Welch Building
-
New Haven, Connecticut, United States, 06519
- Yale New Haven Hospital Primary Care Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 1
Physician Management
|
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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Illicit Opioid Abstinence
Time Frame: 6 months
|
number of weeks of abstinence from illicit opioids, as documented by urine toxicology and self-report.
Range 0 - 24.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Treatment Completion
Time Frame: 6 months
|
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.
|
6 months
|
|
Cocaine Abstinence
Time Frame: 6 months
|
Total weeks of cocaine abstinence as documented by weekly urine toxicology analysis.
Range from 0 to 24.
|
6 months
|
|
Criminal Activity- Addiction Severity Index (ASI) Legal Composite Score.
Time Frame: 6 months
|
The ASI Legal Composite score ranges from 0 to 1 with higher scores corresponding to greater legal problems.
|
6 months
|
|
Overall Health- Short Form (36) Health Survey
Time Frame: 6 months
|
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. |
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: David A. Fiellin, MD, Yale University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2005
Primary Completion (Actual)
February 1, 2011
Study Completion (Actual)
February 1, 2011
Study Registration Dates
First Submitted
October 3, 2007
First Submitted That Met QC Criteria
January 15, 2008
First Posted (Estimate)
January 16, 2008
Study Record Updates
Last Update Posted (Actual)
April 3, 2020
Last Update Submitted That Met QC Criteria
April 1, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0504027657
- 5R01DA019511 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.