Counseling for Primary Care Office-based Buprenorphine
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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 |
- Illicit opioid use [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Retention in treatment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Reductions in cocaine use and HIV risk [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Decreased criminal activity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Improved health and employment status [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| 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 |
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| United States, Connecticut | |
| Yale University School of Medicine | |
| New Haven, Connecticut, United States, 06520 | |
| The APT Foundation, Inc. -- Welch Building | |
| New Haven, Connecticut, United States, 06519 | |
| Principal Investigator: | David A. Fiellin, MD | Yale University |
More Information
No publications provided by Yale University
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 |
| Last Updated: | February 7, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Yale University:
|
Buprenorphine Buprenorphine/naloxone Counseling Primary care |
Additional relevant MeSH terms:
|
Opioid-Related Disorders Substance-Related Disorders Mental Disorders 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 May 22, 2013