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| Sponsors and Collaborators: |
Yale University National Institute on Drug Abuse (NIDA) |
|---|---|
| Information provided by: | National Institute on Drug Abuse (NIDA) |
| ClinicalTrials.gov Identifier: | NCT00632151 |
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: PM and on-site Cognitive Behavioral Therapy (CBT) |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Counseling for Primary Care Office-Based Buprenorphine |
| Estimated Enrollment: | 140 |
| Study Start Date: | August 2005 |
| Estimated Study Completion Date: | July 2012 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
1) Physician Management
|
Behavioral: 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.
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2: Experimental
2) Physician Management plus Cognitive Behavioral Therapy
|
Behavioral: PM and on-site 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.
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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:
Exclusion Criteria:
Contacts and Locations| Contact: Christopher Cutter, PhD | 203-781-4650 ext 277 | christopher.cutter@yale.edu |
| United States, Connecticut | |
| Yale University School of Medicine | Recruiting |
| New Haven, Connecticut, United States, 06519 | |
| Contact: Christopher Cutter, Ph.D. 203-781-4650 ext 277 christopher.cutter@yale.edu | |
| Principal Investigator: David A. Fiellin, M.D. | |
| The APT Foundation, Inc. -- Welch Building | Recruiting |
| New Haven, Connecticut, United States, 06519 | |
| Contact: Christopher Cutter, Ph.D. 203-781-4650 ext 277 christopher.cutter@yale.edu | |
| Principal Investigator: | David A. Fiellin, MD | Yale University |
More Information
| Responsible Party: | Yale University School of Medicine ( David A. Fiellin, MD ) |
| Study ID Numbers: | 5R01DA19511 |
| Study First Received: | March 6, 2008 |
| Last Updated: | February 22, 2009 |
| ClinicalTrials.gov Identifier: | NCT00632151 History of Changes |
| Health Authority: | United States: Institutional Review Board; United States: Federal Government |
|
buprenorphine buprenorphine/naloxone counseling primary care |
|
Buprenorphine Mental Disorders Narcotic Antagonists Substance-Related Disorders Central Nervous System Depressants Disorders of Environmental Origin |
Narcotics Peripheral Nervous System Agents Analgesics Opioid-Related Disorders Analgesics, Opioid Naloxone |
|
Narcotic Antagonists Physiological Effects of Drugs Central Nervous System Depressants Disorders of Environmental Origin Narcotics Opioid-Related Disorders Pharmacologic Actions Buprenorphine |
Mental Disorders Sensory System Agents Therapeutic Uses Substance-Related Disorders Analgesics Peripheral Nervous System Agents Central Nervous System Agents Analgesics, Opioid |
