Clinical Trial of Integrated Treatment for Pain and Opioid Dependence (POD)
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|ClinicalTrials.gov Identifier: NCT00634803|
Recruitment Status : Unknown
Verified September 2014 by Yale University.
Recruitment status was: Recruiting
First Posted : March 13, 2008
Last Update Posted : September 30, 2014
|Condition or disease||Intervention/treatment||Phase|
|Opiate Dependence Chronic Pain||Behavioral: CBT Drug: Buprenorphine Other: Educational Counseling Other: Physician Management||Phase 1 Phase 2|
This study aims to develop a novel manualized intervention using tailored cognitive-behavioral treatment (CBT) and buprenorphine medication to effectively treat the co-occurring disorders of non-malignant pain and opioid dependence (POD).
- To conduct a pre-pilot phase with 16 patients with POD receiving buprenorphine maintenance treatment (BMT). In the pre-pilot phase, we will also explore the effects of different daily buprenorphine dosages on pain and opiate use.
- To conduct a pilot randomized, clinical trial to obtain data regarding the feasibility, acceptability and efficacy (compared to Physician Management(PM) only) of manual-guided CBT or Educational Counseling (EC) for patients with POD treated with BMT (N=75).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||91 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Trial of Integrated Treatment for Pain and Opioid Dependence|
|Study Start Date :||September 2009|
|Estimated Primary Completion Date :||May 2015|
|Estimated Study Completion Date :||August 2015|
Experimental: CBT for POD
Integrated cognitive behavioral therapy for chronic pain and opioid dependence
Cognitive behavioral therapyDrug: Buprenorphine
Active Comparator: Educational Counseling for POD
Educational Counseling is a didactic, lecture-discussion format to supplement the information and advice provided by physicians in physician management (PM)
buprenorphine/naloxoneOther: Educational Counseling
Didactic, lecture-discussion format to supplement information and advice provided by physicians
Active Comparator: Physician Management
PM is a relatively brief intervention that approximates the medically focused advice and brief counseling about medical issues that is typically provided by physicians to patients with chronic pain or other chronic medical conditions, such as diabetes or asthma.
buprenorphine/naloxoneOther: Physician Management
Brief physician counseling
- Pain reduction [ Time Frame: 16 weeks ]
- Reduced illicit opioid use [ Time Frame: 16 weeks ]
- Development of a treatment manual [ Time Frame: 16 weeks ]
- Development and modification of initial therapy training and process rating measures [ Time Frame: 16 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00634803
|Contact: Declan T Barry, PhDfirstname.lastname@example.org|
|Contact: Richard S Schottenfeld, MDemail@example.com|
|United States, Connecticut|
|Methadone Research Unit||Recruiting|
|New Haven, Connecticut, United States, 06519|
|Contact: Christopher Cutter, PhD firstname.lastname@example.org|
|Principal Investigator:||Richard S Schottenfeld, MD||Yale University|