Clinical Trial of Integrated Treatment for Pain and Opioid Dependence (POD)
This study is designed to develop an effective psychotherapy for chronic pain and opioid dependence.
Other: Educational Counseling
Other: Physician Management
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Clinical Trial of Integrated Treatment for Pain and Opioid Dependence|
- Pain reduction [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
- Reduced illicit opioid use [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
- Development of a treatment manual [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
- Development and modification of initial therapy training and process rating measures [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||September 2009|
|Estimated Study Completion Date:||August 2014|
|Estimated Primary Completion Date:||August 2014 (Final data collection date for primary outcome measure)|
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
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).
|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|