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Clinical Trial of Integrated Treatment for Pain and Opioid Dependence (POD)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2014 by Yale University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00634803
First Posted: March 13, 2008
Last Update Posted: September 30, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Yale University
January 2, 2008
March 13, 2008
September 30, 2014
September 2009
May 2015   (Final data collection date for primary outcome measure)
  • Pain reduction [ Time Frame: 16 weeks ]
  • Reduced illicit opioid use [ Time Frame: 16 weeks ]
Same as current
Complete list of historical versions of study NCT00634803 on ClinicalTrials.gov Archive Site
  • Development of a treatment manual [ Time Frame: 16 weeks ]
  • Development and modification of initial therapy training and process rating measures [ Time Frame: 16 weeks ]
Same as current
Not Provided
Not Provided
 
Clinical Trial of Integrated Treatment for Pain and Opioid Dependence
Clinical Trial of Integrated Treatment for Pain and Opioid Dependence
This study is designed to develop an effective psychotherapy for chronic pain and opioid dependence.

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).

Specific Aims:

  1. 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.
  2. 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).
Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Opiate Dependence
  • Chronic Pain
  • Behavioral: CBT
    Cognitive behavioral therapy
  • Drug: Buprenorphine
    buprenorphine/naloxone
  • Other: Educational Counseling
    Didactic, lecture-discussion format to supplement information and advice provided by physicians
  • Other: Physician Management
    Brief physician counseling
  • Experimental: CBT for POD
    Integrated cognitive behavioral therapy for chronic pain and opioid dependence
    Interventions:
    • Behavioral: CBT
    • Drug: 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)
    Interventions:
    • Drug: Buprenorphine
    • Other: Educational Counseling
  • 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.
    Interventions:
    • Drug: Buprenorphine
    • Other: Physician Management
Barry DT, Cutter CJ, Beitel M, Kerns RD, Liong C, Schottenfeld RS. Psychiatric Disorders Among Patients Seeking Treatment for Co-Occurring Chronic Pain and Opioid Use Disorder. J Clin Psychiatry. 2016 Oct;77(10):1413-1419. doi: 10.4088/JCP.15m09963.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
91
August 2015
May 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 18 years of age or older
  • prescription opioid addiction criteria
  • moderate to severe chronic pain
  • seeking or interested in buprenorphine maintenance
  • understand English

Exclusion Criteria:

  • methadone maintenance at a dose greater than 40 mg daily
  • current suicide or homicide risk
  • life-threatening or unstable medical problem
  • pregnancy
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00634803
HIC0608001776
No
Not Provided
Not Provided
Yale University
Yale University
Not Provided
Principal Investigator: Richard S Schottenfeld, MD Yale University
Yale University
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP