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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Yale University
Sponsor:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT00634803
First received: January 2, 2008
Last updated: December 9, 2013
Last verified: December 2013

January 2, 2008
December 9, 2013
September 2009
August 2014   (final data collection date for primary outcome measure)
  • Pain reduction [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Reduced illicit opioid use [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
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 ] [ 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 ]
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
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
91
August 2014
August 2014   (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
Both
18 Years to 65 Years
No
Contact: Declan T Barry, PhD 203-285-2708 declan.barry@yale.edu
Contact: Richard S Schottenfeld, MD 203-974-7349 richard.schottenfeld@yale.edu
United States
 
NCT00634803
HIC0608001776
No
Yale University
Yale University
Not Provided
Principal Investigator: Richard S Schottenfeld, MD Yale University
Yale University
December 2013

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