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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Yale University
Sponsor:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT00634803
First received: January 2, 2008
Last updated: September 29, 2014
Last verified: September 2014
  Purpose

This study is designed to develop an effective psychotherapy for chronic pain and opioid dependence.


Condition Intervention Phase
Opiate Dependence
Chronic Pain
Behavioral: CBT
Drug: Buprenorphine
Other: Educational Counseling
Other: Physician Management
Phase 1
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Pain reduction [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Reduced illicit opioid use [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 91
Study Start Date: September 2009
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CBT for POD
Integrated cognitive behavioral therapy for chronic pain and opioid dependence
Behavioral: CBT
Cognitive behavioral therapy
Drug: Buprenorphine
buprenorphine/naloxone
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)
Drug: Buprenorphine
buprenorphine/naloxone
Other: 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.
Drug: Buprenorphine
buprenorphine/naloxone
Other: Physician Management
Brief physician counseling

Detailed Description:

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).
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00634803

Contacts
Contact: Declan T Barry, PhD 203-285-2708 declan.barry@yale.edu
Contact: Richard S Schottenfeld, MD 203-974-7349 richard.schottenfeld@yale.edu

Locations
United States, Connecticut
Methadone Research Unit Recruiting
New Haven, Connecticut, United States, 06519
Contact: Christopher Cutter, PhD       christopher.cutter@yale.edu   
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Richard S Schottenfeld, MD Yale University
  More Information

No publications provided

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00634803     History of Changes
Other Study ID Numbers: HIC0608001776
Study First Received: January 2, 2008
Last Updated: September 29, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Chronic Pain
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms
Buprenorphine
Analgesics
Analgesics, Opioid
Central Nervous System Agents
Central Nervous System Depressants
Narcotic Antagonists
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014