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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
Information provided by (Responsible Party):
Yale University Identifier:
First received: January 2, 2008
Last updated: September 29, 2014
Last verified: September 2014
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
Intervention Model: Factorial Assignment
Masking: None (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 ]
  • Reduced illicit opioid use [ Time Frame: 16 weeks ]

Secondary Outcome Measures:
  • Development of a treatment manual [ Time Frame: 16 weeks ]
  • Development and modification of initial therapy training and process rating measures [ Time Frame: 16 weeks ]

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
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
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
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).

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier: NCT00634803

Contact: Declan T Barry, PhD 203-285-2708
Contact: Richard S Schottenfeld, MD 203-974-7349

United States, Connecticut
Methadone Research Unit Recruiting
New Haven, Connecticut, United States, 06519
Contact: Christopher Cutter, PhD   
Sponsors and Collaborators
Yale University
Principal Investigator: Richard S Schottenfeld, MD Yale University
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Yale University Identifier: NCT00634803     History of Changes
Other Study ID Numbers: HIC0608001776
Study First Received: January 2, 2008
Last Updated: September 29, 2014

Additional relevant MeSH terms:
Chronic Pain
Opioid-Related Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists processed this record on September 21, 2017