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

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. Identifier: NCT00634803
Recruitment Status : Unknown
Verified September 2014 by Yale University.
Recruitment status was:  Recruiting
First Posted : March 13, 2008
Last Update Posted : September 30, 2014
Information provided by (Responsible Party):
Yale University

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

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

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).

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 91 participants
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
Study Start Date : September 2009
Estimated Primary Completion Date : May 2015
Estimated Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Pain reduction [ Time Frame: 16 weeks ]
  2. Reduced illicit opioid use [ Time Frame: 16 weeks ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Yale University Identifier: NCT00634803     History of Changes
Other Study ID Numbers: HIC0608001776
First Posted: March 13, 2008    Key Record Dates
Last Update Posted: September 30, 2014
Last Verified: September 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