Trial record 18 of 80 for:
Open Studies | "Opioid-Related Disorders"
Clinical Trial of Integrated Treatment for Pain and Opioid Dependence (POD)
This study is currently recruiting participants.
Verified May 2013 by Yale University
Sponsor:
Yale University
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT00634803
First received: January 2, 2008
Last updated: May 13, 2013
Last verified: May 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 2014 |
| Estimated Primary Completion Date: | August 2014 (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:
- 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.
- 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
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: | May 13, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Opioid-Related Disorders Substance-Related Disorders Mental Disorders Buprenorphine Analgesics, Opioid Analgesics Sensory System Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Central Nervous System Depressants Narcotic Antagonists Narcotics |
ClinicalTrials.gov processed this record on May 19, 2013