Chronic Pain and Opioid Dependence Assessment and Treatment

Not Applicable

Completed

• Conditions: Chronic Pain; Opioid Dependency
• Interventions: Behavioral: Integrated Cognitive Behavioral Therapy

• Registration Number: NCT00727675
• Lead Sponsor: Yale University

Brief Summary

This study involves the development of an integrated psychotherapy that addresses both chronic pain and opioid dependence(POD).

Detailed Description

To conduct a pre-pilot study with 20 POD patients to a) evaluate the acceptability and potential efficacy of specific sessions (i.e., reduced illicit opioid use as assessed by urine toxicology and self-report findings, and decreased pain as evidenced by attenuated pain intensity and pain interference on self-report measures from baseline throughout treatment) for inclusion in integrated Cognitive Behavioral Therapy (CBT) for POD and the sequence of sessions, b) assess patients' satisfaction with integrated CBT as evidenced by qualitative feedback from individual exit interviews, and c) develop and modify initial therapist training and process rating measures. Products will include a) a manual for integrated CBT for POD to be used in opioid treatment programs and primary care settings with POD patients, b) therapist training materials, and c) process rating instruments.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2008-07-31
• Study Start: 2008-08
• Study First Submitted QC: 2008-08-01
• Study First Posted: 2008-08-04
• Primary Completion: 2014-07
• Study Completion: 2015-07
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-01
• Last Update Posted: 2020-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• at least 18 years of age
• currently in Methadone Maintenance Treatment (MMT) at the APT Foundation in New Haven, CT
• opioid dependence
• experience moderate to severe chronic pain

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Exclusion Criteria

• current suicide or homicide risk
• are unable to complete the informed consent or surveys because of psychiatric impairment
• have cognitive impairment
• are unable to read or understand English

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Integrated Cognitive Behavioral Therapy	Integrated Cognitive Behavioral Therapy for pain reduction and opioid dependence.

Primary Outcome Measures

Name	Time	Method
Reduced illicit opioid use and pain	12 weeks

Trial Locations

Locations (1)

Yale University School of Medicine; 🇺🇸 New Haven, Connecticut, United States