Cognitive-Behavioral Therapy for Pain and Opioid Dependence in Methadone Maintenance Treatment

Phase 1

Completed

• Conditions: Opiate Dependence; Chronic Pain
• Interventions: Behavioral: Cognitive-Behavioral Therapy for Pain and Opioid Dependence; Behavioral: Methadone Drug Counseling

• Registration Number: NCT01334580
• Lead Sponsor: Yale University

Brief Summary

This study involves the comparison of two treatment approaches for patients with chronic pain who are entering methadone maintenance treatment (MMT) for opioid addiction: (a) an integrated counseling that addresses both chronic pain and opioid dependence(POD)and (b) a counseling intervention that addresses opioid dependence only.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-04-11
• Study First Submitted QC: 2011-04-11
• Study First Posted: 2011-04-13
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-01
• Last Update Posted: 2020-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 18 years of age or older
• prescription opioid or heroin addiction
• moderate to severe chronic pain
• enrolled in methadone maintenance at the APT Foundation for opioid addiction
• understand English

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Exclusion Criteria

• current suicide or homicide risk
• life-threatening or unstable medical problem

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Cognitive-Behavioral Therapy for Pain and Opioid Dependence	Cognitive-Behavioral Therapy for Pain and Opioid Dependence	CBT is provided by skilled psychologists in weekly sessions for 12 weeks and focuses on reducing illicit drug use and increasing pain management.
Methadone Drug Counseling	Methadone Drug Counseling	Methadone Drug Counseling is provided by skilled drug counselors over a 12 week period and focuses on cessation of illicit drugs

Primary Outcome Measures

Name	Time	Method
Pain reduction	16 weeks
Reduce illicit opioid use	16 weeks

Secondary Outcome Measures

Name	Time	Method
Finalization of treatment manuals	16 weeks
Development and modification of therapy training and process rating measures	16 weeks

Trial Locations

Locations (1)

Methadone Research Unit; 🇺🇸 New Haven, Connecticut, United States