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

• Sponsor: Yale University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01334580
• Collaborator: National Institute on Drug Abuse (NIDA) (NIH)
• Enrollment: 40
• Location: 1
• Arms: 2
• Duration (Months): 41
• Patients Per Site Per Month: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Pain; Opiate Dependence	Behavioral: Cognitive-Behavioral Therapy for Pain and Opioid Dependence; Behavioral: Methadone Drug Counseling	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Comparison of Cognitive-Behavioral Therapy and Methadone Drug Counseling for Methadone-Maintained Patients With Co-occurring Chronic Pain and Opioid Dependence
• Study Start Date: Apr 1, 2011
• Actual Primary Completion Date: Sep 1, 2014
• Actual Study Completion Date: Sep 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Methadone Drug Counseling Methadone Drug Counseling is provided by skilled drug counselors over a 12 week period and focuses on cessation of illicit drugs	Behavioral: Methadone Drug Counseling; Methadone Drug Counseling (MDC)is provided by skilled drug counselors over a 12-week period. The primary goal of MDC is cessation of illicit drugs.
Experimental: 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.	Behavioral: 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.

Outcome Measures

Primary Outcome Measures

1. Pain reduction [16 weeks]

2. Reduce illicit opioid use [16 weeks]

Secondary Outcome Measures

1. Finalization of treatment manuals [16 weeks]

2. Development and modification of therapy training and process rating measures [16 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Exclusion Criteria:

• current suicide or homicide risk

• life-threatening or unstable medical problem

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Methadone Research Unit	New Haven	Connecticut	United States	06519

Sponsors and Collaborators

• Yale University
• National Institute on Drug Abuse (NIDA)

Investigators

• Principal Investigator: Declan Barry, PhD, Yale University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yale University
• ClinicalTrials.gov Identifier: NCT01334580
• Other Study ID Numbers: 0703002496_B; K23DA024050-03
• First Posted: Apr 13, 2011
• Last Update Posted: Apr 3, 2020
• Last Verified: Apr 1, 2020

• Additional relevant MeSH terms: Chronic Pain; Opioid-Related Disorders; Methadone

Study Results

No Results Posted as of Apr 3, 2020