Cognitive-Behavioral Therapy for Pain and Opioid Dependence in Methadone Maintenance Treatment
Comparison of Cognitive-Behavioral Therapy and Methadone Drug Counseling for Methadone-Maintained Patients With Co-occurring Chronic Pain and Opioid Dependence
2 other identifiers
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 chronic-pain
Started Apr 2011
Longer than P75 for phase_1 chronic-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
April 11, 2011
CompletedFirst Posted
Study publicly available on registry
April 13, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedApril 3, 2020
April 1, 2020
3.4 years
April 11, 2011
April 1, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Pain reduction
16 weeks
Reduce illicit opioid use
16 weeks
Secondary Outcomes (2)
Finalization of treatment manuals
16 weeks
Development and modification of therapy training and process rating measures
16 weeks
Study Arms (2)
Methadone Drug Counseling
ACTIVE COMPARATORMethadone Drug Counseling is provided by skilled drug counselors over a 12 week period and focuses on cessation of illicit drugs
Cognitive-Behavioral Therapy for Pain and Opioid Dependence
EXPERIMENTALCBT is provided by skilled psychologists in weekly sessions for 12 weeks and focuses on reducing illicit drug use and increasing pain management.
Interventions
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 (MDC)is provided by skilled drug counselors over a 12-week period. The primary goal of MDC is cessation of illicit drugs.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- current suicide or homicide risk
- life-threatening or unstable medical problem
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yale Universitylead
- National Institute on Drug Abuse (NIDA)collaborator
Study Sites (1)
Methadone Research Unit
New Haven, Connecticut, 06519, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Declan Barry, PhD
Yale University
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 11, 2011
First Posted
April 13, 2011
Study Start
April 1, 2011
Primary Completion
September 1, 2014
Study Completion
September 1, 2014
Last Updated
April 3, 2020
Record last verified: 2020-04