Back to resultsCognitive-Behavioral Therapy for Pain and Opioid Dependence in Methadone Maintenance Treatment
Primary Purpose
Chronic Pain, Opiate Dependence
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cognitive-Behavioral Therapy for Pain and Opioid Dependence
Methadone Drug Counseling
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain
Eligibility Criteria
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
Sites / Locations
- Methadone Research Unit
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Methadone Drug Counseling
Cognitive-Behavioral Therapy for Pain and Opioid Dependence
Arm Description
Methadone Drug Counseling is provided by skilled drug counselors over a 12 week period and focuses on cessation of illicit drugs
CBT is provided by skilled psychologists in weekly sessions for 12 weeks and focuses on reducing illicit drug use and increasing pain management.
Outcomes
Primary Outcome Measures
Pain reduction
Reduce illicit opioid use
Secondary Outcome Measures
Finalization of treatment manuals
Development and modification of therapy training and process rating measures
Full Information
NCT ID
NCT01334580
First Posted
April 11, 2011
Last Updated
April 1, 2020
Sponsor
Yale University
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT01334580
Brief Title
Cognitive-Behavioral Therapy for Pain and Opioid Dependence in Methadone Maintenance 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 Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Opiate Dependence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Methadone Drug Counseling
Arm Type
Active Comparator
Arm Description
Methadone Drug Counseling is provided by skilled drug counselors over a 12 week period and focuses on cessation of illicit drugs
Arm Title
Cognitive-Behavioral Therapy for Pain and Opioid Dependence
Arm Type
Experimental
Arm Description
CBT is provided by skilled psychologists in weekly sessions for 12 weeks and focuses on reducing illicit drug use and increasing pain management.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive-Behavioral Therapy for Pain and Opioid Dependence
Intervention Description
CBT is provided by skilled psychologists in weekly sessions for 12 weeks and focuses on reducing illicit drug use and increasing pain management.
Intervention Type
Behavioral
Intervention Name(s)
Methadone Drug Counseling
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain reduction
Time Frame
16 weeks
Title
Reduce illicit opioid use
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Finalization of treatment manuals
Time Frame
16 weeks
Title
Development and modification of therapy training and process rating measures
Time Frame
16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Declan Barry, PhD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Methadone Research Unit
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Cognitive-Behavioral Therapy for Pain and Opioid Dependence in Methadone Maintenance Treatment
We'll reach out to this number within 24 hrs