Chronic Pain and Opioid Dependence Assessment and Treatment (CPODAT)
Primary Purpose
Chronic Pain, Opioid Dependency
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Integrated Cognitive Behavioral Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain focused on measuring chronic pain, opioid dependence, Cognitive Behavioral Therapy (CBT)
Eligibility Criteria
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
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
Sites / Locations
- Yale University School of Medicine
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
1
Arm Description
Integrated Cognitive Behavioral Therapy for pain reduction and opioid dependence.
Outcomes
Primary Outcome Measures
Reduced illicit opioid use and pain
Secondary Outcome Measures
Full Information
NCT ID
NCT00727675
First Posted
July 31, 2008
Last Updated
April 1, 2020
Sponsor
Yale University
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT00727675
Brief Title
Chronic Pain and Opioid Dependence Assessment and Treatment
Acronym
CPODAT
Official Title
Chronic Pain and Opioid Dependence Assessment and Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2015 (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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Opioid Dependency
Keywords
chronic pain, opioid dependence, Cognitive Behavioral Therapy (CBT)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Other
Arm Description
Integrated Cognitive Behavioral Therapy for pain reduction and opioid dependence.
Intervention Type
Behavioral
Intervention Name(s)
Integrated Cognitive Behavioral Therapy
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.
Primary Outcome Measure Information:
Title
Reduced illicit opioid use and pain
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Declan T. Barry, Ph.D.
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
27574837
Citation
Barry DT, Cutter CJ, Beitel M, Kerns RD, Liong C, Schottenfeld RS. Psychiatric Disorders Among Patients Seeking Treatment for Co-Occurring Chronic Pain and Opioid Use Disorder. J Clin Psychiatry. 2016 Oct;77(10):1413-1419. doi: 10.4088/JCP.15m09963.
Results Reference
derived
Learn more about this trial
Chronic Pain and Opioid Dependence Assessment and Treatment
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