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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
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
July 31, 2008
Last Updated
April 1, 2020
Sponsor
Yale University
Collaborators
National Institute on Drug Abuse (NIDA)
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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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