Collaborative Care for Opioid Dependence And Pain Pilot Study (CCODAPP)
Primary Purpose
Opioid Dependence, Chronic Pain
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Telecare Intervention
Sponsored by
About this trial
This is an interventional treatment trial for Opioid Dependence
Eligibility Criteria
Inclusion Criteria:
- Chronic pain for at least 6 months
- Receiving daily opioid treatment
Exclusion Criteria:
- Not speaking English
- Significant psychiatric impairment including severe cognitive impairment, suicidality, schizophrenia, or bipolar disorder
- Known life expectancy of less than 6 months
Sites / Locations
- Indiana University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention Arm
Usual Care Arm
Arm Description
Patients will receive the telecare intervention.
Patients will receive usual care.
Outcomes
Primary Outcome Measures
Opioid Reduction
Percentage reduction in daily opioid dose taken
Secondary Outcome Measures
Pain Interference
Change in PROMIS 4-item pain interference scale
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04121546
Brief Title
Collaborative Care for Opioid Dependence And Pain Pilot Study
Acronym
CCODAPP
Official Title
Collaborative Care for Opioid Dependence And Pain Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Terminated
Why Stopped
Insufficient enrollment
Study Start Date
September 18, 2020 (Actual)
Primary Completion Date
February 1, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This pilot study evaluates a collaborative care program to assist with opioid tapering in patients with chronic pain. Patients will be randomized to receive the intervention or usual care.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Dependence, Chronic Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention Arm
Arm Type
Experimental
Arm Description
Patients will receive the telecare intervention.
Arm Title
Usual Care Arm
Arm Type
No Intervention
Arm Description
Patients will receive usual care.
Intervention Type
Behavioral
Intervention Name(s)
Telecare Intervention
Intervention Description
Patients will meet with a care coordinator to discuss current opioid use pattern and potential reduction strategies. Participants will fill out baseline measures. A 6 week positive psychology intervention will also be introduced in which patients will practice different techniques each week over 6 weeks, and will then practice incorporating a single technique into daily practice for the remaining 6 weeks. During the first 6 weeks, patients will have weekly check in meetings with a care manager to report on any withdrawal symptoms. These meetings will space to ever other week during the remaining 6 weeks. Possible treatment adjustments will be discussed between the care coordinator and primary investigator at weekly meetings. At the completion of the 12 week study, patients will complete outcome measures.
Primary Outcome Measure Information:
Title
Opioid Reduction
Description
Percentage reduction in daily opioid dose taken
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Pain Interference
Description
Change in PROMIS 4-item pain interference scale
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Chronic pain for at least 6 months
Receiving daily opioid treatment
Exclusion Criteria:
Not speaking English
Significant psychiatric impairment including severe cognitive impairment, suicidality, schizophrenia, or bipolar disorder
Known life expectancy of less than 6 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael A Bushey, MD, PhD
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Collaborative Care for Opioid Dependence And Pain Pilot Study
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