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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
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid Dependence

Eligibility Criteria

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

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

First Posted
October 8, 2019
Last Updated
September 19, 2022
Sponsor
Indiana University
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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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