Collaborative Care for Opioid Dependence And Pain Pilot Study (CCODAPP)

February 28, 2024 updated by: Michael A. Bushey, Indiana University
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Arm
Patients will receive the telecare intervention.
Behavioral: Telecare Intervention
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.
No Intervention: Usual Care Arm
Patients will receive usual care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opioid Dose Change
Time Frame: 12 weeks
Percentage change in daily opioid morphine milligram equivalent (MME) dose
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in PROMIS Pain Interference
Time Frame: 12 weeks
The Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.1 - Pain Interference 8a is an 8-item scale from the PROMIS item bank which assesses self-reported consequences of pain on relevant aspects of one's life. This includes the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. Each item has a 5-point Likert response, with total scores ranging from 8 - 40, with higher numbers corresponding to worse pain interference outcomes. For this outcome, the score at baseline was subtracted from the score at 12 weeks to determine the change score, with negative change scores demonstrating symptom improvement (i.e. less pain interference).
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Collaborators

National Center for Advancing Translational Sciences (NCATS)

Investigators

  • Principal Investigator: Michael A Bushey, MD, PhD, Indiana University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 18, 2020

Primary Completion (Actual)

February 1, 2022

Study Completion (Actual)

June 30, 2022

Study Registration Dates

First Submitted

October 8, 2019

First Submitted That Met QC Criteria

October 8, 2019

First Posted (Actual)

October 10, 2019

Study Record Updates

Last Update Posted (Actual)

March 1, 2024

Last Update Submitted That Met QC Criteria

February 28, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1905213338
  • KL2TR002530 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Pain

Clinical Trials on Telecare Intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Georgia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe