Collaborative Care for Opioid Dependence And Pain Pilot Study

Chronic Pain Clinical Trial

— CCODAPP  

Official title:

Collaborative Care for Opioid Dependence And Pain Pilot Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04121546
• Other study ID #: 1905213338
• Secondary ID: KL2TR002530
• Status: Terminated
• Phase: N/A
• Start date: September 18, 2020
• Est. completion date: June 30, 2022

Study information

• Verified date: February 2024
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: June 30, 2022
• Est. primary completion date: February 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Opioid Dependence
• Opioid-Related Disorders

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.

Locations

Country	Name	City	State
United States	Indiana University	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	National Center for Advancing Translational Sciences (NCATS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opioid Dose Change	Percentage change in daily opioid morphine milligram equivalent (MME) dose	12 weeks
Secondary	Change in PROMIS Pain Interference	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