Chronic Pain Clinical Trial
— CCODAPPOfficial title:
Collaborative Care for Opioid Dependence And Pain Pilot Study
Verified date | February 2024 |
Source | Indiana University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Indiana University | Indianapolis | Indiana |
Lead Sponsor | Collaborator |
---|---|
Indiana University | National Center for Advancing Translational Sciences (NCATS) |
United States,
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 |
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