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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04121546
Other study ID # 1905213338
Secondary ID KL2TR002530
Status Terminated
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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