Collaborative Care for Opioid Dependence And Pain Pilot Study

Not Applicable

Terminated

• Conditions: Chronic Pain; Opioid Dependence
• Interventions: Behavioral: Telecare Intervention

• Registration Number: NCT04121546
• Lead Sponsor: Indiana University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-10-08
• Study First Submitted QC: 2019-10-08
• Study First Posted: 2019-10-10
• Study Start: 2020-09-18
• Primary Completion: 2022-02-01
• Study Completion: 2022-06-30
• Results First Submitted: 2023-05-08
• Status Verified: 2024-02
• Results First Submitted QC: 2024-02-28
• Last Update Submitted: 2024-02-28
• Results First Posted: 2024-03-01
• Last Update Posted: 2024-03-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

• Chronic pain for at least 6 months
• Receiving daily opioid treatment

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Arm	Telecare Intervention	Patients will receive the telecare intervention.

Primary Outcome Measures

Name	Time	Method
Opioid Dose Change	12 weeks	Percentage change in daily opioid morphine milligram equivalent (MME) dose

Secondary Outcome Measures

Name	Time	Method
Change in PROMIS Pain Interference	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).

Trial Locations

Locations (1)

Indiana University; 🇺🇸 Indianapolis, Indiana, United States