Collaborative Care for Opioid Dependence And Pain Pilot Study

NCT04121546 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2024-03-01

Study results available
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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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • National Center for Advancing Translational Sciences (NCATS)

    collaborator NIH
  • Indiana University

    lead OTHER

Principal Investigators

  • Michael A Bushey, MD, PhD · Indiana University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-18
Primary Completion
2022-02-01
Completion
2022-06-30

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04121546 on ClinicalTrials.gov