Collaborative Care for Opioid Dependence And Pain Pilot Study

NCT04121546 | Terminated Results

• 2 other identifiers: 1905213338KL2TR002530
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid Dependence; Chronic Pain

Outcome Measures

Primary Outcomes (1)

• Opioid Dose Change

  Percentage change in daily opioid morphine milligram equivalent (MME) dose

  12 weeks

Secondary Outcomes (1)

• Change in PROMIS Pain Interference

  12 weeks

Study Arms (2)

Intervention Arm

EXPERIMENTAL

Patients will receive the telecare intervention.

Behavioral: Telecare Intervention

Usual Care Arm

NO INTERVENTION

Patients will receive usual care.

Interventions

Telecare Intervention BEHAVIORAL

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.

Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Not speaking English
• Significant psychiatric impairment including severe cognitive impairment, suicidality, schizophrenia, or bipolar disorder
• Known life expectancy of less than 6 months

Sponsors & Collaborators

• Indiana University: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

Indiana University

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders; Chronic Pain

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Due to the low rate of enrollment/completion, the design was determined to be infeasible and the trial was ended early.

Results Point of Contact

• Title: Dr. Michael Bushey
• Organization: Indiana University School of Medicine

mabushey@iu.edu

3179637300

Study Officials

• Michael A Bushey, MD, PhD

  Indiana University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychiatry

Study Record Dates

• First Submitted: October 8, 2019
• First Posted: October 10, 2019
• Study Start: September 18, 2020
• Primary Completion: February 1, 2022
• Study Completion: June 30, 2022
• Last Updated: March 1, 2024
• Results First Posted: March 1, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)