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Clinical Trials/NCT04121546
NCT04121546TerminatedNot Applicable

Collaborative Care for Opioid Dependence And Pain Pilot Study

Indiana University1 site in 1 country6 target enrollmentStarted: September 18, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
6
Locations
1
Primary Endpoint
Opioid Dose Change

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Intervention Arm

Experimental

Patients will receive the telecare intervention.

Intervention: Telecare Intervention (Behavioral)

Usual Care Arm

No Intervention

Patients will receive usual care.

Outcomes

Primary Outcomes

Opioid Dose Change

Time Frame: 12 weeks

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

Secondary Outcomes

  • Change in PROMIS Pain Interference(12 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Michael A. Bushey

Assistant Professor of Psychiatry

Indiana University

Study Sites (1)

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