Skip to main content
Clinical Trials/NCT04190563
NCT04190563
Completed
N/A

Affective and Inflammatory Reactivity to Pain in Opioid Use Disorder

Mclean Hospital1 site in 1 country89 target enrollmentMay 4, 2021

Overview

Phase
N/A
Intervention
Pain De-Catastrophizing
Conditions
Opioid-use Disorder
Sponsor
Mclean Hospital
Enrollment
89
Locations
1
Primary Endpoint
Craving
Status
Completed
Last Updated
19 days ago

Overview

Brief Summary

The goal of this study is to investigate the association between response to pain and opioid craving in people with opioid use disorder. In this study, adults with opioid use disorder will be randomized to one of two brief education sessions followed by an assessment of response to pain. Investigators will test the association between response to pain and opioid craving.

Registry
clinicaltrials.gov
Start Date
May 4, 2021
End Date
July 31, 2025
Last Updated
19 days ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

McHugh, R. Kathryn

Assistant Professor

Mclean Hospital

Eligibility Criteria

Inclusion Criteria

  • age 18 years or older;
  • diagnosis of opioid use disorder
  • chronic pain
  • ability to read and provide informed consent

Exclusion Criteria

  • major psychiatric or medical condition that would interfere with participation
  • current opioid withdrawal
  • currently receiving opioid analgesic medication for pain
  • recent history of myocardial infarction or other serious cardiovascular condition
  • current peripheral neuropathy, active vasculitis or severe peripheral vascular disease
  • systematic inflammatory or autoimmune disorder
  • admitted to current treatment episode on an involuntary status

Arms & Interventions

Pain De-Catastrophizing

Brief behavioral education on how to modify the interpretation of pain.

Intervention: Pain De-Catastrophizing

Pain Education

Brief behavioral education on pain.

Intervention: Pain Education

Outcomes

Primary Outcomes

Craving

Time Frame: 30 minutes

Investigators will assess opioid craving using the Opioid Craving Scale, a participant-reported measure of opioid craving. Investigators will measure changes in Opioid Craving Scale total scores from baseline (prior to the one-time intervention) to immediately after the intervention. This is a continuous measure that will be measured twice within this single-session experimental session. The total scale score is calculated as an average of the 3 items, with a range from 0-10, with higher scores reflecting more craving.

Study Sites (1)

Loading locations...

Similar Trials