Pain, Inflammation and Opioid Craving

Not Applicable

Recruiting

• Conditions: Opioid-use Disorder
• Interventions: Behavioral: Pain Education; Behavioral: Pain De-Catastrophizing

• Registration Number: NCT04190563
• Lead Sponsor: Mclean Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-05
• Study First Submitted QC: 2019-12-05
• Study First Posted: 2019-12-09
• Study Start: 2021-05-04
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-09
• Last Update Posted: 2025-05-13
• Primary Completion: 2025-07-31
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pain Education	Pain Education	Brief behavioral education on pain.
Pain De-Catastrophizing	Pain De-Catastrophizing	Brief behavioral education on how to modify the interpretation of pain.

Primary Outcome Measures

Name	Time	Method
Craving	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.

Trial Locations

Locations (1)

McLean Hospital; 🇺🇸 Belmont, Massachusetts, United States