Pain, Inflammation and Opioid Craving

Opioid-use Disorder Clinical Trial

Official title:

Affective and Inflammatory Reactivity to Pain in Opioid Use Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04190563
• Other study ID #: 2019P002720
• Secondary ID: R01DA045632
• Status: Recruiting
• Phase: N/A
• Start date: May 4, 2021
• Est. completion date: July 15, 2025

Study information

• Verified date: January 2024
• Source: Mclean Hospital
• Contact: Rebecca K McHugh, PhD
• Phone: 617-855-2000
• Email: kmchugh[@]mclean.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 15, 2025
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Opioid-Related Disorders
• Opioid-use Disorder

Intervention

Behavioral:
• Pain De-Catastrophizing
Experimenter-administered education and skill practice.
• Pain Education
Experimenter-administered education.

Locations

Country	Name	City	State
United States	McLean Hospital	Belmont	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Mclean Hospital	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Craving	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.	30 minutes