Pain, Inflammation and Opioid Craving

NCT04190563 | Completed Results

• 2 other identifiers: 2019P002720R01DA045632
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid-use Disorder

Outcome Measures

Primary Outcomes (1)

• Craving

  Investigators will assess opioid craving using the Opioid Craving Scale, a participant-reported measure of opioid craving. This is a continuous measure that is quantified as a total scale score representing an average of the 3 items, with a range from 0-10, with higher scores reflecting more craving. This outcome is the mean score at a single time point, immediately following completion of the intervention.

  immediately after the intervention

Study Arms (2)

Pain De-Catastrophizing

EXPERIMENTAL

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

Behavioral: Pain De-Catastrophizing

Pain Education

PLACEBO COMPARATOR

Brief behavioral education on pain.

Behavioral: Pain Education

Interventions

Pain De-Catastrophizing BEHAVIORAL

Experimenter-administered education and skill practice.

Pain De-Catastrophizing

Pain Education BEHAVIORAL

Experimenter-administered education.

Pain Education

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mclean Hospital: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Kathryn McHugh
• Organization: McLean Hospital

kmchugh@mclean.harvard.edu

617-855-2000

Study Officials

• Rebecca K McHugh, PhD

  Mclean Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The investigator and data analyst will be blind to study condition.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 5, 2019
• First Posted: December 9, 2019
• Study Start: May 4, 2021
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: August 13, 2026
• Results First Posted: August 13, 2026

Record last verified: 2026-08

Locations

US (1)