- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04190563
Pain, Inflammation and Opioid Craving
January 25, 2024 updated by: McHugh, R. Kathryn, Mclean Hospital
Affective and Inflammatory Reactivity to Pain in Opioid Use Disorder
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Rebecca K McHugh, PhD
- Phone Number: 617-855-2000
- Email: kmchugh@mclean.harvard.edu
Study Locations
-
-
Massachusetts
-
Belmont, Massachusetts, United States, 02478
- Recruiting
- McLean Hospital
-
Principal Investigator:
- Rebecca K McHugh, PhD
-
Contact:
- Rebecca McHugh
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pain De-Catastrophizing
Brief behavioral education on how to modify the interpretation of pain.
|
Experimenter-administered education and skill practice.
|
Placebo Comparator: Pain Education
Brief behavioral education on pain.
|
Experimenter-administered education.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
30 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Rebecca K McHugh, PhD, McLean Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 4, 2021
Primary Completion (Estimated)
May 31, 2025
Study Completion (Estimated)
July 15, 2025
Study Registration Dates
First Submitted
December 5, 2019
First Submitted That Met QC Criteria
December 5, 2019
First Posted (Actual)
December 9, 2019
Study Record Updates
Last Update Posted (Estimated)
January 26, 2024
Last Update Submitted That Met QC Criteria
January 25, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019P002720
- R01DA045632 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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