Pain, Inflammation and Opioid Craving
Primary Purpose
Opioid-use Disorder
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pain De-Catastrophizing
Pain Education
Sponsored by
About this trial
This is an interventional other trial for Opioid-use Disorder
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
Sites / Locations
- McLean HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Pain De-Catastrophizing
Pain Education
Arm Description
Brief behavioral education on how to modify the interpretation of pain.
Brief behavioral education on pain.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04190563
First Posted
December 5, 2019
Last Updated
July 3, 2023
Sponsor
Mclean Hospital
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT04190563
Brief Title
Pain, Inflammation and Opioid Craving
Official Title
Affective and Inflammatory Reactivity to Pain in Opioid Use Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 4, 2021 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
July 15, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mclean Hospital
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-use Disorder
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Masking Description
The investigator and data analyst will be blind to study condition.
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pain De-Catastrophizing
Arm Type
Experimental
Arm Description
Brief behavioral education on how to modify the interpretation of pain.
Arm Title
Pain Education
Arm Type
Placebo Comparator
Arm Description
Brief behavioral education on pain.
Intervention Type
Behavioral
Intervention Name(s)
Pain De-Catastrophizing
Intervention Description
Experimenter-administered education and skill practice.
Intervention Type
Behavioral
Intervention Name(s)
Pain Education
Intervention Description
Experimenter-administered education.
Primary Outcome Measure Information:
Title
Craving
Description
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.
Time Frame
30 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rebecca K McHugh, PhD
Phone
617-855-2000
Email
kmchugh@mclean.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca K McHugh, PhD
Organizational Affiliation
Mclean Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
McLean Hospital
City
Belmont
State/Province
Massachusetts
ZIP/Postal Code
02478
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rebecca McHugh
First Name & Middle Initial & Last Name & Degree
Rebecca K McHugh, PhD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Pain, Inflammation and Opioid Craving
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