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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

About this trial

This is an interventional other trial for Opioid-use Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

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

Time Frame

30 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

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

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Pain, Inflammation and Opioid Craving

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