- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03616379
Stress Response in Opioid Use Disorder
March 28, 2024 updated by: McHugh, R. Kathryn, Mclean Hospital
Behavioral Strategies to Reduce Stress Reactivity in Opioid Use Disorder
Opioid use disorder is a major public health problem.
Although there are effective treatments for this disorder, many people still relapse and thus there is a need for new treatments to improve outcomes.
People who have a strong emotional and physical response to stress are at a higher risk of relapse.
The goal of this project is to test the effect of strategies to reduce response to stress in people diagnosed with opioid use disorder.
Men and women diagnosed with opioid use disorder will be recruited for a one-session study.
Participants will be randomly assigned to one of three brief instructional conditions followed by a brief laboratory stress test.
Investigators hypothesize that, compared to education about stress, brief strategies to help people cope with negative emotions will reduce responses to stress and increase tolerance of stress.
If this hypothesis is supported, it will inform the development of new treatments to improve outcome in opioid use disorder.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
119
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: R. Kathryn McHugh, PhD
- Phone Number: 617-855-3169
- Email: kmchugh@mclean.harvard.edu
Study Locations
-
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Massachusetts
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Belmont, Massachusetts, United States, 02478
- McLean Hospital
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-
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:
- 18 years or older
- primary diagnosis of opioid use disorder
- ability to read and provide informed consent
Exclusion Criteria:
- major psychiatric or medical condition that would interfere with the ability to complete study procedures
- current opioid withdrawal
- presence of another current substance use disorder at a severity requiring acute treatment
- endocrine disease or current steroid prescription
- opioid-positive urine drug screen or breath alcohol test on the data or enrollment (not including prescribed medications)
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 |
---|---|
Placebo Comparator: Psychoeducational Control
|
The Psychoeducational Control condition will consist of a brief script describing the body's response to stress and will not discuss cognition or the role of interpretation or affect labeling during stress.
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Experimental: Affect Regulation Condition
|
In the Affect Regulation Condition, participants will be provided instructions for how to reappraise negative thoughts in the context of stress by developing statements consistent with more benign interpretations of stress (e.g., This won't last forever.).
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Experimental: Affect Labelling Condition
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In the Affect Labeling Condition, participants will be provided with instructions for how to verbalize their emotional response during the stressor.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Negative Affect
Time Frame: Change measured over 2 time points during this 1-session study experiment (from start of a stress induction task to completion; approximately 10-15 minutes).
|
Negative affect will be measured using the Negative Affect Subscale of the Positive and Negative Affect Schedule.
This is a 10-item self-report measure on which respondents rate how strongly they are experiencing negative emotion.
The range of scores is 10-50, with higher scores representing higher negative affect.
|
Change measured over 2 time points during this 1-session study experiment (from start of a stress induction task to completion; approximately 10-15 minutes).
|
Distress Tolerance
Time Frame: Time-to-event outcome; during this 1-session study, this will measure time to outcome (discontinuation of task) from time of initiation of the stress induction task up to a maximum of 15 minutes later.
|
Distress tolerance will be measured using the Computerized Mirror Tracing Persistence Task.
This is a computer-based task in which participants trace a mirror on the screen using the cursor.
Participants are asked to persist at the task for as long as possible.
Time to discontinuation is used as a measure of distress tolerance (in seconds).
Longer duration reflects better tolerance of distress.
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Time-to-event outcome; during this 1-session study, this will measure time to outcome (discontinuation of task) from time of initiation of the stress induction task up to a maximum of 15 minutes later.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Skin Conductance Level
Time Frame: Change measured over 2 time points during this 1-session study (prior to and during the stress induction task; approximately 10-15 minutes).
|
Skin conductance level is a physiological outcome that will be measured using electrodes placed on participants fingers, connected to a Biopac MP150 system with an ECG amplifier.
Change will be measures by subtracting the maximum value during the stress task from the value at the end of a baseline recording.
|
Change measured over 2 time points during this 1-session study (prior to and during the stress induction task; approximately 10-15 minutes).
|
Change in Cortisol Response
Time Frame: Change measured over 2 time points during this 1-session study (from start of stress induction task to 30 minutes after completion; approximately 40-45 minutes).
|
Cortisol levels will be measured using saliva samples.
Salivary cortisol levels are measured on a continuous scale (micrograms/deciliter).
|
Change measured over 2 time points during this 1-session study (from start of stress induction task to 30 minutes after completion; approximately 40-45 minutes).
|
Change in Opioid Craving
Time Frame: Change measured over 2 time points during this 1-session study (immediately prior to and at the completion of the stress induction task; approximately 10-15 minutes).
|
Self-report of opioid craving will be measured using the Opioid Craving Scale, a 3-item measure, with a range of 0-30, with higher scores representing strong opioid craving.
|
Change measured over 2 time points during this 1-session study (immediately prior to and at the completion of the stress induction task; approximately 10-15 minutes).
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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 31, 2019
Primary Completion (Actual)
August 31, 2022
Study Completion (Actual)
August 31, 2022
Study Registration Dates
First Submitted
July 5, 2018
First Submitted That Met QC Criteria
August 3, 2018
First Posted (Actual)
August 6, 2018
Study Record Updates
Last Update Posted (Actual)
April 1, 2024
Last Update Submitted That Met QC Criteria
March 28, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018P001419
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
In accordance with NIH policies for data sharing, data resulting from this project will be made available to qualified individuals within the scientific community.
By data, this means the recorded, factual material necessary to document and support the research findings.
Data will first be checked in accordance with the Data Safety and Monitoring Plan to ensure accuracy and completeness.
To comply with pertinent local and federal regulations regarding the confidentiality of research data, any shared data would be free of identifiers that would permit linkage to research participants, and free of content that would create unacceptably high risks of subject identification.
Data will be available to other researchers upon request to the study PI through a data sharing agreement after the primary paper has been accepted for publication in compliance with the NIH policy for the timely release and sharing of data.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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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