Stress Response in Opioid Use Disorder

• ClinicalTrials.gov Identifier: NCT03616379
• Recruitment Status: Recruiting
• First Posted: August 6, 2018
• Last Update Posted: August 26, 2021
• Sponsor: Mclean Hospital
• Information provided by (Responsible Party): McHugh, R. Kathryn, Mclean Hospital

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Opioid-use Disorder	Behavioral: Psychoeducational Control; Behavioral: Affect Regulation; Behavioral: Affect Labelling	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Masking Description: The study PI and data analyst will be blind to study condition. The experimenter will and participant will be aware of the study condition because this is a behavioral intervention.
• Primary Purpose: Other
• Official Title: Behavioral Strategies to Reduce Stress Reactivity in Opioid Use Disorder
• Actual Study Start Date: May 31, 2019
• Estimated Primary Completion Date: May 31, 2022
• Estimated Study Completion Date: July 31, 2022

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Psychoeducational Control	Behavioral: 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.
Experimental: Affect Regulation Condition	Behavioral: Affect Regulation; 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.).
Experimental: Affect Labelling Condition	Behavioral: Affect Labelling; In the Affect Labeling Condition, participants will be provided with instructions for how to verbalize their emotional response during the stressor.

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.

Secondary Outcome Measures :

1. 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 in the unit of micrograms/deciliter.
2. 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.
3. Change in Opioid Craving [ 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). ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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)

Contacts and Locations

Contacts

Contact: R. Kathryn McHugh, PhD; 617-855-3169; kmchugh@mclean.harvard.edu

Locations

United States, Massachusetts

McLean Hospital; Recruiting

Belmont, Massachusetts, United States, 02478

Contact: Rebecca K McHugh, PhD

Principal Investigator: Rebecca K McHugh, PhD

Sponsors and Collaborators

Mclean Hospital

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

McHugh RK, Nguyen MD, Fitzmaurice GM, Dillon DG. Behavioral strategies to reduce stress reactivity in opioid use disorder: Study design. Health Psychol. 2020 Sep;39(9):806-814. doi: 10.1037/hea0000862.

• Responsible Party: McHugh, R. Kathryn, Assistant Professor, Mclean Hospital
• ClinicalTrials.gov Identifier: NCT03616379
• Other Study ID Numbers: 2018P001419
• First Posted: August 6, 2018
• Last Update Posted: August 26, 2021
• Last Verified: August 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided
• 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.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

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