Stress Response in Opioid Use Disorder

NCT03616379 | Completed Results

• 1 other identifier: 2018P001419
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid-use Disorder

Outcome Measures

Primary Outcomes (2)

• Change in Negative Affect

  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

  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.

  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 Outcomes (3)

• Change in Cortisol Response

  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 Skin Conductance Level

  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 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).

Study Arms (3)

Psychoeducational Control

PLACEBO COMPARATOR

Behavioral: Psychoeducational Control

Affect Regulation Condition

EXPERIMENTAL

Behavioral: Affect Regulation

Affect Labelling Condition

EXPERIMENTAL

Behavioral: Affect Labelling

Interventions

Psychoeducational Control BEHAVIORAL

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.

Psychoeducational Control

Affect Regulation BEHAVIORAL

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.).

Affect Regulation Condition

Affect Labelling BEHAVIORAL

In the Affect Labeling Condition, participants will be provided with instructions for how to verbalize their emotional response during the stressor.

Affect Labelling Condition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• primary diagnosis of opioid use disorder
• ability to read and provide informed consent

You may not qualify if:

• 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)

Sponsors & Collaborators

• Mclean Hospital: lead

Study Sites (1)

McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

Related Publications (2)

• McHugh RK, McCarthy MD, Bichon JA, Nguyen MD, Kneeland EK, Ellis RA, Dillon DG, Fitzmaurice GM. Effects of behavioral interventions on stress reactivity in adults with substance use disorders. Psychol Addict Behav. 2024 Dec;38(8):819-826. doi: 10.1037/adb0001032. Epub 2024 Sep 12.

  PMID: 39264682 DERIVED

• 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.

  PMID: 32833482 DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. R. Kathryn McHugh
• Organization: McLean Hospital

kmchugh@mclean.harvard.edu

617-855-2000

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 5, 2018
• First Posted: August 6, 2018
• Study Start: May 31, 2019
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2022
• Last Updated: April 1, 2024
• Results First Posted: April 1, 2024

Record last verified: 2024-03

Locations

US (1)