Stress Response in Opioid Use Disorder

Opioid-use Disorder Clinical Trial

Official title:

Behavioral Strategies to Reduce Stress Reactivity in Opioid Use Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03616379
• Other study ID #: 2018P001419
• Status: Completed
• Phase: N/A
• Start date: May 31, 2019
• Est. completion date: August 31, 2022

Study information

• Verified date: March 2024
• Source: Mclean Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: August 31, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Opioid-Related Disorders
• Opioid-use Disorder
• Substance-Related Disorders

Intervention

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

Locations

Country	Name	City	State
United States	McLean Hospital	Belmont	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Mclean Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Primary	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	Change in Cortisol Response	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).
Secondary	Change in Skin Conductance Level	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).
Secondary	Change in Opioid Craving	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).