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OpenTrials
Completed

NCT Number: NCT03616379

Stress Response 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.

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Key information

Conditions

Opioid-use Disorder Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

McLean Hospital

Belmont, Massachusetts, 02478, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

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 Labelling

Behavioral

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

Primary outcomes

  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 outcomes

  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 (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 (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.

Sponsors and collaborators

Lead sponsor

Mclean Hospital

Other

Registry information

Official study title

Behavioral Strategies to Reduce Stress Reactivity in Opioid Use Disorder

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Aug 6, 2018
Registry last updated
Apr 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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