Stress Response in Opioid Use Disorder

NCT ID: NCT03616379

Last Updated: 2024-04-01

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

119 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-31

Study Completion Date

2022-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Opioid-use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Investigators
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.

Study Groups

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Psychoeducational Control

Group Type PLACEBO_COMPARATOR

Psychoeducational Control

Intervention Type 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 Condition

Group Type EXPERIMENTAL

Affect Regulation

Intervention Type 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 Condition

Group Type EXPERIMENTAL

Affect Labelling

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type 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.).

Intervention Type BEHAVIORAL

Affect Labelling

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mclean Hospital

OTHER

Sponsor Role lead

Responsible Party

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McHugh, R. Kathryn

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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McLean Hospital

Belmont, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 39264682 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32833482 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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2018P001419

Identifier Type: -

Identifier Source: org_study_id

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