Stress Response in Opioid Use Disorder

NCT03616379 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 119

Last updated 2024-04-01

Study results available
· View outcomes & findings →

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

Interventions

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.

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.).

BEHAVIORAL

Affect Labelling

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

Sponsors & Collaborators

  • Mclean Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-31
Primary Completion
2022-08-31
Completion
2022-08-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03616379 on ClinicalTrials.gov