CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 119 enrolled
Drug / intervention
Psychoeducational Control +2 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03616379
NCT03616379N/ACompleted

Behavioral Strategies to Reduce Stress Reactivity in Opioid Use Disorder

Mclean Hospital·interventional·Posted Aug 6, 2018·Updated Apr 1, 2024

In Brief

A clinical study evaluating Psychoeducational Control, Affect Regulation, and 1 other intervention for Opioid-use Disorder. Completed, enrolled 119 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedAug 6, 2018
Enrollment StartMay 31, 2019
Primary CompletionAug 31, 2022
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 7.9 years ago

Interventions

Psychoeducational Controlbehavioral

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 Regulationbehavioral

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 Labellingbehavioral

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