Resilience Among Individuals With Opioid Use Disorder

NCT ID: NCT06954402

Last Updated: 2026-01-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 125 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-04-30
• Study Completion Date: 2029-04-30

Brief Summary

The goal of this clinical trial is to develop a human laboratory model of resilience in people with opioid use disorder (OUD). The investigators aim to learn if objective tasks that measure cognitive, emotional, and control aspects of resilience match up with self-reported resilience during stress and non-stress situations.

Detailed Description

This study is an outpatient, within-subject, randomized controlled trial designed to develop and validate a novel laboratory-based model for assessing resilience in individuals with opioid use disorder (OUD). The study employs a dual-condition design where participants complete two experimental sessions administered in a randomized order: one under a stress condition and under a non-stress condition. In each session, participants will perform a series of standardized laboratory tasks aimed at evaluating cognitive, emotional, and control aspects of resilience. Objective measures (e.g., task performance data and physiological indices) and subjective ratings of stress reactivity will be collected to capture both behavioral and self-perceived responses.

Conditions

Opioid Use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Stress-First Sequence

Participants in this arm will first undergo the stress condition using the Maastricht Acute Stress Test (MAST) and then complete the non-stress condition (NST) in a subsequent session.

Group Type: EXPERIMENTAL

Acute Stress Intervention (MAST-based)

Intervention Type: BEHAVIORAL

This intervention uses the Maastricht Acute Stress Test (MAST) to induce an acute stress response. Participants are exposed to standardized stress tasks while performing laboratory-based assessments of cognitive, emotional, and control aspects of resilience.

Non-Stress Intervention (NST-based)

Intervention Type: BEHAVIORAL

In this control intervention, participants complete the same battery of laboratory tasks without exposure to the acute stressor.

Non-Stress-First Sequence

Participants in this arm will first complete the non-stress condition (NST) and then undergo the stress condition using the Maastricht Acute Stress Test (MAST) in a subsequent session.

Group Type: EXPERIMENTAL

Acute Stress Intervention (MAST-based)

Intervention Type: BEHAVIORAL

This intervention uses the Maastricht Acute Stress Test (MAST) to induce an acute stress response. Participants are exposed to standardized stress tasks while performing laboratory-based assessments of cognitive, emotional, and control aspects of resilience.

Non-Stress Intervention (NST-based)

Intervention Type: BEHAVIORAL

In this control intervention, participants complete the same battery of laboratory tasks without exposure to the acute stressor.

Interventions

Acute Stress Intervention (MAST-based)

This intervention uses the Maastricht Acute Stress Test (MAST) to induce an acute stress response. Participants are exposed to standardized stress tasks while performing laboratory-based assessments of cognitive, emotional, and control aspects of resilience.

Intervention Type: BEHAVIORAL

Non-Stress Intervention (NST-based)

In this control intervention, participants complete the same battery of laboratory tasks without exposure to the acute stressor.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Can provide informed consent and can comply with study procedures

2. Adults aged ≥18 years

3. Meet Diagnostic and Statistical Manual (DSM-5) criteria for current opioid use disorder or are currently receiving pharmacotherapy for the treatment of OUD (e.g. methadone or buprenorphine maintenance treatment [remission])

4. Urine sample that tests positive for opioids

5. Test negative for pregnancy at screening (females only)

Exclusion Criteria

1. Being pregnant or breastfeeding

2. Significant mental health or physical disorder, or life circumstances, that is judged by the investigators to interfere with study participation

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Suky Martinez, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins University Bayview Medical Campus

Baltimore, Maryland, United States

Countries

United States

Central Contacts

Suky Martinez, PhD

Role: CONTACT

smart209@jh.edu

410-550-0007

Other Identifiers

K08DA058057

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00438915

Identifier Type: -

Identifier Source: org_study_id