Resilience Among Individuals With Opioid Use Disorder

Johns Hopkins University

Status: Begins enrollment in 2 months

Conditions: Opioid Use Disorder

Treatments: Behavioral: Acute Stress Intervention (MAST-based); Behavioral: Non-Stress Intervention (NST-based)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06954402

K08DA058057 (U.S. NIH Grant/Contract)

IRB00438915

Details and patient eligibility

About

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.

Full 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.

Enrollment: 125 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

125 participants in 2 patient groups

Stress-First Sequence

Experimental group

Description:

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.

Treatment:

Behavioral: Non-Stress Intervention (NST-based)

Behavioral: Acute Stress Intervention (MAST-based)

Non-Stress-First Sequence

Experimental group

Description:

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.

Treatment:

Behavioral: Non-Stress Intervention (NST-based)

Behavioral: Acute Stress Intervention (MAST-based)