Resilience Among Individuals With Opioid Use Disorder

A Novel Human Laboratory Model of Resilience Among Individuals With Opioid Use Disorder

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.

Study Overview

• Status: Recruiting
• Conditions: Opioid Use Disorder
• Intervention / Treatment: Behavioral: Acute Stress Intervention (MAST-based); Behavioral: Non-Stress Intervention (NST-based)

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 one 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.

Additionally, this study includes an administrative supplement focused on Natural Language Processing (NLP) phenotyping. A subset of participants who complete the primary human laboratory resilience assessments will participate in a semi-structured qualitative interview probing personal definitions and experiences of resilience and spirituality. The resulting narratives will be analyzed using AI and NLP methods to derive quantitative linguistic indices. These indices will be integrated with the parent study's behavioral and physiological data to determine if narrative markers of spirituality and resilience improve the prediction of stress-induced opioid demand and refine mechanistic models of OUD.

• Study Type: Interventional
• Enrollment (Estimated): 125
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Suky Martinez, PhD; Phone Number: 410-550-0007; Email: smart209@jh.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Recruiting
      • Johns Hopkins University Bayview Medical Campus
      • Contact: Alec Zhang, BS; Phone Number: 410-550-4121; Email: smart209@jh.edu
    • Baltimore, Maryland, United States, 21224
      • Not yet recruiting
      • Johns Hopkins University Bayview Medical Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.; Behavioral: Non-Stress Intervention (NST-based); In this control intervention, participants complete the same battery of laboratory tasks without exposure to the acute stressor.
Experimental: 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.	Behavioral: 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.; Behavioral: Non-Stress Intervention (NST-based); In this control intervention, participants complete the same battery of laboratory tasks without exposure to the acute stressor.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-Reported Trait Resilience as assessed by Connor-Davidson Resilience Scale 25 (CD-RISC-25)	Instrument: Connor-Davidson Resilience Scale 25 Score Range: 0-100 Interpretation: Higher scores indicate greater resilience.	Immediately after completing the task
Cognitive Flexibility: Stroop Color-Word Test reaction time	Instrument: Stroop Color-Word Test Unit: Milliseconds (ms) Interpretation: Higher values = slower performance (worse)	Immediately after completing the task
Emotional Flexibility: Emotional Stroop Task reaction time	Instrument: Emotional Stroop Task Unit: Milliseconds (ms) Interpretation: Higher values = slower performance (worse).	Immediately after completing the task
Perceived Controllability (Controllable) assessed by Social Controllability Task (SCT)	Instrument: Social Controllability Task Description: Participants ratings on a 0-100% sliding scale. Interpretation: Higher scores indicate greater perceived control.	Immediately after completing the task

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective Effects of Stress as assessed by the Subjective Effects Visual Analog Scale (VAS) Battery	Instrument: Subjective Effects Visual Analog Scale (VAS) Battery Instrument: VAS (0-100 mm) Interpretation: Higher scores indicate greater intensity of each subjective state.	Immediately after completing the task
Heart Rate	Unit: Beats per minute (bpm) Interpretation: Higher = increased arousal	Immediately after completing the task
Systolic Blood Pressure	Unit: mmHg Interpretation: Higher = greater pressure.	Immediately after completing the task
Diastolic Blood Pressure	Unit: mmHg Interpretation: Higher = greater pressure.	Immediately after completing the task
Opioid Demand Breakpoint as assessed by the Hypothetical Purchase Task	Instrument: Hypothetical Purchase Task Range: $0-$500 Interpretation: Higher = greater demand.	Immediately after completing the task
Percentage of Resilience-themed Interview Content	This outcome is defined as the average percentage of narrative content within semi-structured qualitative interviews classified as "resilience-themed" using Latent Dirichlet Allocation (LDA). This measure quantifies the relative focus a participant places on adaptive coping and recovery narratives	Up to 1 year
Percentage of Spirituality-themed Interview Content	This outcome is defined as the average percentage of narrative content within semi-structured qualitative interviews classified as "spirituality-themed" using Latent Dirichlet Allocation (LDA). This measure quantifies the relative focus a participant places on spiritual or existential frameworks as a component of their recovery.	Up to 1 year
Mean Narrative Sentiment Valence Score	A quantitative emotional-tone score calculated from participant interview transcripts using a standardized sentiment analysis algorithm. The score range is -1 to +1. A score of -1 represents a highly negative emotional valence, while a score of +1 represents a highly positive emotional valence. Higher scores indicate a more positive emotional narrative.	Up to 1 year
Incremental Variance (∆R2) in Stress-Induced Opioid Demand Predicted by NLP Indices	This outcome measures the change in R-squared (∆R2) when NLP-derived indices (topic proportions and sentiment) are added to a sequential regression model that already includes self-report and behavioral task scores. This measurement will be performed only on the subset of 45 participants who complete the qualitative interview sub-study. The outcome being predicted is the difference in opioid purchase breakpoints between the stress (MAST) and no-stress conditions.	From baseline up to 1 year

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Suky Martinez, PhD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Estimated): May 29, 2026
• Primary Completion (Estimated): April 30, 2029
• Study Completion (Estimated): April 30, 2029

Study Registration Dates

• First Submitted: April 24, 2025
• First Submitted That Met QC Criteria: April 24, 2025
• First Posted (Actual): May 1, 2025

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: stress; opioid use disorder; opioids
• Additional Relevant MeSH Terms: Narcotic-Related Disorders; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Opioid-Related Disorders
• Other Study ID Numbers: IRB00438915; K08DA058057 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No