An interventional study of Acute Stress Intervention (MAST-based) and Non-Stress Intervention (NST-based) in Opioid Use Disorder, sponsored by Johns Hopkins University. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-23.
Sponsored by Johns Hopkins University · Not applicable, Interventional, and Basic science
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.
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.
1,411 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.
This study's planned enrollment of 125 is above the median of 63 across 1,123 interventional studies indexed under Opioid-Related Disorders.
Browse Opioid-Related Disorders studies →Johns Hopkins University is the lead sponsor of 1,783 studies on the registry; 313 are open to participants now.
Of its 203 completed or terminated interventional studies of FDA-regulated products, 140 (69%) have results posted.
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Exclusion Criteria:
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) · Behavioral: Non-Stress Intervention (NST-based)
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) · Behavioral: Non-Stress Intervention (NST-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.
In this control intervention, participants complete the same battery of laboratory tasks without exposure to the acute stressor.
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.
Time frame: 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)
Time frame: 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).
Time frame: 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.
Time frame: Immediately after completing the task
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.
Time frame: Immediately after completing the task
Heart Rate
Unit: Beats per minute (bpm) Interpretation: Higher = increased arousal
Time frame: Immediately after completing the task
Systolic Blood Pressure
Unit: mmHg Interpretation: Higher = greater pressure.
Time frame: Immediately after completing the task
Diastolic Blood Pressure
Unit: mmHg Interpretation: Higher = greater pressure.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From baseline up to 1 year
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