Resilience Among Individuals With Opioid Use Disorder
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Acute Stress Intervention (MAST-based), Non-Stress Intervention (NST-based).
- Who it may be relevant to
- Registry conditions: Opioid Use Disorder. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Novel Human Laboratory Model of Resilience Among Individuals With Opioid Use Disorder
Overview
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 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.
Interventions
- 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.
Primary outcome measures
- Self-Reported Trait Resilience as assessed by Connor-Davidson Resilience Scale 25 (CD-RISC-25) [Time frame: Immediately after completing the task]
- Cognitive Flexibility: Stroop Color-Word Test reaction time [Time frame: Immediately after completing the task]
- Emotional Flexibility: Emotional Stroop Task reaction time [Time frame: Immediately after completing the task]
- Perceived Controllability (Controllable) assessed by Social Controllability Task (SCT) [Time frame: Immediately after completing the task]
Secondary outcome measures (9)
- Subjective Effects of Stress as assessed by the Subjective Effects Visual Analog Scale (VAS) Battery [Time frame: Immediately after completing the task]
- Heart Rate [Time frame: Immediately after completing the task]
- Systolic Blood Pressure [Time frame: Immediately after completing the task]
- Diastolic Blood Pressure [Time frame: Immediately after completing the task]
- Opioid Demand Breakpoint as assessed by the Hypothetical Purchase Task [Time frame: Immediately after completing the task]
- Percentage of Resilience-themed Interview Content [Time frame: Up to 1 year]
- Percentage of Spirituality-themed Interview Content [Time frame: Up to 1 year]
- Mean Narrative Sentiment Valence Score [Time frame: Up to 1 year]
- Incremental Variance (∆R2) in Stress-Induced Opioid Demand Predicted by NLP Indices [Time frame: From baseline up to 1 year]
Eligibility criteria
Inclusion criteria
- Can provide informed consent and can comply with study procedures
- Adults aged ≥18 years
- 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 \[remission\])
- Urine sample that tests positive for opioids
- Test negative for pregnancy at screening (females only)
Exclusion criteria
- Being pregnant or breastfeeding
- Significant mental health or physical disorder, or life circumstances, that is judged by the investigators to interfere with study participation
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
United States · 2 centers
- Johns Hopkins University Bayview Medical Campus — Baltimore
- Johns Hopkins University Bayview Medical Campus — Baltimore
Identifiers
NCT: NCT06954402 · IRB00438915 · K08DA058057