A Novel Human Laboratory Model of Resilience Among Individuals With Opioid Use Disorder
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Johns Hopkins University
- Enrollment
- 125
- Locations
- 2
- Primary Endpoint
- Perceived Controllability (Controllable) assessed by Social Controllability Task (SCT)
Study Overview
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 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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Non-Stress Intervention (NST-based) (Behavioral)
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.
Intervention: Acute Stress Intervention (MAST-based) (Behavioral)
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.
Intervention: Non-Stress Intervention (NST-based) (Behavioral)
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.
Intervention: Acute Stress Intervention (MAST-based) (Behavioral)
Outcomes
Primary Outcomes
Perceived Controllability (Controllable) assessed by Social Controllability Task (SCT)
Time Frame: Immediately after completing the task
Instrument: Social Controllability Task Description: Participants ratings on a 0-100% sliding scale. Interpretation: Higher scores indicate greater perceived control.
Self-Reported Trait Resilience as assessed by Connor-Davidson Resilience Scale 25 (CD-RISC-25)
Time Frame: Immediately after completing the task
Instrument: Connor-Davidson Resilience Scale 25 Score Range: 0-100 Interpretation: Higher scores indicate greater resilience.
Cognitive Flexibility: Stroop Color-Word Test reaction time
Time Frame: Immediately after completing the task
Instrument: Stroop Color-Word Test Unit: Milliseconds (ms) Interpretation: Higher values = slower performance (worse)
Emotional Flexibility: Emotional Stroop Task reaction time
Time Frame: Immediately after completing the task
Instrument: Emotional Stroop Task Unit: Milliseconds (ms) Interpretation: Higher values = slower performance (worse).
Secondary Outcomes
- Percentage of Resilience-themed Interview Content(Up to 1 year)
- Percentage of Spirituality-themed Interview Content(Up to 1 year)
- Mean Narrative Sentiment Valence Score(Up to 1 year)
- Incremental Variance (∆R2) in Stress-Induced Opioid Demand Predicted by NLP Indices(From baseline up to 1 year)
- Subjective Effects of Stress as assessed by the Subjective Effects Visual Analog Scale (VAS) Battery(Immediately after completing the task)
- Heart Rate(Immediately after completing the task)
- Systolic Blood Pressure(Immediately after completing the task)
- Diastolic Blood Pressure(Immediately after completing the task)
- Opioid Demand Breakpoint as assessed by the Hypothetical Purchase Task(Immediately after completing the task)