Resilience Among Individuals With Opioid Use Disorder

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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.
• Поведенческое Non-Stress Intervention (NST-based)
  In this control intervention, participants complete the same battery of laboratory tasks without exposure to the acute stressor.

Первичные конечные точки

• Self-Reported Trait Resilience as assessed by Connor-Davidson Resilience Scale 25 (CD-RISC-25) [Срок оценки: Immediately after completing the task]
• Cognitive Flexibility: Stroop Color-Word Test reaction time [Срок оценки: Immediately after completing the task]
• Emotional Flexibility: Emotional Stroop Task reaction time [Срок оценки: Immediately after completing the task]
• Perceived Controllability (Controllable) assessed by Social Controllability Task (SCT) [Срок оценки: Immediately after completing the task]

Вторичные конечные точки (9)

• Subjective Effects of Stress as assessed by the Subjective Effects Visual Analog Scale (VAS) Battery [Срок оценки: Immediately after completing the task]
• Heart Rate [Срок оценки: Immediately after completing the task]
• Systolic Blood Pressure [Срок оценки: Immediately after completing the task]
• Diastolic Blood Pressure [Срок оценки: Immediately after completing the task]
• Opioid Demand Breakpoint as assessed by the Hypothetical Purchase Task [Срок оценки: Immediately after completing the task]
• Percentage of Resilience-themed Interview Content [Срок оценки: Up to 1 year]
• Percentage of Spirituality-themed Interview Content [Срок оценки: Up to 1 year]
• Mean Narrative Sentiment Valence Score [Срок оценки: Up to 1 year]
• Incremental Variance (∆R2) in Stress-Induced Opioid Demand Predicted by NLP Indices [Срок оценки: From baseline up to 1 year]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• Being pregnant or breastfeeding
• Significant mental health or physical disorder, or life circumstances, that is judged by the investigators to interfere with study participation

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

США · 2 центра

• Johns Hopkins University Bayview Medical Campus — Baltimore
• Johns Hopkins University Bayview Medical Campus — Baltimore

Идентификаторы

NCT: NCT06954402 · IRB00438915 · K08DA058057

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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