Clinical trial NCT06954402: Resilience Among Individuals With Opioid Use Disorder
Official title: A Novel Human Laboratory Model of Resilience Among Individuals With Opioid Use Disorder
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Opioid Use Disorder
Keywords: opioids
opioid use disorder
stress
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2025-05-01
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Self-Reported Trait Resilience as assessed by Connor-Davidson Resilience Scale 25 (CD-RISC-25)
timeFrame: Immediately after completing the task
measure: Cognitive Flexibility: Stroop Color-Word Test reaction time
timeFrame: Immediately after completing the task
measure: Emotional Flexibility: Emotional Stroop Task reaction time
timeFrame: Immediately after completing the task
measure: Perceived Controllability (Controllable) assessed by Social Controllability Task (SCT)
timeFrame: Immediately after completing the task
Secondary outcomes:
measure: Subjective Effects of Stress as assessed by the Subjective Effects Visual Analog Scale (VAS) Battery
timeFrame: Immediately after completing the task
measure: Heart Rate
timeFrame: Immediately after completing the task
measure: Systolic Blood Pressure
timeFrame: Immediately after completing the task
measure: Diastolic Blood Pressure
timeFrame: Immediately after completing the task
measure: Opioid Demand Breakpoint as assessed by the Hypothetical Purchase Task
timeFrame: Immediately after completing the task
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University Bayview Medical Campus
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Suky Martinez, PhD
role: PRINCIPAL_INVESTIGATOR
References: