Resilience Among Individuals With Opioid Use Disorder

Not Applicable

Not yet recruiting

• Conditions: Opioid Use Disorder

• Registration Number: NCT06954402
• Lead Sponsor: Johns Hopkins University

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.

Study Timeline

• Study First Submitted: 2025-04-24
• Study First Submitted QC: 2025-04-24
• Status Verified: 2025-05
• Study First Posted: 2025-05-01
• Last Update Submitted: 2025-05-01
• Last Update Posted: 2025-05-02
• Study Start: 2025-07-01
• Primary Completion: 2029-04-30
• Study Completion: 2029-04-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 125

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Self-Reported Trait Resilience as assessed by Connor-Davidson Resilience Scale 25 (CD-RISC-25)	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	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	Immediately after completing the task	Instrument: Emotional Stroop Task Unit: Milliseconds (ms) Interpretation: Higher values = slower performance (worse).
Perceived Controllability (Controllable) assessed by Social Controllability Task (SCT)	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.

Secondary Outcome Measures

Name	Time	Method
Subjective Effects of Stress as assessed by the Subjective Effects Visual Analog Scale (VAS) Battery	Immediately after completing the task	Instrument: Subjective Effects Visual Analog Scale (VAS) Battery Instrument: VAS (0-100 mm) Interpretation: Higher scores indicate greater intensity of each subjective state.
Heart Rate	Immediately after completing the task	Unit: Beats per minute (bpm) Interpretation: Higher = increased arousal
Systolic Blood Pressure	Immediately after completing the task	Unit: mmHg Interpretation: Higher = greater pressure.
Diastolic Blood Pressure	Immediately after completing the task	Unit: mmHg Interpretation: Higher = greater pressure.
Opioid Demand Breakpoint as assessed by the Hypothetical Purchase Task	Immediately after completing the task	Instrument: Hypothetical Purchase Task Range: $0-$500 Interpretation: Higher = greater demand.

Trial Locations

Locations (1)

Johns Hopkins University Bayview Medical Campus; 🇺🇸 Baltimore, Maryland, United States