Resilience Among Individuals With Opioid Use Disorder
ConditionOpioid Use Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJohns Hopkins University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Being pregnant or breastfeeding
Significant mental health or physical disorder, or life circumstances, that is judged by the investigators to interfere with study participation
Trial design
Design model
Crossover
Treatments tested in this trial
Acute Stress Intervention (MAST-based)
BehavioralThis 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.
Non-Stress Intervention (NST-based)
BehavioralIn this control intervention, participants complete the same battery of laboratory tasks without exposure to the acute stressor.
Treatment groups
125 Participants
are divided into 2 treatment groupsGroup A: Stress-First SequenceExperimental treatment 2 interventions
Group B: Non-Stress-First SequenceExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Self-Reported Trait Resilience as assessed by Connor-Davidson Resilience Scale 25 (CD-RISC-25)
Instrument: Connor-Davidson Resilience Scale 25 Score Range: 0-100 Interpretation: Higher scores indicate greater resilience.
Time frame
Immediately after completing the task2
Cognitive Flexibility: Stroop Color-Word Test reaction time
Instrument: Stroop Color-Word Test Unit: Milliseconds (ms) Interpretation: Higher values = slower performance (worse)
Time frame
Immediately after completing the task3
Emotional Flexibility: Emotional Stroop Task reaction time
Instrument: Emotional Stroop Task Unit: Milliseconds (ms) Interpretation: Higher values = slower performance (worse).
Time frame
Immediately after completing the task4
Perceived Controllability (Controllable) assessed by Social Controllability Task (SCT)
Instrument: Social Controllability Task Description: Participants ratings on a 0-100% sliding scale. Interpretation: Higher scores indicate greater perceived control.
Time frame
Immediately after completing the taskSecondary outcomes
1
Subjective Effects of Stress as assessed by the Subjective Effects Visual Analog Scale (VAS) Battery
Instrument: Subjective Effects Visual Analog Scale (VAS) Battery Instrument: VAS (0-100 mm) Interpretation: Higher scores indicate greater intensity of each subjective state.
Time frame
Immediately after completing the task2
Heart Rate
Unit: Beats per minute (bpm) Interpretation: Higher = increased arousal
Time frame
Immediately after completing the task3
Systolic Blood Pressure
Unit: mmHg Interpretation: Higher = greater pressure.
Time frame
Immediately after completing the task4
Diastolic Blood Pressure
Unit: mmHg Interpretation: Higher = greater pressure.
Time frame
Immediately after completing the taskSponsors and contacts
Click on the lead sponsor to view all of their trials.
Johns Hopkins University
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
Source ClinicalTrials.gov