Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 3:00 AM
Study NCT ID:
NCT06954402
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-30
First Post:
2025-04-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Resilience Among Individuals With Opioid Use Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009293', 'term': 'Opioid-Related Disorders'}], 'ancestors': [{'id': 'D000079524', 'term': 'Narcotic-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 125}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-29', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2029-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-29', 'studyFirstSubmitDate': '2025-04-24', 'studyFirstSubmitQcDate': '2025-04-24', 'lastUpdatePostDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Self-Reported Trait Resilience as assessed by Connor-Davidson Resilience Scale 25 (CD-RISC-25)', 'timeFrame': 'Immediately after completing the task', 'description': 'Instrument: Connor-Davidson Resilience Scale 25 Score Range: 0-100 Interpretation: Higher scores indicate greater resilience.'}, {'measure': 'Cognitive Flexibility: Stroop Color-Word Test reaction time', 'timeFrame': 'Immediately after completing the task', 'description': 'Instrument: Stroop Color-Word Test Unit: Milliseconds (ms) Interpretation: Higher values = slower performance (worse)'}, {'measure': 'Emotional Flexibility: Emotional Stroop Task reaction time', 'timeFrame': 'Immediately after completing the task', 'description': 'Instrument: Emotional Stroop Task Unit: Milliseconds (ms) Interpretation: Higher values = slower performance (worse).'}, {'measure': 'Perceived Controllability (Controllable) assessed by Social Controllability Task (SCT)', 'timeFrame': 'Immediately after completing the task', 'description': 'Instrument: Social Controllability Task Description: Participants ratings on a 0-100% sliding scale. Interpretation: Higher scores indicate greater perceived control.'}], 'secondaryOutcomes': [{'measure': 'Subjective Effects of Stress as assessed by the Subjective Effects Visual Analog Scale (VAS) Battery', 'timeFrame': 'Immediately after completing the task', 'description': 'Instrument: Subjective Effects Visual Analog Scale (VAS) Battery Instrument: VAS (0-100 mm) Interpretation: Higher scores indicate greater intensity of each subjective state.'}, {'measure': 'Heart Rate', 'timeFrame': 'Immediately after completing the task', 'description': 'Unit: Beats per minute (bpm) Interpretation: Higher = increased arousal'}, {'measure': 'Systolic Blood Pressure', 'timeFrame': 'Immediately after completing the task', 'description': 'Unit: mmHg Interpretation: Higher = greater pressure.'}, {'measure': 'Diastolic Blood Pressure', 'timeFrame': 'Immediately after completing the task', 'description': 'Unit: mmHg Interpretation: Higher = greater pressure.'}, {'measure': 'Opioid Demand Breakpoint as assessed by the Hypothetical Purchase Task', 'timeFrame': 'Immediately after completing the task', 'description': 'Instrument: Hypothetical Purchase Task Range: $0-$500 Interpretation: Higher = greater demand.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['opioids', 'opioid use disorder', 'stress'], 'conditions': ['Opioid Use Disorder']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Can provide informed consent and can comply with study procedures\n2. Adults aged ≥18 years\n3. 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\\])\n4. Urine sample that tests positive for opioids\n5. Test negative for pregnancy at screening (females only)\n\nExclusion Criteria:\n\n1. Being pregnant or breastfeeding\n2. Significant mental health or physical disorder, or life circumstances, that is judged by the investigators to interfere with study participation'}, 'identificationModule': {'nctId': 'NCT06954402', 'briefTitle': 'Resilience Among Individuals With Opioid Use Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'A Novel Human Laboratory Model of Resilience Among Individuals With Opioid Use Disorder', 'orgStudyIdInfo': {'id': 'IRB00438915'}, 'secondaryIdInfos': [{'id': 'K08DA058057', 'link': 'https://reporter.nih.gov/quickSearch/K08DA058057', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stress-First Sequence', 'description': '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.', 'interventionNames': ['Behavioral: Acute Stress Intervention (MAST-based)', 'Behavioral: Non-Stress Intervention (NST-based)']}, {'type': 'EXPERIMENTAL', 'label': 'Non-Stress-First Sequence', 'description': '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.', 'interventionNames': ['Behavioral: Acute Stress Intervention (MAST-based)', 'Behavioral: Non-Stress Intervention (NST-based)']}], 'interventions': [{'name': 'Acute Stress Intervention (MAST-based)', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Non-Stress-First Sequence', 'Stress-First Sequence']}, {'name': 'Non-Stress Intervention (NST-based)', 'type': 'BEHAVIORAL', 'description': 'In this control intervention, participants complete the same battery of laboratory tasks without exposure to the acute stressor.', 'armGroupLabels': ['Non-Stress-First Sequence', 'Stress-First Sequence']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21224', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University Bayview Medical Campus', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'centralContacts': [{'name': 'Suky Martinez, PhD', 'role': 'CONTACT', 'email': 'smart209@jh.edu', 'phone': '410-550-0007'}], 'overallOfficials': [{'name': 'Suky Martinez, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}