Ignite Creation Date:
2025-12-24 @ 9:38 PM
Ignite Modification Date:
2026-02-23 @ 12:21 PM
Study NCT ID:
NCT03226132
Status:
COMPLETED
Last Update Posted:
2021-02-01
First Post:
2017-07-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving Sleep to Reduce Risk for Substance Use Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}, {'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 73}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2018-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-27', 'studyFirstSubmitDate': '2017-07-13', 'studyFirstSubmitQcDate': '2017-07-19', 'lastUpdatePostDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Insomnia Severity Index (ISI)', 'timeFrame': 'Change from Baseline to Three Months Follow-Up'}, {'measure': 'PTSD Symptoms (PTSD Checklist-5)', 'timeFrame': 'Change from Baseline to Three Months Follow-Up'}, {'measure': 'Substance Use Disorder Symptoms (Cannabis Use Disorder Identification Test; Structured Clinical Interview for Diagnostic and Statistical Manual [DSM]-5)', 'timeFrame': 'Change from Baseline to Three Months Follow-Up'}, {'measure': 'Substance Use Motives (Marijuana Motives Measure)', 'timeFrame': 'Change from Baseline to Three Months Follow-Up'}, {'measure': 'Substance Use Frequency (Timeline Followback)', 'timeFrame': 'Change from Baseline to Three Months Follow-Up'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Substance Use Disorders', 'Insomnia', 'Posttraumatic Stress Disorder']}, 'descriptionModule': {'briefSummary': 'Substance use disorders (SUDs) are a prevalent and impairing condition, particularly among trauma exposed individuals. The current proposal aims to address the critical need for targeted direct SUD prevention in this population by intervening on a novel, malleable risk factor for SUD common among trauma-exposed individuals: sleep disturbance. Sleep disturbance prospectively predicts the development of SUD and may confer risk for SUD by increasing stress reactivity, decreasing decision-making abilities, and ultimately promoting substance use to relieve negative affect, a core etiological factor in SUD. However, to our knowledge, no experimental studies have determined whether improving sleep leads to reductions in SUD risk. As such, the current study will use a randomized controlled trial design to test the effects of brief behavioral treatment for insomnia (BBTI) against a waitlist control among a sample of trauma-exposed young adults with poor sleep and risk for SUD (N = 60). We aim to determine the direct and indirect effects of condition (BBTI vs. waitlist control) on SUD symptoms, substance use-related problems, coping motives, and posttraumatic stress symptoms through improvements in sleep. Furthermore, we will test direct and indirect effects of condition on theoretically proposed mechanisms underlying the association between sleep disturbance and SUD risk (i.e., stress reactivity, cravings in response to stress).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Trauma exposure\n* Current cannabis use\n* Insomnia symptoms\n* Age 18-30\n\nExclusion Criteria:\n\n* Severe substance use disorder\n* Receiving treatment related to sleep or substance use'}, 'identificationModule': {'nctId': 'NCT03226132', 'briefTitle': 'Improving Sleep to Reduce Risk for Substance Use Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Florida State University'}, 'officialTitle': 'Biobehavioral Mechanisms Underlying Improving Sleep to Reduce Risk for Substance Use Disorder', 'orgStudyIdInfo': {'id': 'Short01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Brief Behavioral Treatment for Insomnia', 'description': 'Brief Behavioral Treatment for Insomnia', 'interventionNames': ['Behavioral: Brief Behavioral Therapy for Insomnia']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Repeated Contact', 'description': 'Repeated Contact', 'interventionNames': ['Behavioral: Repeated Contact']}], 'interventions': [{'name': 'Brief Behavioral Therapy for Insomnia', 'type': 'BEHAVIORAL', 'description': 'Brief Behavioral Therapy for Insomnia', 'armGroupLabels': ['Brief Behavioral Treatment for Insomnia']}, {'name': 'Repeated Contact', 'type': 'BEHAVIORAL', 'description': 'Repeated Contact', 'armGroupLabels': ['Repeated Contact']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32306', 'city': 'Tallahassee', 'state': 'Florida', 'country': 'United States', 'facility': 'Anxiety and Behavioral Health Clinic', 'geoPoint': {'lat': 30.43826, 'lon': -84.28073}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Florida State University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Norman Schmidt', 'investigatorAffiliation': 'Florida State University'}}}}