Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2026-02-02 @ 4:01 PM
Study NCT ID:
NCT02456532
Status:
COMPLETED
Last Update Posted:
2024-03-29
First Post:
2015-05-06
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of Chronic Hypnotic Use 2
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], 'ancestors': [{'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069582', 'term': 'Eszopiclone'}], 'ancestors': [{'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011719', 'term': 'Pyrazines'}, {'id': 'D011725', 'term': 'Pyridines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'troehrs1@hfhs.org', 'phone': '13138026681', 'title': 'Timothy Roehrs', 'organization': 'Henry Ford Health System'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Difficulty reaching proposed enrollment target: 41 of projected 120 participants completed the study- in part due to COVID. Study is to be considered preliminary'}}, 'adverseEventsModule': {'timeFrame': '6 months', 'description': 'reported weekly by questionnaire', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Intervention: Six months of nightly placebo\n\nplacebo', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Zolpidem CR', 'description': 'Intervention: Six months of zolpidem cr 12.5 mg nightly use\n\nZolpidem CR', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 0, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Eszopiclone', 'description': 'Intervention: Six months of eszopiclone 3 mg nightly use\n\nEszopiclone', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Total Number of Capsules Taken During Discontinuation From Either Active Drug vs Placebo Over a Two Week Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Intervention: Six months of nightly placebo\n\nplacebo'}, {'id': 'OG001', 'title': 'Zolpidem CR', 'description': 'Intervention: Six months of zolpidem cr 12.5 mg nightly use\n\nZolpidem CR'}, {'id': 'OG002', 'title': 'Eszopiclone', 'description': 'Intervention: Six months of eszopiclone 3 mg nightly use\n\nEszopiclone'}], 'classes': [{'categories': [{'measurements': [{'value': '0.43', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '4.5', 'groupId': 'OG001'}, {'value': '6.3', 'spread': '10.5', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '=0.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'analyses of variance comparing the three treatment gropus'}], 'paramType': 'MEAN', 'timeFrame': 'total number of capsules chosen in week 1 and week 2 of the discontinuation period', 'description': 'instruction to stop nightly hypnotic use over a two-week discontinuation period with option to choose of 1, 2, 3 capsules, if necessary', 'unitOfMeasure': 'Total number capsules chosen', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent of Time Asleep Over Time in Bed During the Two-week Discontinuation Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Intervention: Six months of nightly placebo\n\nplacebo'}, {'id': 'OG001', 'title': 'Zolpidem CR', 'description': 'Intervention: Six months of zolpidem cr 12.5 mg nightly use\n\nZolpidem CR'}, {'id': 'OG002', 'title': 'Eszopiclone', 'description': 'Intervention: Six months of eszopiclone 3 mg nightly use\n\nEszopiclone'}], 'classes': [{'categories': [{'measurements': [{'value': '81.9', 'spread': '8.1', 'groupId': 'OG000'}, {'value': '84.4', 'spread': '5.1', 'groupId': 'OG001'}, {'value': '83.0', 'spread': '4.9', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '=0.643', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'ANOVA'}], 'paramType': 'MEAN', 'timeFrame': 'mean nightly sleep efficiency during week 1 and week 2 of the discontinuation period', 'description': 'comparing the three treatment arms for nightly hypnotic efficacy using actigraphic determined sleep efficiency over the two week discontinuation period', 'unitOfMeasure': '% sleep time/bedtime', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Intervention: Six months of nightly placebo\n\nplacebo'}, {'id': 'FG001', 'title': 'Zolpidem CR', 'description': 'Intervention: Six months of zolpidem cr 12.5 mg nightly use\n\nZolpidem CR'}, {'id': 'FG002', 'title': 'Eszopiclone', 'description': 'Intervention: Six months of eszopiclone 3 mg nightly use\n\nEszopiclone'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '41', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Intervention: Six months of nightly placebo\n\nplacebo'}, {'id': 'BG001', 'title': 'Zolpidem CR', 'description': 'Intervention: Six months of zolpidem cr 12.5 mg nightly use\n\nZolpidem CR'}, {'id': 'BG002', 'title': 'Eszopiclone', 'description': 'Intervention: Six months of eszopiclone 3 mg nightly use\n\nEszopiclone'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '41', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '47.2', 'spread': '9.1', 'groupId': 'BG000'}, {'value': '42.5', 'spread': '10.8', 'groupId': 'BG001'}, {'value': '41.1', 'spread': '12.6', 'groupId': 'BG002'}, {'value': '43.5', 'spread': '11.1', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'title': 'Count of Participants', 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '41', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Baseline PSG defined sleep efficiency', 'classes': [{'categories': [{'measurements': [{'value': '75.2', 'spread': '15.9', 'groupId': 'BG000'}, {'value': '75.7', 'spread': '10.5', 'groupId': 'BG001'}, {'value': '78.7', 'spread': '13.0', 'groupId': 'BG002'}, {'value': '76.7', 'spread': '13.3', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percent sleep per 8 hrs', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Average daytime sleep latency in min', 'classes': [{'categories': [{'measurements': [{'value': '11.1', 'spread': '5.1', 'groupId': 'BG000'}, {'value': '11.9', 'spread': '6.5', 'groupId': 'BG001'}, {'value': '11.7', 'spread': '5.1', 'groupId': 'BG002'}, {'value': '11.5', 'spread': '5.4', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'minutes', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-08-03', 'size': 376236, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-08-28T12:03', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2022-02-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-27', 'studyFirstSubmitDate': '2015-05-06', 'resultsFirstSubmitDate': '2023-06-15', 'studyFirstSubmitQcDate': '2015-05-27', 'lastUpdatePostDateStruct': {'date': '2024-03-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-03-27', 'studyFirstPostDateStruct': {'date': '2015-05-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Number of Capsules Taken During Discontinuation From Either Active Drug vs Placebo Over a Two Week Period', 'timeFrame': 'total number of capsules chosen in week 1 and week 2 of the discontinuation period', 'description': 'instruction to stop nightly hypnotic use over a two-week discontinuation period with option to choose of 1, 2, 3 capsules, if necessary'}], 'secondaryOutcomes': [{'measure': 'Percent of Time Asleep Over Time in Bed During the Two-week Discontinuation Period', 'timeFrame': 'mean nightly sleep efficiency during week 1 and week 2 of the discontinuation period', 'description': 'comparing the three treatment arms for nightly hypnotic efficacy using actigraphic determined sleep efficiency over the two week discontinuation period'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Chronic Insomnia']}, 'descriptionModule': {'briefSummary': 'This proposal will assess risks for transition from therapeutic hypnotic use to abuse in people with insomnia. The investigators will study a hypothesized at-risk sub-population, insomniacs with hyperarousal, and compare two hypnotics, a drug with mood effects, eszopiclone, versus one without mood effects, zolpidem.', 'detailedDescription': 'Persons with DSM-V diagnosed insomnia disorder, aged 18-65 yrs, with no other sleep disorders, unstable medical or psychiatric diseases or drug dependency will be entered to the trial. Following a screening NPSG and MSLT, participants will be randomized to zolpidem XR 12.5 mg (n=60), eszopiclone 3 mg (n=60), or placebo (n=50) nightly for 6 months. After 6 months of nightly use, over a 2-week choice period, they were instructed to discontinue hypnotic use, but if necessary, to self-administer either 1, 2, or 3 capsules of their assigned "blinded" medication (zolpidem XR 6.25 mg, 6.25 mg, placebo; eszopiclone 2 mg, 1 mg, placebo as capsules 1, 2 and 3 respectively; or 3 placebos). Nightly sleep at home will be recorded by actigraphy for one week after the screening NPSG and MSLT and before treatment is initiated and actigraphy again during the two week discontinuation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* DSM-5 diagnosis of insomnia\n\nExclusion Criteria:\n\n* acute or unstable medical disease,\n* current or past history of psychiatric disease, alcoholism or drug abuse, and other primary sleep disorders'}, 'identificationModule': {'nctId': 'NCT02456532', 'acronym': 'CIS2', 'briefTitle': 'Safety and Efficacy of Chronic Hypnotic Use 2', 'organization': {'class': 'OTHER', 'fullName': 'Henry Ford Health System'}, 'officialTitle': 'Risks for Transition From Therapeutic Hypnotic Use to Abuse', 'orgStudyIdInfo': {'id': '#9384'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Intervention: Six months of nightly placebo', 'interventionNames': ['Drug: placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Zolpidem CR', 'description': 'Intervention: Six months of zolpidem cr 12.5 mg nightly use', 'interventionNames': ['Drug: Zolpidem CR']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Eszopiclone', 'description': 'Intervention: Six months of eszopiclone 3 mg nightly use', 'interventionNames': ['Drug: Eszopiclone']}], 'interventions': [{'name': 'placebo', 'type': 'DRUG', 'description': 'six months of nightly placebo', 'armGroupLabels': ['Placebo']}, {'name': 'Zolpidem CR', 'type': 'DRUG', 'otherNames': ['Ambian CR'], 'description': 'six months of nightly zolpidem', 'armGroupLabels': ['Zolpidem CR']}, {'name': 'Eszopiclone', 'type': 'DRUG', 'otherNames': ['Lunesta'], 'armGroupLabels': ['Eszopiclone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'HFHS Sleep Disorders Ctr', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}], 'overallOfficials': [{'name': 'Timothy A Roehrs, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Henry Ford Health System Sleep Disorders Ctr'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Henry Ford Health System', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Bioscientist', 'investigatorFullName': 'Timothy Roehrs, PhD', 'investigatorAffiliation': 'Henry Ford Health System'}}}}