Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2025-12-26 @ 11:00 AM
Study NCT ID:
NCT01450306
Status:
COMPLETED
Last Update Posted:
2024-03-15
First Post:
2011-10-06
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Exposure, D-cycloserine Enhancement, and Functional Magnetic Resonance Imaging (fMRI) in Snake Phobics
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C562465', 'term': 'Phobia, Specific'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003523', 'term': 'Cycloserine'}, {'id': 'D007171', 'term': 'Implosive Therapy'}], 'ancestors': [{'id': 'D007555', 'term': 'Isoxazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D023303', 'term': 'Oxazolidinones'}, {'id': 'D010080', 'term': 'Oxazoles'}, {'id': 'D012694', 'term': 'Serine'}, {'id': 'D021542', 'term': 'Amino Acids, Neutral'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D003887', 'term': 'Desensitization, Psychologic'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'david.tolin@hhchealth.org', 'phone': '860-545-7685', 'title': 'Dr David Tolin', 'organization': 'Hartford Hospital'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'D-cycloserine Plus Exposure Therapy', 'description': 'Single session (up to 3 hr) of in vivo exposure therapy plus 50 mg oral d-cycloserine administered 1 hr prior to exposure therapy session', 'otherNumAtRisk': 10, 'otherNumAffected': 1, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo Plus Exposure Therapy', 'description': 'Single session (up to 3 hr) of in vivo exposure therapy plus oral placebo capsule administered 1 hr prior to exposure therapy session', 'otherNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'notes': 'Mild nausea, resolved without intervention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Snake Questionnaire (SNAQ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'D-cycloserine Plus Exposure Therapy', 'description': 'Single session (up to 3 hr) of in vivo exposure therapy plus 50 mg oral d-cycloserine administered 1 hr prior to exposure therapy session'}, {'id': 'OG001', 'title': 'Placebo Plus Exposure Therapy', 'description': 'Single session (up to 3 hr) of in vivo exposure therapy plus oral placebo capsule administered 1 hr prior to exposure therapy session'}], 'classes': [{'categories': [{'measurements': [{'value': '9.6', 'spread': '5.99', 'groupId': 'OG000'}, {'value': '9.7', 'spread': '6.18', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks', 'description': '30-item self-report scale of severity of snake fear and avoidance\n\nRange: 0-30; higher values indicate greater fear severity', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Clinician's Global Impression (CGI)-Severity", 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'D-cycloserine Plus Exposure Therapy', 'description': 'Single session (up to 3 hr) of in vivo exposure therapy plus 50 mg oral d-cycloserine administered 1 hr prior to exposure therapy session'}, {'id': 'OG001', 'title': 'Placebo Plus Exposure Therapy', 'description': 'Single session (up to 3 hr) of in vivo exposure therapy plus oral placebo capsule administered 1 hr prior to exposure therapy session'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'spread': '1.15', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '.68', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks', 'description': 'Clinician rating of global illness severity (at pre- and post-treatment)\n\nCGI-Severity range 1-7; 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higher scores indicate poorer improvement; classified as responder if score = 1 or 2, nonresponder if score \\> 2', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'D-cycloserine Plus Exposure Therapy', 'description': 'Single session (up to 3 hr) of in vivo exposure therapy plus 50 mg oral d-cycloserine administered 1 hr prior to exposure therapy session'}, {'id': 'FG001', 'title': 'Placebo Plus Exposure Therapy', 'description': 'Single session (up to 3 hr) of in vivo exposure therapy plus oral placebo capsule administered 1 hr prior to exposure therapy session'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'D-cycloserine Plus Exposure Therapy', 'description': 'Single session (up to 3 hr) of in vivo exposure therapy plus 50 mg oral d-cycloserine administered 1 hr prior to exposure therapy session'}, {'id': 'BG001', 'title': 'Placebo Plus Exposure Therapy', 'description': 'Single session (up to 3 hr) of in vivo exposure therapy plus oral placebo capsule administered 1 hr prior to exposure therapy session'}, {'id': 'BG002', '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'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '39', 'spread': '13.91', 'groupId': 'BG000'}, {'value': '34.6', 'spread': '12.69', 'groupId': 'BG001'}, {'value': '37', 'spread': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-13', 'studyFirstSubmitDate': '2011-10-06', 'resultsFirstSubmitDate': '2012-05-24', 'studyFirstSubmitQcDate': '2011-10-11', 'lastUpdatePostDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-03-25', 'studyFirstPostDateStruct': {'date': '2011-10-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-04-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Snake Questionnaire (SNAQ)', 'timeFrame': '2 weeks', 'description': '30-item self-report scale of severity of snake fear and avoidance\n\nRange: 0-30; higher values indicate greater fear severity'}], 'secondaryOutcomes': [{'measure': "Clinician's Global Impression (CGI)-Severity", 'timeFrame': '2 weeks', 'description': 'Clinician rating of global illness severity (at pre- and post-treatment)\n\nCGI-Severity range 1-7; higher scores indicate greater illness severity.'}, {'measure': "Clinician's Global Impression (CGI)-Improvement", 'timeFrame': '2 weeks', 'description': 'Clinician rating of global illness severity (at post-treatment)\n\nCGI-Improvement range 1-7; higher scores indicate poorer improvement; classified as responder if score = 1 or 2, nonresponder if score \\> 2'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Specific Phobia']}, 'referencesModule': {'references': [{'pmid': '23059145', 'type': 'RESULT', 'citation': 'Nave AM, Tolin DF, Stevens MC. Exposure therapy, D-cycloserine, and functional magnetic resonance imaging in patients with snake phobia: a randomized pilot study. J Clin Psychiatry. 2012 Sep;73(9):1179-86. doi: 10.4088/JCP.11m07564.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the present study is to determine whether people receiving d-cycloserine and exposure therapy show different brain reactions to symptom provocation compared to people receiving placebo and exposure therapy.', 'detailedDescription': 'D-cycloserine (DCS) is a partial N-methyl-D-aspartate (NMDA) receptor agonist that may improve or accelerate extinction learning. We will randomly assign people with snake phobia to receive DCS or placebo, and then provide all participants with exposure therapy. We will examine whether people receiving DCS and vs. placebo show different brain reactions to symptom provocation before and after exposure therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary diagnosis of specific phobia (snakes)\n\nExclusion Criteria:\n\n* History of psychosis, obsessive-compulsive disorder, or mania\n* Recent substance abuse or suicidality\n* Previous receipt of study treatments'}, 'identificationModule': {'nctId': 'NCT01450306', 'briefTitle': 'Exposure, D-cycloserine Enhancement, and Functional Magnetic Resonance Imaging (fMRI) in Snake Phobics', 'organization': {'class': 'OTHER', 'fullName': 'Hartford Hospital'}, 'officialTitle': 'Exposure, D-cycloserine Enhancement, and Functional Magnetic Resonance Imaging (fMRI) in Snake Phobics', 'orgStudyIdInfo': {'id': 'NAVE003220HU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'D-cycloserine plus exposure therapy', 'description': 'Single session (up to 3 hr) of in vivo exposure therapy plus 50 mg oral d-cycloserine administered 1 hr prior to exposure therapy session', 'interventionNames': ['Drug: D-cycloserine', 'Behavioral: Exposure therapy']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo plus exposure therapy', 'description': 'Single session (up to 3 hr) of in vivo exposure therapy plus oral placebo capsule administered 1 hr prior to exposure therapy session', 'interventionNames': ['Behavioral: Exposure therapy', 'Drug: Placebo']}], 'interventions': [{'name': 'D-cycloserine', 'type': 'DRUG', 'description': '50 mg d-cycloserine, oral, 1 dose', 'armGroupLabels': ['D-cycloserine plus exposure therapy']}, {'name': 'Exposure therapy', 'type': 'BEHAVIORAL', 'description': 'Single session graded in vivo exposure therapy, 60-180 minutes', 'armGroupLabels': ['D-cycloserine plus exposure therapy', 'Placebo plus exposure therapy']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Single capsule of oral placebo, administered once 1 hr prior to exposure therapy', 'armGroupLabels': ['Placebo plus exposure therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06106', 'city': 'Hartford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Institute of Living/Hartford Hospital', 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}], 'overallOfficials': [{'name': 'David Tolin, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hartford Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'De-identified data will be made available upon request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hartford Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}