Ignite Creation Date:
2025-12-25 @ 4:28 AM
Ignite Modification Date:
2026-02-28 @ 5:31 AM
Study NCT ID:
NCT01736020
Status:
UNKNOWN
Last Update Posted:
2016-10-13
First Post:
2012-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Developing Anesthesia as Post Traumatic Stress Disorder (PTSD) Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D015742', 'term': 'Propofol'}, {'id': 'D007649', 'term': 'Ketamine'}, {'id': 'D009609', 'term': 'Nitrous Oxide'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D009589', 'term': 'Nitrogen Oxides'}, {'id': 'D005740', 'term': 'Gases'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D010087', 'term': 'Oxides'}, {'id': 'D017601', 'term': 'Oxygen Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 293}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2017-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-10-12', 'studyFirstSubmitDate': '2012-11-16', 'studyFirstSubmitQcDate': '2012-11-27', 'lastUpdatePostDateStruct': {'date': '2016-10-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-11-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Tolerability', 'timeFrame': 'Baseline', 'description': 'Subjective and objective measures of subject responses to the various agents are noted.'}], 'primaryOutcomes': [{'measure': 'Number of events remembered', 'timeFrame': 'Day 4', 'description': 'The proportion of items remembered in long-term memory 4 days after viewing emotional or neutral pictures.'}], 'secondaryOutcomes': [{'measure': 'Event-related fMRI BOLD signals', 'timeFrame': 'Baseline', 'description': 'Evoked fMRI responses to emotional and neutral pictures are measured and later correlated with subsequent memory performance.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This preclinical phase 1 development study in healthy volunteers seeks to identify if low doses of commonly used non-triggering anesthetic agents might have clinical utility for modulating emotional memory processing and to understand the nature of the brain mechanisms of drug action. Optimally, a drug, dose and brain mechanism of action will be identified that will form the foundation for future use in clinical studies of patients with PTSD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adults.\n* Between the ages of 18 and 35.\n\nExclusion Criteria:\n\n* Pregnancy.\n* Left-handed.\n* Unusual facial anatomy.\n* History of esophageal reflux.\n* Respiratory problems.\n* Central nervous system disorders.\n* Cardiovascular problems.\n* Kidney disease.\n* Diabetes.\n* History of Substance abuse.\n* History of adverse anesthetic reactions.\n* Hepatitis.\n* Failure to pass MRI screening questionnaire.\n* Fear of small-enclosed spaces.\n* Mental illness.\n* Non-native English speakers.'}, 'identificationModule': {'nctId': 'NCT01736020', 'briefTitle': 'Developing Anesthesia as Post Traumatic Stress Disorder (PTSD) Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Southern California Institute for Research and Education'}, 'officialTitle': 'Developing Anesthesia as PTSD Therapy', 'orgStudyIdInfo': {'id': 'MIRB 1007, UCI 2004-3707'}, 'secondaryIdInfos': [{'id': 'R34MH087390', 'link': 'https://reporter.nih.gov/quickSearch/R34MH087390', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Drug: Dexmedetomidine', 'Drug: Propofol', 'Drug: Ketamine', 'Drug: Nitrous Oxide', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Dexmedetomidine', 'description': 'Dexmedetomidine intravenous infusion during scan.', 'interventionNames': ['Drug: Dexmedetomidine']}, {'type': 'EXPERIMENTAL', 'label': 'Propofol', 'description': 'Propofol intravenous infusion during scan.', 'interventionNames': ['Drug: Propofol']}, {'type': 'EXPERIMENTAL', 'label': 'Ketamine', 'description': 'Ketamine intravenous infusion during scan.', 'interventionNames': ['Drug: Ketamine']}, {'type': 'EXPERIMENTAL', 'label': 'Nitrous Oxide', 'description': 'Nitrous Oxide inhalation during scan.', 'interventionNames': ['Drug: Nitrous Oxide']}], 'interventions': [{'name': 'Dexmedetomidine', 'type': 'DRUG', 'description': 'A low dose of dexmedetomidine is used during scanning after dose piloting outside the scanner for memory effects and tolerability.', 'armGroupLabels': ['Dexmedetomidine', 'Placebo']}, {'name': 'Propofol', 'type': 'DRUG', 'description': 'A low dose of propofol is used during scanning after dose piloting outside the scanner for memory effects and tolerability.', 'armGroupLabels': ['Placebo', 'Propofol']}, {'name': 'Ketamine', 'type': 'DRUG', 'description': 'A low dose of ketamine is used during scanning after dose piloting outside the scanner for memory effects and tolerability.', 'armGroupLabels': ['Ketamine', 'Placebo']}, {'name': 'Nitrous Oxide', 'type': 'DRUG', 'description': 'A low dose of nitrous oxide is used during scanning after dose piloting outside the scanner for memory effects and tolerability.', 'armGroupLabels': ['Nitrous Oxide', 'Placebo']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92697', 'city': 'Irvine', 'state': 'California', 'country': 'United States', 'facility': 'University of California, Irvine', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}], 'overallOfficials': [{'name': 'Michael T Alkire, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Irvine and Long Beach VA Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Southern California Institute for Research and Education', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}, {'name': 'University of California, Irvine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Michael Alkire', 'investigatorAffiliation': 'Southern California Institute for Research and Education'}}}}