Ignite Creation Date:
2025-12-25 @ 12:57 AM
Ignite Modification Date:
2026-02-25 @ 5:33 PM
Study NCT ID:
NCT03826693
Status:
RECRUITING
Last Update Posted:
2025-08-27
First Post:
2019-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Nitrous Oxide in OCD: Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009771', 'term': 'Obsessive-Compulsive Disorder'}], 'ancestors': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009609', 'term': 'Nitrous Oxide'}, {'id': 'D009584', 'term': 'Nitrogen'}], 'ancestors': [{'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'}, {'id': 'D004602', 'term': 'Elements'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'placebo-controlled 2:1 randomized clinical trial.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-04-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-20', 'studyFirstSubmitDate': '2019-01-30', 'studyFirstSubmitQcDate': '2019-01-30', 'lastUpdatePostDateStruct': {'date': '2025-08-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement in the severity of OCD symptoms as measured by the Yale-Brown Obsessive Compulsive Scale (YBOCS)', 'timeFrame': '1 week', 'description': 'Improvement in OCD severity is measured by the YBOCS (Yale Brown Obsessive-Compulsive Scale), a gold standard measure of obsessions and compulsions. For the YBOCS the minimum units are 0 and Maximum units on the total scale are 40. The higher the number on the YBOCS, the more severe the symptoms. Response is defined as at least a 35% reduction on the YBOCS.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['OCD', 'nitrous oxide'], 'conditions': ['Obsessive-Compulsive Disorder']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://med.stanford.edu/profiles/peter-van-roessel', 'label': 'Stanford Medicine Faculty Page'}, {'url': 'https://rodriguezlab.stanford.edu', 'label': 'Rodriguez Lab Website'}]}, 'descriptionModule': {'briefSummary': 'This study investigates whether the commonly used and well-tolerated inhaled anesthetic nitrous oxide can rapidly improve symptoms of OCD.', 'detailedDescription': 'Obsessive-compulsive disorder (OCD) is a chronic and disabling disorder characterized by recurrent intrusive thoughts and associated compulsive behaviors that is estimated to affect more than 3 million individuals in the US each year.\n\nThis study seeks to explore whether a single inhalation of nitrous oxide gas may bring about rapid symptom relief in OCD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-65\n* Primary diagnosis of OCD\n* Sufficient severity of OCD symptoms\n* Ability to tolerate a treatment-free period\n* Capacity to provide informed consent\n\nExclusion Criteria:\n\n* Psychiatric or medical conditions that make participation unsafe\n* Pregnant or nursing females\n* Concurrent use of any medications that might increase the risk of participation (e.g. drug interactions)'}, 'identificationModule': {'nctId': 'NCT03826693', 'briefTitle': 'Efficacy of Nitrous Oxide in OCD: Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Efficacy of Nitrous Oxide in OCD: Pilot Study', 'orgStudyIdInfo': {'id': '48077'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental: Nitrous Oxide', 'description': 'OCD participants in this arm will receive 50%oxygen/50% nitrous oxide admixture for 60 minutes.', 'interventionNames': ['Drug: Nitrous Oxide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control: Nitrogen', 'description': 'OCD participants in this arm will receive 50%oxygen/50% nitrogen admixture for 60 minutes.', 'interventionNames': ['Drug: Nitrogen']}], 'interventions': [{'name': 'Nitrous Oxide', 'type': 'DRUG', 'description': 'OCD participants in this arm will receive 50%oxygen/50% nitrous oxide admixture for 60 minutes.', 'armGroupLabels': ['Experimental: Nitrous Oxide']}, {'name': 'Nitrogen', 'type': 'DRUG', 'description': 'OCD participants in this arm will receive 50%oxygen/50% nitrogen admixture for 60 minutes.', 'armGroupLabels': ['Control: Nitrogen']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94304', 'city': 'Stanford', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Pavithra Makunda, MS', 'role': 'CONTACT', 'email': 'ocdresearch@stanford.edu', 'phone': '650-723-4095'}, {'name': 'Sindu Menon, MBBS', 'role': 'CONTACT', 'email': 'ocdresearch@stanford.edu', 'phone': '650-723-4095'}, {'name': 'Peter van Roessel, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Stanford University', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'centralContacts': [{'name': 'Pavithra Mukunda, MS', 'role': 'CONTACT', 'email': 'ocdresearch@stanford.edu', 'phone': '650-723-4095'}, {'name': 'Sindu Menon, MBBS', 'role': 'CONTACT', 'email': 'ocdresearch@stanford.edu', 'phone': '650-723-4095'}], 'overallOfficials': [{'name': 'Peter J van Roessel, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford Univeristy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Brain & Behavior Research Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Associate Professor, Department of Psychiatry and Behavioral Sciences', 'investigatorFullName': 'Peter J van Roessel, MD PhD', 'investigatorAffiliation': 'Stanford University'}}}}