Ignite Creation Date:
2025-12-24 @ 4:59 PM
Ignite Modification Date:
2025-12-27 @ 7:04 AM
Study NCT ID:
NCT00000250
Status:
COMPLETED
Last Update Posted:
2015-05-28
First Post:
1999-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cold Water Immersion Modulates Reinforcing Effects of Nitrous Oxide - 2
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009293', 'term': 'Opioid-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D000079524', 'term': 'Narcotic-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1993-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '1995-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-26', 'studyFirstSubmitDate': '1999-09-20', 'studyFirstSubmitQcDate': '1999-09-20', 'lastUpdatePostDateStruct': {'date': '2015-05-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '1999-09-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '1995-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Subject's choice of intervention", 'timeFrame': 'After sampling trials'}]}, 'conditionsModule': {'keywords': ['nitrous oxide', 'choice', 'subjective effects', 'pain', 'analgesia', 'reinforcer', 'healthy volunteer'], 'conditions': ['Opioid-Related Disorders', 'Substance-Related Disorders']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Experimentall Clinical Psycopharmacoly 1995, 3(2):148-155'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to conduct experiments to examine subjective and reinforcing effects of nitrous oxide. Mood altering and psychomotor effects will be tested on non-drug abusers and preference procedures will be used to assess reinforcing effects. To evaluate: cold water immersion modulates the reinforcing effects of nitrous oxide in healthy volunteers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '32 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Please contact site for information.'}, 'identificationModule': {'nctId': 'NCT00000250', 'briefTitle': 'Cold Water Immersion Modulates Reinforcing Effects of Nitrous Oxide - 2', 'organization': {'class': 'OTHER', 'fullName': 'University of Chicago'}, 'officialTitle': 'Cold Water Immersion Modulates Reinforcing Effects of Nitrous Oxide', 'orgStudyIdInfo': {'id': 'NIDA-08391-2'}, 'secondaryIdInfos': [{'id': 'R01DA008391', 'link': 'https://reporter.nih.gov/quickSearch/R01DA008391', 'type': 'NIH'}, {'id': 'R01-08391-2'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Lukewarm water', 'description': 'Subjects will immerse forearm in lukewarm water while inhaling 0% and 40% N2O in 2 sampling trials, then choose between intervntions for one choice trial', 'interventionNames': ['Drug: 0% N2O', 'Drug: 40% N2O']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ice cold water', 'description': 'Subjects will immerse forearm in ice cold water while inhaling 0% and 40% N2O in 2 sampling trials, then choose between intervntions for one choice trial', 'interventionNames': ['Drug: 0% N2O', 'Drug: 40% N2O']}], 'interventions': [{'name': '0% N2O', 'type': 'DRUG', 'description': 'Subjects will inhale 100% oxygen with no N2O for 25 min then immerse forearm in warm water and cold water', 'armGroupLabels': ['Ice cold water', 'Lukewarm water']}, {'name': '40% N2O', 'type': 'DRUG', 'description': 'Subjects will inhale 40% N2O then immerse forearm in warm water and cold water', 'armGroupLabels': ['Ice cold water', 'Lukewarm water']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago, Anesthesia & Critical Care', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'James Zacny, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Chicago'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Chicago', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}