Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2026-03-02 @ 4:26 AM
Study NCT ID:
NCT02335060
Status:
TERMINATED
Last Update Posted:
2022-01-31
First Post:
2015-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
N-acetylcysteine Effects on Tetrahydrocannabinol
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002189', 'term': 'Marijuana Abuse'}, {'id': 'D011618', 'term': 'Psychotic Disorders'}], 'ancestors': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013759', 'term': 'Dronabinol'}, {'id': 'D000111', 'term': 'Acetylcysteine'}], 'ancestors': [{'id': 'D002186', 'term': 'Cannabinoids'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003545', 'term': 'Cysteine'}, {'id': 'D000603', 'term': 'Amino Acids, Sulfur'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'whyStopped': 'Feasibility pilot was completed', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-05-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2014-09-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-19', 'studyFirstSubmitDate': '2015-01-05', 'studyFirstSubmitQcDate': '2015-01-06', 'lastUpdatePostDateStruct': {'date': '2022-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-01-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Positive and Negative Symptom Scale for Schizophrenia (PANSS)', 'timeFrame': '-30 minutes from administration of THC', 'description': 'Positive, negative, and general symptoms will be assessed using the positive, negative, and general symptom subscales of the PANSS'}, {'measure': 'Positive and Negative Symptom Scale for Schizophrenia (PANSS)', 'timeFrame': '+15 minutes from administration of THC', 'description': 'Positive, negative, and general symptoms will be assessed using the positive, negative, and general symptom subscales of the PANSS'}, {'measure': 'Positive and Negative Symptom Scale for Schizophrenia (PANSS)', 'timeFrame': '+90 minutes from administration of THC', 'description': 'Positive, negative, and general symptoms will be assessed using the positive, negative, and general symptom subscales of the PANSS'}, {'measure': 'Positive and Negative Symptom Scale for Schizophrenia (PANSS)', 'timeFrame': '+240 minutes from administration of THC', 'description': 'Positive, negative, and general symptoms will be assessed using the positive, negative, and general symptom subscales of the PANSS'}, {'measure': 'Positive and Negative Symptom Scale for Schizophrenia (PANSS)', 'timeFrame': '-60 minutes from administration of THC', 'description': 'Positive, negative, and general symptoms will be assessed using the positive, negative, and general symptom subscales of the PANSS'}], 'secondaryOutcomes': [{'measure': 'Clinician Administered Dissociative Symptoms Scale (CADSS)', 'timeFrame': '-60min, -30min, +15min, +90min, +240min from administration of THC', 'description': 'Perceptual alterations will be measured using the CADSS. This is a scale consisting of 19 self-reported items and 8 clinician-rated items. The scale captures alterations in environmental/time/body perception, feelings of unreality, and memory impairment.'}, {'measure': 'Visual Analog Scale (VAS)', 'timeFrame': '-60min, -30min, +15min, +90min, +240min from administration of THC', 'description': 'Feeling states associated with cannabis intoxication will be measured using a self-reported visual analog scale of feeling states associated with cannabis effects (ex: "high," "calm," "anxious"). Subjects will be asked to score the perceived intensity of these feeling states at that moment on a 11mm line. These data will be captured to validate that the experiment is relevant to cannabis effects.'}, {'measure': 'Cognitive Test Battery', 'timeFrame': '+20min from administration of THC', 'description': 'Several computer tasks will be administered in order to evaluate the effects of cannabis on recognition memory, working memory, and attention. The battery consists of four computer tasks that lasts no longer than 20 minutes in total.'}, {'measure': 'Hopkins Verbal Learning Test (HVLT)', 'timeFrame': '+20min from administration of THC', 'description': 'The HVLT is a 12 word list that is semantically organized. The task consists of 5 trials and a different version of the HVLT will be administered on each test day.'}, {'measure': 'Psychotomimetic States Inventory (PSI)', 'timeFrame': '-60min, -30min, +240min from administration of THC', 'description': 'The PSI is a measure of drug induced psychotomimetic states. This self-reported scale consists of 28 items rated 0 (not at all) to 3 (extremely) and will facilitate the characterization of a wide range of dissociative/hallucinatory phenomena as well as cognitive disorganization associated with the administration of THC.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['cannabis', 'Marijuana', 'THC', 'N-acetylcysteine', 'Psychotic Disorders'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The overall purpose of this study is to examine the effect of N-acetylcysteine (NAC) on the acute effects of Delta-9-tetrahydrocannabinol (THC). This will be tested by pretreating healthy individuals with NAC and then assessing their responses to THC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Exposed to Cannabis at least once in lifetime\n\nExclusion Criteria:\n\n* Cannabis Naive\n* Individuals with a documented allergy to N-acetylcysteine'}, 'identificationModule': {'nctId': 'NCT02335060', 'briefTitle': 'N-acetylcysteine Effects on Tetrahydrocannabinol', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'Effect of N-acetylcysteine on the Acute Cognitive Effects of Delta-9-Tetrahydrocannabinol', 'orgStudyIdInfo': {'id': '1402013406'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active N-acetylcysteine and Active Delta-9-THC', 'interventionNames': ['Drug: Delta-9-THC', 'Drug: N-acetylcysteine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo and Active Delta-9-THC', 'interventionNames': ['Drug: Delta-9-THC', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Active N-acetylcysteine and Placebo', 'interventionNames': ['Drug: N-acetylcysteine', 'Drug: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo and Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Delta-9-THC', 'type': 'DRUG', 'description': 'Active Delta-9-THC (0.036mg/Kg) given intravenously.', 'armGroupLabels': ['Active N-acetylcysteine and Active Delta-9-THC', 'Placebo and Active Delta-9-THC']}, {'name': 'N-acetylcysteine', 'type': 'DRUG', 'description': 'A pill given orally.', 'armGroupLabels': ['Active N-acetylcysteine and Active Delta-9-THC', 'Active N-acetylcysteine and Placebo']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo (about a quarter spoon of alcohol with no THC) given intravenously.', 'armGroupLabels': ['Active N-acetylcysteine and Placebo', 'Placebo and Placebo']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo "sugar" pill given orally with no N-acetylcysteine.', 'armGroupLabels': ['Placebo and Active Delta-9-THC', 'Placebo and Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06516', 'city': 'West Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'VA Connecticut Healthcare System', 'geoPoint': {'lat': 41.27065, 'lon': -72.94705}}], 'overallOfficials': [{'name': 'Mohini Ranganathan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University Medical School'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Mohini Ranganathan', 'investigatorAffiliation': 'Yale University'}}}}