Ignite Creation Date:
2025-12-24 @ 4:02 PM
Ignite Modification Date:
2025-12-28 @ 8:59 AM
Study NCT ID:
NCT00743366
Status:
COMPLETED
Last Update Posted:
2017-08-18
First Post:
2008-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Quetiapine on Marijuana Withdrawal and Relapse
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008385', 'term': 'Marijuana Smoking'}, {'id': 'D000074609', 'term': 'Marijuana Use'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D000073847', 'term': 'Smoking, Non-Tobacco Products'}, {'id': 'D012907', 'term': 'Smoking'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C587251', 'term': 'nabiximols'}, {'id': 'D000069348', 'term': 'Quetiapine Fumarate'}, {'id': 'D012256', 'term': 'Riboflavin'}], 'ancestors': [{'id': 'D003987', 'term': 'Dibenzothiazepines'}, {'id': 'D013841', 'term': 'Thiazepines'}, {'id': 'D013846', 'term': 'Thiepins'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005415', 'term': 'Flavins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D003067', 'term': 'Coenzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D010860', 'term': 'Pigments, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'reslabsurc@gmail.com', 'phone': '646-774-6129', 'title': 'Dr. Ziva Cooper', 'organization': 'New York State Psychiatric Institute'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Quetiapine (200mg/Day), Placebo', 'description': 'Quetiapine (200mg/day): Packaged medication in size 00 opaque capsules with riboflavin filler. Study capsules (200 mg) were administered 2 times per day (1100 and 2300 hours).', 'otherNumAtRisk': 20, 'otherNumAffected': 2, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo, Quetiapine (200mg/Day)', 'description': 'Placebo medication (2x/day): Packaged riboflavin in size 00 opaque capsules to match size of active medication. Placebo capsules were administered 2 times per day (1100 and 2300 hours).', 'otherNumAtRisk': 20, 'otherNumAffected': 1, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'gastrointestinal discomfort', 'notes': 'gastrointestinal discomfort (nausea, vomiting, stomach pain, constipation).', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Measure of Relapse: Change in Puffs Chosen Between Baseline and Relapse Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Quetiapine, Marijuana', 'description': "quetiapine's effects on marijuana withdrawal and relapse\n\nMarijuana: 0,6.9% THC\n\nQuetiapine: 0, 200 mg/day"}, {'id': 'OG001', 'title': 'Placebo, Marijuana'}], 'classes': [{'categories': [{'measurements': [{'value': '2.5', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '1.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 1-3 (Baseline) and Days 6-8 (Relapse Phase)', 'description': 'This is a measure of marijuana self-administration and relapse since each initial puff costs $10 and is a burden to overcome just to smoke.\n\nOver each 3 day period, the puffs chosen by each participant is averaged for a single value.', 'unitOfMeasure': 'Puffs', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Quetiapine (200mg/Day), Placebo', 'description': 'Quetiapine (200mg/day): Packaged medication in size 00 opaque capsules with riboflavin filler. Study capsules (200 mg) were administered 2 times per day (1100 and 2300 hours).'}, {'id': 'FG001', 'title': 'Placebo, Quetiapine (200mg/Day)', 'description': 'Placebo medication (2x/day): Packaged riboflavin in size 00 opaque capsules to match size of active medication. Placebo capsules were administered 2 times per day (1100 and 2300 hours).'}], 'periods': [{'title': 'Intervention 1 (8 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'A total of 6 participants withdrew before completion of the final inpatient phase', 'groupId': 'FG000', 'numSubjects': '7'}, {'comment': 'A total of 6 participants withdrew before completion of the final inpatient phase', 'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}, {'title': 'Intervention 2 (8 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': '14 volunteers completed the study (12 males; 2 females). An additional 6 volunteers enrolled (5 males, 1 female), but did not complete.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Overall Number of Baseline Participants'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '26', 'spread': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-17', 'studyFirstSubmitDate': '2008-08-26', 'resultsFirstSubmitDate': '2016-10-20', 'studyFirstSubmitQcDate': '2008-08-26', 'lastUpdatePostDateStruct': {'date': '2017-08-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-06-12', 'studyFirstPostDateStruct': {'date': '2008-08-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-07-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measure of Relapse: Change in Puffs Chosen Between Baseline and Relapse Phase', 'timeFrame': 'Days 1-3 (Baseline) and Days 6-8 (Relapse Phase)', 'description': 'This is a measure of marijuana self-administration and relapse since each initial puff costs $10 and is a burden to overcome just to smoke.\n\nOver each 3 day period, the puffs chosen by each participant is averaged for a single value.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['quetiapine', 'smoked marijuana', 'marijuana use'], 'conditions': ['Marijuana Smoking']}, 'referencesModule': {'references': [{'pmid': '22741619', 'type': 'RESULT', 'citation': 'Cooper ZD, Foltin RW, Hart CL, Vosburg SK, Comer SD, Haney M. A human laboratory study investigating the effects of quetiapine on marijuana withdrawal and relapse in daily marijuana smokers. Addict Biol. 2013 Nov;18(6):993-1002. doi: 10.1111/j.1369-1600.2012.00461.x. Epub 2012 Jun 28.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to investigate the interaction between marijuana and quetiapine, with the goal of using this information to improve marijuana treatment outcome.', 'detailedDescription': 'The purpose of this study is to determine if quetiapine decreases marijuana relapse in a controlled lab setting. For the purposes of this model, relapse is defined as a return to marijuana use after a period of abstinence. The study will utilize an inpatient/outpatient, counter-balanced design, with each participant maintained on placebo and quetiapine (200 mg/day) for 18 days. Participants will begin taking capsules as outpatients so that the dose can be incremented prior to the inpatient phase. While inpatient, participants will have the opportunity to self-administer placebo (0.0%) or active marijuana (6.2%) 6 times per day, depending on the study day. Our laboratory model, which has distinguished the effects of a range of medications on marijuana withdrawal and relapse, will provide important information on the effect of quetiapine as a potential short-term pharmacotherapy to facilitate abstinence in the initial stages of marijuana treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Current marijuana use:average of 2 marijuana cigarettes per day at least 4 times per week for the past 4 weeks\n* Able to perform study procedures\n* 21-45 years of age\n* Women practicing an effective form of birth control (condoms, diaphragm, birth control, pill, IUD)\n* Normal body weight\n\nExclusion Criteria:\n\n* Current, repeated illicit drug use (other than marijuana)\n* Presence of significant medical illness (e.g., diabetes, cardiovascular disease, hypertension, clinically significant abnormalities)\n* History of heart disease or current conduction system disease as indicated by QRS duration \\> 0.11\n* Request for drug treatment\n* Current parole or probation\n* Pregnancy or current lactation\n* Recent history of significant violent behavior\n* Major current Axis I psychopathology (major depressive disorder, bipolar disorder, suicide risk, schizophrenia)\n* Current use of any prescription or over-the-counter medication\n* Prior allergic or otherwise serious adverse reaction to quetiapine'}, 'identificationModule': {'nctId': 'NCT00743366', 'briefTitle': 'Effect of Quetiapine on Marijuana Withdrawal and Relapse', 'organization': {'class': 'OTHER', 'fullName': 'New York State Psychiatric Institute'}, 'officialTitle': 'Effect of Quetiapine on Marijuana Withdrawal and Relapse', 'orgStudyIdInfo': {'id': '5685'}, 'secondaryIdInfos': [{'id': '5P50DA009236', 'link': 'https://reporter.nih.gov/quickSearch/5P50DA009236', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Quetiapine (200mg/day), Marijuana (6.2%, 0.0%)', 'description': 'Quetiapine (200mg/day): Packaged medication in size 00 opaque capsules with riboflavin filler. Study capsules (200 mg) were administered 2 times per day ((1100 and 2300 hours).\n\nMarijuana: Participants each received a single marijuana cigarette (provided by the National Institute on Drug Abuse) at each smoking occasion. Marijuana cigarettes were stored frozen in an airtight container and humidified at room temperature for 24 h prior to use.', 'interventionNames': ['Drug: Marijuana', 'Drug: Quetiapine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo, Marijuana (6.2%, 0.0%)', 'description': 'Marijuana: Participants each received a single marijuana cigarette (provided by the National Institute on Drug Abuse) at each smoking occasion. Marijuana cigarettes were stored frozen in an airtight container and humidified at room temperature for 24 h prior to use.', 'interventionNames': ['Drug: Marijuana', 'Drug: Placebo oral capsule']}], 'interventions': [{'name': 'Marijuana', 'type': 'DRUG', 'otherNames': ['cannabis'], 'description': '0,6.2% THC', 'armGroupLabels': ['Placebo, Marijuana (6.2%, 0.0%)', 'Quetiapine (200mg/day), Marijuana (6.2%, 0.0%)']}, {'name': 'Quetiapine', 'type': 'DRUG', 'otherNames': ['seroquel'], 'description': '200 mg/day', 'armGroupLabels': ['Quetiapine (200mg/day), Marijuana (6.2%, 0.0%)']}, {'name': 'Placebo oral capsule', 'type': 'DRUG', 'otherNames': ['Riboflavin'], 'armGroupLabels': ['Placebo, Marijuana (6.2%, 0.0%)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York State Psychiatric Institute', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Margaret Haney, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'New York State Psychiatric Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'New York State Psychiatric Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Research Foundation for Mental Hygiene, Inc.', 'class': 'OTHER'}, {'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}