Ignite Creation Date:
2025-12-24 @ 11:00 PM
Ignite Modification Date:
2025-12-29 @ 9:30 PM
Study NCT ID:
NCT00893269
Status:
COMPLETED
Last Update Posted:
2013-12-05
First Post:
2009-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Marijuana and Prescription Medications in Mood, Performance and Sleep
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002189', 'term': 'Marijuana Abuse'}], 'ancestors': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069582', 'term': 'Eszopiclone'}, {'id': 'C495910', 'term': 'ramelteon'}, {'id': 'D000077334', 'term': 'Zolpidem'}], 'ancestors': [{'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011719', 'term': 'Pyrazines'}, {'id': 'D011725', 'term': 'Pyridines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-03', 'studyFirstSubmitDate': '2009-04-30', 'studyFirstSubmitQcDate': '2009-05-04', 'lastUpdatePostDateStruct': {'date': '2013-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-05-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Marijuana Withdrawal', 'timeFrame': 'Every day during study participation'}], 'secondaryOutcomes': [{'measure': 'Objective Sleep Assessment', 'timeFrame': 'Every day during study participation'}, {'measure': 'Cognitive Performance', 'timeFrame': 'Every day during study participation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['marijuana', 'cannabis', 'dependence', 'withdrawal'], 'conditions': ['Marijuana Dependence']}, 'referencesModule': {'references': [{'pmid': '21359104', 'type': 'DERIVED', 'citation': 'Vandrey R, Umbricht A, Strain EC. Increased blood pressure after abrupt cessation of daily cannabis use. J Addict Med. 2011 Mar;5(1):16-20. doi: 10.1097/ADM.0b013e3181d2b309.'}, {'pmid': '21296508', 'type': 'DERIVED', 'citation': 'Vandrey R, Smith MT, McCann UD, Budney AJ, Curran EM. Sleep disturbance and the effects of extended-release zolpidem during cannabis withdrawal. Drug Alcohol Depend. 2011 Aug 1;117(1):38-44. doi: 10.1016/j.drugalcdep.2011.01.003. Epub 2011 Feb 5.'}]}, 'descriptionModule': {'briefSummary': 'Heavy marijuana users report experiencing trouble sleeping when they try to quit, but this has not been carefully studied. This research is being done to learn more about sleep function in heavy marijuana users, and to determine whether a medication approved for treating insomnia can help restore normal sleep function during brief periods of abstinence.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* current use of marijuana\n* able to give informed consent\n\nExclusion Criteria:\n\n* dependence on drug other than marijuana\n* current sleep disorder\n* pregnant, breast feeding, or planning to become pregnant within the next 3 months\n* currently seeking treatment for cannabis-related problems or otherwise trying to reduce use\n* use of cannabis under the guidance of a physician for a medical disorder\n* unstable or uncontrolled cardiovascular disease (e.g., hypertension, angina)\n* allergy to study medication'}, 'identificationModule': {'nctId': 'NCT00893269', 'briefTitle': 'The Effect of Marijuana and Prescription Medications in Mood, Performance and Sleep', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'The Effect of Marijuana and Prescription Medications in Mood, Performance and Sleep', 'orgStudyIdInfo': {'id': 'NA_00017909'}, 'secondaryIdInfos': [{'id': 'R21DA025794', 'link': 'https://reporter.nih.gov/quickSearch/R21DA025794', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active Medication', 'description': 'Participants receive active hypnotic medication prior to sleep', 'interventionNames': ['Drug: eszopiclone', 'Drug: ramelteon', 'Drug: zolpidem']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants receive placebo prior to sleep', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'eszopiclone', 'type': 'DRUG', 'description': 'Oral capsule at dose recommended for adults', 'armGroupLabels': ['Active Medication']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Participants receive placebo prior to sleep', 'armGroupLabels': ['Placebo']}, {'name': 'ramelteon', 'type': 'DRUG', 'description': 'ramelteon', 'armGroupLabels': ['Active Medication']}, {'name': 'zolpidem', 'type': 'DRUG', 'description': 'zolpidem', 'armGroupLabels': ['Active Medication']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21224', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Ryan Vandrey, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Food and Drug Administration (FDA)', 'class': 'FED'}, {'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Ryan Vandrey', 'investigatorAffiliation': 'Johns Hopkins University'}}}}