Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 3:01 AM
Study NCT ID:
NCT07417059
Status:
RECRUITING
Last Update Posted:
2026-02-18
First Post:
2025-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sex Hormones Impact on Cannabis Response
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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': 'C587251', 'term': 'nabiximols'}, {'id': 'D013759', 'term': 'Dronabinol'}], 'ancestors': [{'id': 'D002186', 'term': 'Cannabinoids'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Random allocation of participants to the treatment order will be done using Sealed Envelope software, by one experimenter who does not come in direct contact with the participants. The study will be double blind to the subject and the testing experimenter. One experimenter will be respond for preparing the drug treatment. If a subject is withdrawn from the study, the replacement subject will be allocated to the same treatment sequence as the subject they are replacing. Following completion of all data collection the study will be fully unblinded.'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Cannabis and placebo will be administered in an AB or BA sequence, with half of the participants following sequence AB and the other half following sequence BA. This will be done across the two menstrual cycles, meaning that each participant will receive the same treatment (either THC or placebo) consistently within one menstrual cycle. This translates to a participant receiving either THC three times in a row or placebo three times in a row during one cycle. In the next cycle, they will receive the opposite treatment. There will be a washout period of 7 days between treatments.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 21}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-10', 'studyFirstSubmitDate': '2025-06-17', 'studyFirstSubmitQcDate': '2026-02-10', 'lastUpdatePostDateStruct': {'date': '2026-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Metacognition', 'timeFrame': 'Immediately upon inhalation, up to 3.5 hours post administration', 'description': 'Before and after each task, participants will be shown full text prompts explaining the task, and asking them how well they believe they will do on the task, and upon completion, how well they think they performed.'}, {'measure': 'Inflammatory cytokines', 'timeFrame': 'At baseline (-0.5) and 3.5 hours after treatment administration', 'description': 'Blood samples will be collected to measure inflammatory cytokine levels'}], 'primaryOutcomes': [{'measure': 'Subjective drug effects', 'timeFrame': 'Immediately upon inhalation, up to 3.5 hours post administration', 'description': 'Subjective drug effects will be measured via the drug effect questionnaire'}, {'measure': 'THC concentration in blood', 'timeFrame': 'Baseline (-0.5 hour) and at set time periods up to 3.5 hours post administration', 'description': 'Blood sample will be taken to assess THC concentration in blood.'}, {'measure': 'Retrospective rating of drug effects', 'timeFrame': 'Immediately upon inhalation, up to 3.5 hours post administration', 'description': 'Retrospective rating of drug effects will be measured via subjective reports on the 5-dimensional altered states of consciousness rating scale'}, {'measure': 'Sensitivity to cannabis reinforcement', 'timeFrame': 'Immediately upon inhalation, up to 3.5 hours post administration', 'description': 'Measured via the sensitivity to cannabis reinforcement questionnaire,'}, {'measure': 'Marijuana Craving', 'timeFrame': 'Immediately upon inhalation, up to 3.5 hours post administration', 'description': 'Measured via the marijuana craving questionnaire'}, {'measure': 'Anxiety', 'timeFrame': 'Immediately upon inhalation, up to 3.5 hours post administration', 'description': 'Measured via the State-Trait anxiety inventory'}], 'secondaryOutcomes': [{'measure': 'Interoception', 'timeFrame': '+1 hr 15 minutes after administration', 'description': 'The Heart rate discrimination task will be used to assess interoception.'}, {'measure': 'Subjective experience of pain', 'timeFrame': '+2.5 hours after administration', 'description': 'The cold pressor task will be used. Pain is assessed via how many seconds participants can keep their hand in the water.'}, {'measure': 'Attention', 'timeFrame': 'Immediately upon inhalation, up to 3.5 hours post administration', 'description': 'attention will be assessed via the psychomotor vigilance test'}, {'measure': 'Information processing speed', 'timeFrame': 'Immediately upon inhalation, up to 3.5 hours post administration', 'description': 'Will be assessed via the digit symbol substitution test'}, {'measure': 'Verbal Memory', 'timeFrame': 'Immediately upon inhalation, up to 3.5 hours post administration', 'description': 'Will be assessed via the Immediate and Delayed Verbal Memory Test'}, {'measure': 'Verbal fluency', 'timeFrame': 'Immediately upon inhalation, up to 3.5 hours post administration', 'description': 'Will be assessed via the animal fluency test'}, {'measure': 'Motor Inhibition', 'timeFrame': 'Immediately upon inhalation, up to 3.5 hours post administration', 'description': 'Assessed via the stop signal task'}, {'measure': 'Pain threshold', 'timeFrame': '+2.5 hours post administration', 'description': 'To assess changes in pain threshold, the pressure pain threshold task will be used.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sex hormones', 'cannabis', 'THC'], 'conditions': ['Cannabis']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to systematically determine whether the cannabis response in human females is related to SH fluctuations throughout the menstrual cycle.', 'detailedDescription': "Cannabis consumption is increasing globally due to legalization and therapeutic use, prompting concerns about its impact on daily functioning and long-term effects. While research has explored cannabis' risks, the heightened vulnerability of females to its adverse effects has been overlooked. Women experience stronger acute negative reactions and progress to cannabis use disorder faster than men. This gender disparity is likely due to sex hormone (SH) fluctuations related to menstrual cycles, emphasizing the need to study cannabis' differential impact on females to address gender-specific risks and inform treatment approaches. Acute influences of cannabis (300 μg THC/kg bodyweight) on subjective state and cognition will be assessed at three different stages of the menstrual cycle, and compared to a placebo condition in a double-blind, randomized, within-subject study in occasional cannabis using biological females.\n\nPrimary Objective: To assess the acute subjective drug effects (good/bad drug effect, drug liking/wanting, anxiety), cognition (attention, working memory, information processing speed, verbal memory, verbal fluency, motor inhibition), and pharmacokinetics of cannabis in females across 3 different phases of the menstrual cycle, compared to a placebo condition.\n\nSecondary Objective(s): to assess the acute effects of cannabis on interoception and pain, in females across 3 different phases of the menstrual cycle, compared to a placebo condition.\n\nTertiary Objective(s): to assess the acute effects of cannabis on metacognition and expression of inflammatory markers in females across 3 different phases of the menstrual cycle, compared to a placebo condition."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Biological female\n* Used cannabis between 1 time a month and 2 times a week during the previous year\n* Age between 18 and 40 years\n* Free from psychotropic medication\n* Free from hormonal birth control\n* A regular menstrual cycle (last 3 cycles a duration between 21 and 35 days).\n* Good physical health as determined by medical examination and laboratory analysis\n* Absence of any major medical, endocrine and neurological condition as determined by medical examination and laboratory analysis\n* Normal weight, body mass index (weight/height2) between 18 and 28 kg/m2\n* Written Informed Consent\n* Good knowledge and understanding of the English language\n* Participants must be willing to refrain from taking illicit psychoactive substances during the study.\n* Participants must be willing to drink only alcohol-free liquids and no coffee, black or green tea, or energy drinks after midnight of the evening before the study session, as well as during the study day.\n* Participants must be willing not to drive a traffic vehicle or to operate machines within 24 h after substance administration.\n\nExclusion Criteria:\n\n* History of drug addiction (determined by the medical questionnaire, drug questionnaire and medical examination)\n* Pregnancy or lactation or pregnancy planned during study participation\n* Hypertension (diastolic \\> 90 mmHg; systolic \\> 140 mmHg)\n* Current or history of psychiatric disorder (determined by the medical questionnaire and medical examination)\n* Current presence or history of psychosis in first-degree relatives\n* Any chronic or acute medical condition\n* History of cardiac dysfunctions (arrhythmia, ischemic heart disease,…)\n* Tobacco smoking (\\>20 per day)\n* Excessive drinking (\\>20 alcoholic consumptions per week)'}, 'identificationModule': {'nctId': 'NCT07417059', 'briefTitle': 'Sex Hormones Impact on Cannabis Response', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht University'}, 'officialTitle': 'The Influence of Female Sex Hormones on the Subjective and Cognitive Response to Cannabis', 'orgStudyIdInfo': {'id': 'NL87464.068.24/'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cannabis', 'description': 'All participants will receive cannabis on 3 separate occasions during different phases of the menstrual cycle.', 'interventionNames': ['Drug: Cannabis']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Knaster hemp', 'description': 'All participants will receive knaster hemp on 3 separate occasions during different phases of the menstrual cycle.', 'interventionNames': ['Drug: Knaster Hemp']}], 'interventions': [{'name': 'Cannabis', 'type': 'DRUG', 'otherNames': ['Tetrahydrocannabinol'], 'description': 'Bedrobinol (13.5% THC) resulting in 300 μg/kg bodyweight THC, administered via a Storz and Bickel Mighty Medic vaporiser.', 'armGroupLabels': ['Cannabis']}, {'name': 'Knaster Hemp', 'type': 'DRUG', 'description': 'Placebo will consist of knaster hemp, a freely sold aromatic herbal mixture for smoking. Participants will receive a dose of 50 mg of knaster hemp, administered via a Storz and Bickel Mighty Medic vaporiser.', 'armGroupLabels': ['Knaster hemp']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Maastricht', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Natasha L Mason, PhD', 'role': 'CONTACT', 'email': 'natasha.mason@maastrichtuniversity.nl', 'phone': '+31 (0)43 388 1382'}], 'facility': 'Maastricht University', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Natasha Mason', 'investigatorAffiliation': 'Maastricht University'}}}}