Cannabis
Bedrobinol (13.5% THC) resulting in 300 μg/kg bodyweight THC, administered via a Storz and Bickel Mighty Medic vaporiser.
TetrahydrocannabinolLoading study record…
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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.
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2026-02-18
What this record can show
This locally preserved record separates the registered protocol from source-reported registry results. Neither is a treatment recommendation.
Registry facts
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. Primary 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. Secondary 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. Tertiary 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.
Linked local records
Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.
Interventions
Bedrobinol (13.5% THC) resulting in 300 μg/kg bodyweight THC, administered via a Storz and Bickel Mighty Medic vaporiser.
TetrahydrocannabinolPlacebo 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.
Eligibility
primary outcomes
Time frame: Immediately upon inhalation, up to 3.5 hours post administration
Subjective drug effects will be measured via the drug effect questionnaire
Time frame: Baseline (-0.5 hour) and at set time periods up to 3.5 hours post administration
Blood sample will be taken to assess THC concentration in blood.
Time frame: Immediately upon inhalation, up to 3.5 hours post administration
Retrospective rating of drug effects will be measured via subjective reports on the 5-dimensional altered states of consciousness rating scale
Time frame: Immediately upon inhalation, up to 3.5 hours post administration
Measured via the sensitivity to cannabis reinforcement questionnaire,
Time frame: Immediately upon inhalation, up to 3.5 hours post administration
Measured via the marijuana craving questionnaire
Time frame: Immediately upon inhalation, up to 3.5 hours post administration
Measured via the State-Trait anxiety inventory
secondary outcomes
Time frame: +1 hr 15 minutes after administration
The Heart rate discrimination task will be used to assess interoception.
Time frame: +2.5 hours after administration
The cold pressor task will be used. Pain is assessed via how many seconds participants can keep their hand in the water.
Time frame: Immediately upon inhalation, up to 3.5 hours post administration
attention will be assessed via the psychomotor vigilance test
Time frame: Immediately upon inhalation, up to 3.5 hours post administration
Will be assessed via the digit symbol substitution test
Time frame: Immediately upon inhalation, up to 3.5 hours post administration
Will be assessed via the Immediate and Delayed Verbal Memory Test
Time frame: Immediately upon inhalation, up to 3.5 hours post administration
Will be assessed via the animal fluency test
Time frame: Immediately upon inhalation, up to 3.5 hours post administration
Assessed via the stop signal task
Time frame: +2.5 hours post administration
To assess changes in pain threshold, the pressure pain threshold task will be used.
other outcomes
Time frame: Immediately upon inhalation, up to 3.5 hours post administration
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.
Time frame: At baseline (-0.5) and 3.5 hours after treatment administration
Blood samples will be collected to measure inflammatory cytokine levels
Publications
No exact PMID-linked public article is currently readable locally.