An interventional study of Cannabis and Knaster Hemp in Cannabis, sponsored by Maastricht University. Recruiting at 1 site in Netherlands. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-18.
Sponsored by Maastricht University · Not applicable, Interventional, and Basic science
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.
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.
Maastricht University is the lead sponsor of 97 studies on the registry; 20 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All participants will receive cannabis on 3 separate occasions during different phases of the menstrual cycle.
Drug: Cannabis
All participants will receive knaster hemp on 3 separate occasions during different phases of the menstrual cycle.
Drug: Knaster Hemp
Bedrobinol (13.5% THC) resulting in 300 μg/kg bodyweight THC, administered via a Storz and Bickel Mighty Medic vaporiser.
Also known as: Tetrahydrocannabinol
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.
Subjective drug effects
Subjective drug effects will be measured via the drug effect questionnaire
Time frame: Immediately upon inhalation, up to 3.5 hours post administration
THC concentration in blood
Blood sample will be taken to assess THC concentration in blood.
Time frame: Baseline (-0.5 hour) and at set time periods up to 3.5 hours post administration
Retrospective rating of drug effects
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
Sensitivity to cannabis reinforcement
Measured via the sensitivity to cannabis reinforcement questionnaire,
Time frame: Immediately upon inhalation, up to 3.5 hours post administration
Marijuana Craving
Measured via the marijuana craving questionnaire
Time frame: Immediately upon inhalation, up to 3.5 hours post administration
Anxiety
Measured via the State-Trait anxiety inventory
Time frame: Immediately upon inhalation, up to 3.5 hours post administration
Interoception
The Heart rate discrimination task will be used to assess interoception.
Time frame: +1 hr 15 minutes after administration
Subjective experience of pain
The cold pressor task will be used. Pain is assessed via how many seconds participants can keep their hand in the water.
Time frame: +2.5 hours after administration
Attention
attention will be assessed via the psychomotor vigilance test
Time frame: Immediately upon inhalation, up to 3.5 hours post administration
Information processing speed
Will be assessed via the digit symbol substitution test
Time frame: Immediately upon inhalation, up to 3.5 hours post administration
Verbal Memory
Will be assessed via the Immediate and Delayed Verbal Memory Test
Time frame: Immediately upon inhalation, up to 3.5 hours post administration
Verbal fluency
Will be assessed via the animal fluency test
Time frame: Immediately upon inhalation, up to 3.5 hours post administration
Motor Inhibition
Assessed via the stop signal task
Time frame: Immediately upon inhalation, up to 3.5 hours post administration
Pain threshold
To assess changes in pain threshold, the pressure pain threshold task will be used.
Time frame: +2.5 hours post administration
Metacognition
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: Immediately upon inhalation, up to 3.5 hours post administration
Inflammatory cytokines
Blood samples will be collected to measure inflammatory cytokine levels
Time frame: At baseline (-0.5) and 3.5 hours after treatment administration
Plan to share: No
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Studies of the drug tested here: Cannabis sativa subsp. indica TOP
Maastricht University