CannabisNCT07417059
Sex Hormones Impact on Cannabis Response
A study testing Cannabis and Knaster Hemp in people with Cannabis, run by Maastricht University at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cannabis
- What is being tested?
- Cannabis and Knaster Hemp
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jun 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Biological female
- Used cannabis between 1 time a month and 2 times a week during the previous year
- Age between 18 and 40 years
- Free from psychotropic medication
- Free from hormonal birth control
- A regular menstrual cycle (last 3 cycles a duration between 21 and 35 days).
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- Good physical health as determined by medical examination and laboratory analysis
- Absence of any major medical, endocrine and neurological condition as determined by medical examination and laboratory analysis
- Normal weight, body mass index (weight/height2) between 18 and 28 kg/m2
- Written Informed Consent
- Good knowledge and understanding of the English language
- Participants must be willing to refrain from taking illicit psychoactive substances during the study.
- 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.
- Participants must be willing not to drive a traffic vehicle or to operate machines within 24 h after substance administration.
Who cannot join
- History of drug addiction (determined by the medical questionnaire, drug questionnaire and medical examination)
- Pregnancy or lactation or pregnancy planned during study participation
- Hypertension (diastolic > 90 mmHg; systolic > 140 mmHg)
- Current or history of psychiatric disorder (determined by the medical questionnaire and medical examination)
- Current presence or history of psychosis in first-degree relatives
- Any chronic or acute medical condition
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- History of cardiac dysfunctions (arrhythmia, ischemic heart disease,…)
- Tobacco smoking (>20 per day)
- Excessive drinking (>20 alcoholic consumptions per week)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Maastricht University
Maastricht
Natasha L Mason, PhD, +31 (0)43 388 1382, natasha.mason@maastrichtuniversity.nl
About this study
Official title: The Influence of Female Sex Hormones on the Subjective and Cognitive Response to Cannabis
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.
Read the detailed description
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.
- Conditions
- Cannabis
- Being tested
- Cannabis, Knaster Hemp
- Keywords
- sex hormones, cannabis, THC
- Medical subject headings
- Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CannabisDrug
Also called Tetrahydrocannabinol
Bedrobinol (13.5% THC) resulting in 300 μg/kg bodyweight THC, administered via a Storz and Bickel Mighty Medic vaporiser.
Knaster HempDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Cannabis | Experimental | All participants will receive cannabis on 3 separate occasions during different phases of the menstrual cycle. Receives: Drug: Cannabis |
| Knaster hemp | Placebo comparator | All participants will receive knaster hemp on 3 separate occasions during different phases of the menstrual cycle. Receives: Drug: Knaster Hemp |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective drug effects
Subjective drug effects will be measured via the drug effect questionnaire
Measured: 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.
Measured: 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
Measured: Immediately upon inhalation, up to 3.5 hours post administration
Sensitivity to cannabis reinforcement
Measured via the sensitivity to cannabis reinforcement questionnaire,
Measured: Immediately upon inhalation, up to 3.5 hours post administration
Marijuana Craving
Measured via the marijuana craving questionnaire
Measured: Immediately upon inhalation, up to 3.5 hours post administration
Anxiety
Measured via the State-Trait anxiety inventory
Measured: Immediately upon inhalation, up to 3.5 hours post administration
Secondary outcomes (8)
Interoception
The Heart rate discrimination task will be used to assess interoception.
Measured: +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.
Measured: +2.5 hours after administration
Attention
attention will be assessed via the psychomotor vigilance test
Measured: Immediately upon inhalation, up to 3.5 hours post administration
Information processing speed
Will be assessed via the digit symbol substitution test
Measured: Immediately upon inhalation, up to 3.5 hours post administration
Verbal Memory
Will be assessed via the Immediate and Delayed Verbal Memory Test
Measured: Immediately upon inhalation, up to 3.5 hours post administration
Verbal fluency
Will be assessed via the animal fluency test
Measured: Immediately upon inhalation, up to 3.5 hours post administration
Motor Inhibition
Assessed via the stop signal task
Measured: 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.
Measured: +2.5 hours post administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start1 Jun 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CannabisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Natasha Mason, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07417059
- Sponsor's protocol ID
- NL87464.068.24/
- Status last verified
- Feb 2026
- First submitted
- 17 Jun 2025
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Female Sex Hormones on the Subjective and Cognitive Response to Cannabis
- ClinicalTrials.gov ID
- NCT07417059
- Acronym / sponsor ID
- NL87464.068.24/
- Conditions
- Cannabis
- Keywords
- sex hormones, cannabis, THC
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Maastricht UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 18 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Cannabis | Experimental | Drug: CannabisAll participants will receive cannabis on 3 separate occasions during different phases of the menstrual cycle. |
| Knaster hemp | Placebo comparator | Drug: Knaster HempAll participants will receive knaster hemp on 3 separate occasions during different phases of the menstrual cycle. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Biological female
- Used cannabis between 1 time a month and 2 times a week during the previous year
- Age between 18 and 40 years
- Free from psychotropic medication
- Free from hormonal birth control
Key exclusion criteria (9 listed)
- History of drug addiction (determined by the medical questionnaire, drug questionnaire and medical examination)
- Pregnancy or lactation or pregnancy planned during study participation
- Hypertension (diastolic > 90 mmHg; systolic > 140 mmHg)
- Current or history of psychiatric disorder (determined by the medical questionnaire and medical examination)
- Current presence or history of psychosis in first-degree relatives
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CannabisAlso: TetrahydrocannabinolBedrobinol (13.5% THC) resulting in 300 μg/kg bodyweight THC, administered via a Storz and Bickel Mighty Medic vaporiser. | Drug | Cannabis |
| Knaster HempPlacebo 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. | Drug | Knaster hemp |
Primary outcome
Subjective drug effects
Time frame: Immediately upon inhalation, up to 3.5 hours post administration
Subjective drug effects will be measured via the drug effect questionnaire
THC concentration in blood
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.
Retrospective rating of drug effects
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
Sensitivity to cannabis reinforcement
Time frame: Immediately upon inhalation, up to 3.5 hours post administration
Measured via the sensitivity to cannabis reinforcement questionnaire,
Marijuana Craving
Time frame: Immediately upon inhalation, up to 3.5 hours post administration
Measured via the marijuana craving questionnaire
Anxiety
Time frame: Immediately upon inhalation, up to 3.5 hours post administration
Measured via the State-Trait anxiety inventory
8 secondary outcomes
Interoception
Time frame: +1 hr 15 minutes after administration
Subjective experience of pain
Time frame: +2.5 hours after administration
Attention
Time frame: Immediately upon inhalation, up to 3.5 hours post administration
Information processing speed
Time frame: Immediately upon inhalation, up to 3.5 hours post administration
Verbal Memory
Time frame: Immediately upon inhalation, up to 3.5 hours post administration
Verbal fluency
Time frame: Immediately upon inhalation, up to 3.5 hours post administration
Motor Inhibition
Time frame: Immediately upon inhalation, up to 3.5 hours post administration
Pain threshold
Time frame: +2.5 hours post administration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cannabis and Knaster Hemp in people with Cannabis, run by Maastricht University at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective drug effects (time frame: Immediately upon inhalation, up to 3.5 hours post administration). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.