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Clinical Trial NCT07417059 for Cannabis is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Sex Hormones Impact on Cannabis Response 21

Recruiting
Clinical Trial NCT07417059 is an interventional study for Cannabis that is recruiting. It started on 1 June 2025 with plans to enroll 21 participants. Led by Maastricht University, it is expected to complete by 31 December 2026. The latest data from ClinicalTrials.gov was last updated on 18 February 2026.
Brief 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.
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 disparit...Show More
Official Title

The Influence of Female Sex Hormones on the Subjective and Cognitive Response to Cannabis

Conditions
Cannabis
Other Study IDs
  • NL87464.068.24/
NCT ID Number
NCT07417059
Start Date (Actual)
2025-06-01
Last Update Posted
2026-02-18
Completion Date (Estimated)
2026-12-31
Enrollment (Estimated)
21
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
sex hormones
cannabis
THC
Primary Purpose
Basic Science
Design Allocation
Randomized
Interventional Model
Crossover Assignment
Masking
Double
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalCannabis
All participants will receive cannabis on 3 separate occasions during different phases of the menstrual cycle.
Cannabis
Bedrobinol (13.5% THC) resulting in 300 μg/kg bodyweight THC, administered via a Storz and Bickel Mighty Medic vaporiser.
Placebo ComparatorKnaster hemp
All participants will receive knaster hemp on 3 separate occasions during different phases of the menstrual cycle.
Knaster Hemp
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.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Subjective drug effects
Subjective drug effects will be measured via the drug effect questionnaire
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.
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
Immediately upon inhalation, up to 3.5 hours post administration
Sensitivity to cannabis reinforcement
Measured via the sensitivity to cannabis reinforcement questionnaire,
Immediately upon inhalation, up to 3.5 hours post administration
Marijuana Craving
Measured via the marijuana craving questionnaire
Immediately upon inhalation, up to 3.5 hours post administration
Anxiety
Measured via the State-Trait anxiety inventory
Immediately upon inhalation, up to 3.5 hours post administration
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Interoception
The Heart rate discrimination task will be used to assess interoception.
+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.
+2.5 hours after administration
Attention
attention will be assessed via the psychomotor vigilance test
Immediately upon inhalation, up to 3.5 hours post administration
Information processing speed
Will be assessed via the digit symbol substitution test
Immediately upon inhalation, up to 3.5 hours post administration
Verbal Memory
Will be assessed via the Immediate and Delayed Verbal Memory Test
Immediately upon inhalation, up to 3.5 hours post administration
Verbal fluency
Will be assessed via the animal fluency test
Immediately upon inhalation, up to 3.5 hours post administration
Motor Inhibition
Assessed via the stop signal task
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.
+2.5 hours post administration
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult
Minimum Age
18 Years
Eligible Sexes
Female
Accepts Healthy Volunteers
Yes
  • 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).
  • 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.

  • 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
  • History of cardiac dysfunctions (arrhythmia, ischemic heart disease,…)
  • Tobacco smoking (>20 per day)
  • Excessive drinking (>20 alcoholic consumptions per week)
Maastricht University logoMaastricht University
Study Responsible Party
Natasha Mason, Principal Investigator, Assistant Professor, Maastricht University
No contact data.
1 Study Locations in 1 Countries
Maastricht University, Maastricht, Netherlands
Natasha L Mason, PhD, Contact, +31 (0)43 388 1382, [email protected]
Recruiting