Cannabis: Bedrobinol (13.5% THC) resulting in 300 μg/kg bodyweight THC, administered via a Storz and Bickel Mighty Medic vaporiser.
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.
Study 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.
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
40 Years
Healthy volunteers
Accepted
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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)
Primary outcome measure(s)
Subjective drug effects — 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 — 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 — 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 — Immediately upon inhalation, up to 3.5 hours post administration Measured via the sensitivity to cannabis reinforcement questionnaire,
Marijuana Craving — Immediately upon inhalation, up to 3.5 hours post administration Measured via the marijuana craving questionnaire
Anxiety — Immediately upon inhalation, up to 3.5 hours post administration Measured via the State-Trait anxiety inventory
Trial sites (1)
Facility
City
Region
Status
Maastricht University
Maastricht
Netherlands
Recruiting
More Maastricht University trials in the Netherlands
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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