drug effects Not applicable
Conditions
Interventions
Participants will receive three doses of cannabis (300 µg THC/kg bodyweight),
and three doses of placebo on separate testing days, during specific phases of
their menstrual cycle.
Sponsors
Universiteit Maastricht
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: To be eligible to participate in this study, a participant must meet all the following 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
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: * 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameter is the drug-induced change in subjective state, cognition, and pharmacokinetics across the menstrual cycle, when comparing cannabis to placebo. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary parameters include changes in interoception and pain. Tertiary parameters include changes in inflammatory cytokine expression. | — |
Countries
Netherlands
Outcome results
None listed