RecruitingNot ApplicableNCT07417059

Sex Hormones Impact on Cannabis Response

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


Sponsor

Maastricht University

Enrollment

21 participants

Start Date

Jun 1, 2025

Study Type

INTERVENTIONAL

Conditions

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: FEMALEMin Age: 18 YearsMax Age: 40 Years

Inclusion Criteria14

  • 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 Criteria9

  • 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)

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Interventions

DRUGCannabis

Bedrobinol (13.5% THC) resulting in 300 μg/kg bodyweight THC, administered via a Storz and Bickel Mighty Medic vaporiser.

DRUGKnaster 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.


Locations(1)

Maastricht University

Maastricht, Netherlands

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NCT07417059


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