How menstrual-cycle hormones change women's responses to cannabis

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

This study will see if occasional biological female cannabis users respond differently to a measured THC dose at three phases of their menstrual cycle compared with a placebo.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 21 (estimated)
• Ages: 18 Years to 40 Years
• Sex: Female
• Sponsor: Maastricht University (other)
• Locations: 1 site (Maastricht)
• Trial ID: NCT07417059 on ClinicalTrials.gov

What this trial studies

This is a double-blind, randomized, within-subject, placebo-controlled experiment in occasional cannabis-using biological females aged 18–40. Participants will attend sessions at three defined menstrual-cycle phases and receive a single acute dose of cannabis (300 µg THC/kg bodyweight) or placebo, with order randomized. Researchers will measure subjective drug effects, multiple cognitive domains, interoception, pain responses, and THC pharmacokinetics at each session. Key eligibility requirements include regular menstrual cycles, no hormonal birth control or psychotropic medications, and a BMI between 18 and 28.

Who should consider this trial

Good fit: Ideal candidates are biological females 18–40 who use cannabis occasionally (about once a month to twice a week), have regular menstrual cycles, are not on hormonal birth control or psychotropic medications, and meet health and BMI criteria.

Not a fit: People who are male, on hormonal birth control, have irregular cycles, are heavy or daily cannabis users, or have major medical or endocrine conditions are unlikely to benefit from participating.

Why it matters

Potential benefit: If successful, the findings could clarify when females are most vulnerable to acute negative effects of THC and help tailor warnings, harm-reduction advice, and timing considerations for therapeutic use.

How similar studies have performed: Prior research shows sex differences in cannabis effects and faster progression to disorder in females, but controlled within-subject studies across menstrual phases are limited, so this approach is relatively novel.

Eligibility criteria

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)

Where this trial is running

Maastricht

• Maastricht University — Maastricht, Netherlands (RECRUITING)

Conditions: Cannabis, sex hormones, cannabis, THC