Sex Hormones Impact on Cannabis Response

NCT07417059 | Recruiting

• 1 other identifier: NL87464.068.24/
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Cannabis

Keywords

sex hormones; cannabis; THC

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (8)

• Interoception

  +1 hr 15 minutes after administration

• Subjective experience of pain

  +2.5 hours after administration

• Attention

  Immediately upon inhalation, up to 3.5 hours post administration

• Information processing speed

  Immediately upon inhalation, up to 3.5 hours post administration

• Verbal Memory

  Immediately upon inhalation, up to 3.5 hours post administration

Other Outcomes (2)

• Metacognition

  Immediately upon inhalation, up to 3.5 hours post administration

• Inflammatory cytokines

  At baseline (-0.5) and 3.5 hours after treatment administration

Study Arms (2)

Cannabis

EXPERIMENTAL

All participants will receive cannabis on 3 separate occasions during different phases of the menstrual cycle.

Drug: Cannabis

Knaster hemp

PLACEBO COMPARATOR

All participants will receive knaster hemp on 3 separate occasions during different phases of the menstrual cycle.

Drug: Knaster Hemp

Interventions

Cannabis DRUG

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

Also known as: Tetrahydrocannabinol

Cannabis

Knaster Hemp DRUG

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.

Knaster hemp

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Maastricht University: lead

Study Sites (1)

Maastricht University

Maastricht, Netherlands

RECRUITING

MeSH Terms

Conditions

Marijuana Abuse

Interventions

nabiximols; Dronabinol

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Random allocation of participants to the treatment order will be done using Sealed Envelope software, by one experimenter who does not come in direct contact with the participants. The study will be double blind to the subject and the testing experimenter. One experimenter will be respond for preparing the drug treatment. If a subject is withdrawn from the study, the replacement subject will be allocated to the same treatment sequence as the subject they are replacing. Following completion of all data collection the study will be fully unblinded.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Cannabis and placebo will be administered in an AB or BA sequence, with half of the participants following sequence AB and the other half following sequence BA. This will be done across the two menstrual cycles, meaning that each participant will receive the same treatment (either THC or placebo) consistently within one menstrual cycle. This translates to a participant receiving either THC three times in a row or placebo three times in a row during one cycle. In the next cycle, they will receive the opposite treatment. There will be a washout period of 7 days between treatments.

Study Record Dates

• First Submitted: June 17, 2025
• First Posted: February 18, 2026
• Study Start: June 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)