NCT07417059

Sex Hormones Impact on Cannabis Response

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (estimated)
• Sponsor: Maastricht University · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Detailed description

Cannabis consumption is increasing globally due to legalization and therapeutic use, prompting concerns about its impact on daily functioning and long-term effects. While research has explored cannabis' risks, the heightened vulnerability of females to its adverse effects has been overlooked. Women experience stronger acute negative reactions and progress to cannabis use disorder faster than men. This gender disparity is likely due to sex hormone (SH) fluctuations related to menstrual cycles, emphasizing the need to study cannabis' differential impact on females to address gender-specific risks and inform treatment approaches. Acute influences of cannabis (300 μg THC/kg bodyweight) on subjective state and cognition will be assessed at three different stages of the menstrual cycle, and compared to a placebo condition in a double-blind, randomized, within-subject study in occasional cannabis using biological females. Primary Objective: To assess the acute subjective drug effects (good/bad drug effect, drug liking/wanting, anxiety), cognition (attention, working memory, information processing speed, verbal memory, verbal fluency, motor inhibition), and pharmacokinetics of cannabis in females across 3 different phases of the menstrual cycle, compared to a placebo condition. Secondary Objective(s): to assess the acute effects of cannabis on interoception and pain, in females across 3 different phases of the menstrual cycle, compared to a placebo condition. Tertiary Objective(s): to assess the acute effects of cannabis on metacognition and expression of inflammatory markers in females across 3 different phases of the menstrual cycle, compared to a placebo condition.

Conditions

• Cannabis

Interventions

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

Timeline

• Start date: 2025-06-01
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2026-02-18
• Last updated: 2026-02-18

Locations

1 site across 1 country: Netherlands