Sex Hormones Impact on Cannabis Response

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Subjective drug effects [Срок оценки: Immediately upon inhalation, up to 3.5 hours post administration]
• THC concentration in blood [Срок оценки: Baseline (-0.5 hour) and at set time periods up to 3.5 hours post administration]
• Retrospective rating of drug effects [Срок оценки: Immediately upon inhalation, up to 3.5 hours post administration]
• Sensitivity to cannabis reinforcement [Срок оценки: Immediately upon inhalation, up to 3.5 hours post administration]
• Marijuana Craving [Срок оценки: Immediately upon inhalation, up to 3.5 hours post administration]
• Anxiety [Срок оценки: Immediately upon inhalation, up to 3.5 hours post administration]

Вторичные конечные точки (8)

• Interoception [Срок оценки: +1 hr 15 minutes after administration]
• Subjective experience of pain [Срок оценки: +2.5 hours after administration]
• Attention [Срок оценки: Immediately upon inhalation, up to 3.5 hours post administration]
• Information processing speed [Срок оценки: Immediately upon inhalation, up to 3.5 hours post administration]
• Verbal Memory [Срок оценки: Immediately upon inhalation, up to 3.5 hours post administration]
• Verbal fluency [Срок оценки: Immediately upon inhalation, up to 3.5 hours post administration]
• Motor Inhibition [Срок оценки: Immediately upon inhalation, up to 3.5 hours post administration]
• Pain threshold [Срок оценки: +2.5 hours post administration]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Двойное слепое

Основная цель

Фундаментальное исследование

Центры проведения

Нидерланды · 1 центр

• Maastricht University — Maastricht

Идентификаторы

NCT: NCT07417059 · NL87464.068.24/

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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