Sex Hormones Impact on Cannabis Response
ConditionCannabis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorMaastricht University
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Crossover
Treatments tested in this trial
Cannabis
DrugBedrobinol (13.5% THC) resulting in 300 μg/kg bodyweight THC, administered via a Storz and Bickel Mighty Medic vaporiser.
Knaster Hemp
DrugPlacebo 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.
Treatment groups
21 Participants
are divided into 2 treatment groupsGroup A: CannabisExperimental treatment 1 intervention
Group B: Knaster hempPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Subjective drug effects
Subjective drug effects will be measured via the drug effect questionnaire
Time frame
Immediately upon inhalation, up to 3.5 hours post administration2
THC concentration in blood
Blood sample will be taken to assess THC concentration in blood.
Time frame
Baseline (-0.5 hour) and at set time periods up to 3.5 hours post administration3
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
Time frame
Immediately upon inhalation, up to 3.5 hours post administration4
Sensitivity to cannabis reinforcement
Measured via the sensitivity to cannabis reinforcement questionnaire,
Time frame
Immediately upon inhalation, up to 3.5 hours post administrationSecondary outcomes
1
Interoception
The Heart rate discrimination task will be used to assess interoception.
Time frame
+1 hr 15 minutes after administration2
Subjective experience of pain
The cold pressor task will be used. Pain is assessed via how many seconds participants can keep their hand in the water.
Time frame
+2.5 hours after administration3
Attention
attention will be assessed via the psychomotor vigilance test
Time frame
Immediately upon inhalation, up to 3.5 hours post administration4
Information processing speed
Will be assessed via the digit symbol substitution test
Time frame
Immediately upon inhalation, up to 3.5 hours post administrationOther outcomes
1
Metacognition
Before and after each task, participants will be shown full text prompts explaining the task, and asking them how well they believe they will do on the task, and upon completion, how well they think they performed.
Time frame
Immediately upon inhalation, up to 3.5 hours post administration2
Inflammatory cytokines
Blood samples will be collected to measure inflammatory cytokine levels
Time frame
At baseline (-0.5) and 3.5 hours after treatment administrationSponsors and contacts
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Source ClinicalTrials.gov