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…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
drug effects
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the drug-induced change in subjective state,
cognition, and pharmacokinetics across the menstrual cycle, when comparing
cannabis to placebo.
Secondary outcome
Secondary parameters include changes in interoception and pain. Tertiary
parameters include changes in inflammatory cytokine expression.
Background summary
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. This study is the first to systematically
determine whether the cannabis response in human females is related to SH
fluctuations throughout the menstrual cycle.
Study objective
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.
Study design
Acute influences of cannabis 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. A seven-day washout period will precede each
drug condition.
Intervention
Participants will receive three doses of cannabis (300 µg THC/kg bodyweight),
and three doses of placebo on separate testing days, during specific phases of
their menstrual cycle.
Study burden and risks
Volunteers will be enrolled for minimally nine weeks, which will include seven
lab visits consisting of a medical screening, six treatment administrations,
and undergoing two different treatment conditions in total. During the first
lab visit, participants will independently undergo a full medical screening
(medical history review, laboratory exam, electrocardiogram, and blood and
urine samples will be taken) by a licensed physician ensuring their safety. The
following six lab visits consist of the official testing days, which will be
six acute testing days in which they are given the drug treatment. In order to
plan these testing days within the specific phase of the menstrual cycle,
participants will be asked to report when their menstrual cycle starts and
finishes to the researchers, and to track levels of luteinizing hormone in
their urine at home for a maximum of 7 days in their cycle.
During each testing day, participants will inhale a placebo or cannabis vapor.
Up until 3.5 hours after administration, participants will be requested to
indicate how they feel and perform cognitive tasks. Blood samples will also be
taken at regular intervals. In addition, participants will fill in
questionnaires regarding their subjective drug experience. The acute drug
testing days will be interspersed by 7 days, to allow for a washout period.
Over the course of the medical examination and the lab visits, participants
will give a total of 397 ml of blood. The maximum they will give per visit is
64 ml. In case they experience complaints, the medical supervisor will be
contacted. The total discomfort experienced by the volunteer is minimal when
all precautions are taken into account.
Universiteitssingel 40
Maastricht 6229
NL
Universiteitssingel 40
Maastricht 6229
NL
Listed location countries
Age
Inclusion criteria
To be eligible to participate in this study, a participant must meet all the
following 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
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
* 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)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL87464.068.24 |