The present study explores the acute and sub-acute effects of repeated-dosing schedule of small doses of LSD (15 µg) on subjective and cognitive effects compared to placebo.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
subjectieve effecten, cognitief functioneren
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective is to examine the possible positive mood and positive
subjective effects following repeated doses of 15 mcg LSD compared to placebo.
Secondary outcome
The secondary objective is to examine the possible induced cognitive
performance and increase in neuroplasticity following repeated doses of 15 mcg
LSD compared to placebo.
Background summary
LSD is a psychedelic substance that is used recreationally because of its
effects on consciousness. More specifically, LSD induces acute transient
alterations in waking consciousness including visual perceptual alterations,
audio-visual synesthesia, derealization and depersonalization. Recent
experimental studies documented marked changes in perception at a moderate (100
µg orally or 75 µg intravenously) or high 200 µg oral dose of LSD in healthy
volunteers. Recently, the use of low doses of LSD twice a week over a longer
period of time as so-called LSD microdosing to enhance mood, creativity, and/or
performance has been observed. The acute subjective effects of such low doses
(between 5 and 20 µg) have recently been investigated in a placebo-controlled
dose-finding study, which has shown that doses between 10 and 20 micrograms do
show a difference compared to the placebo. However, the subjective and
cognitive effects of repeated low doses of LSD (15 µg) have not yet been
investigated in placebo-controlled studies with validated psychometric
instruments. It is unclear whether repeated doses of LSD produce subjective
effects distinct from placebo.
Study objective
The present study explores the acute and sub-acute effects of repeated-dosing
schedule of small doses of LSD (15 µg) on subjective and cognitive effects
compared to placebo.
Study design
The present study uses a double-blind, randomized, placebo-controlled,
between-subjects design. Participants will receive placebo or 4 microdoses of
LSD (15 µg).
Intervention
4 times a placebo or 4 times 15 µg of LSD.
Study burden and risks
Participants will visit our lab 7 times during 5 weeks. Before the first study
day, subjects will come for a screening visit. This includes a full medical
screening by a licensed physician (medical history review, laboratory
screening, electrocardiogram recording). Then the participant will come in for
a training session, were the participant is familiarized with all the task
procedures. A baseline visit, 2 microdosing days (intake of 15 µg LSD or
placebo) and the follow-up visit consist of taking a blood sample (10 ml),
completing computer tasks, filling out questionnaires and EEG measurements. The
other 2 short microdosing visits consist of completing questionnaires and
taking 15 µg of LSD or placebo. 4 weeks after the last intake of the LSD or
placebo, participants are asked to complete a few questionnaires.
Universiteitssingel 40
Maastricht 6229 ER
NL
Universiteitssingel 40
Maastricht 6229 ER
NL
Listed location countries
Age
Inclusion criteria
* Proficient knowledge of the English language
* Written Informed Consent
* Understanding the procedures and the risks associated with the study.
* Age between 18 and 65 years
* Absence of any major medical condition as determined by medical examination
and laboratory analysis
* Absence of any major psychological condition as determined by medical
examination
* Free from psychotropic medication
* 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 drink 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.
* Normal weight , body mass index (weight/height2) between 18 and 28 kg/m2
Exclusion criteria
* Having used a psychedelic substance (regular dose) such as LSD, psilocybin,
ayahuasca, DMT, Salvinorin, Mescaline, MDMA, NBOMe, 2Cs or any other
psychedelic drug within the past 3 months.
* History of drug addiction (determined by the medical questionnaire, drug
questionnaire and medical examination)
* Previous experience of serious side effects to psychedelic drugs (anxiety or
panic attacks)
* Pregnancy or lactation
* Hypertension (diastolic > 90 mmHg; systolic > 160 mmHg)
* Current or history of psychiatric disorder (determined by the medical
questionnaire and medical examination)
* Psychotic disorder in first-degree relatives
* Any chronic or acute medical condition
* History of cardiac dysfunctions (arrhythmia, ischemic heart disease,*)
* For women: no use of a reliable contraceptive
* 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 | NL70508.068.19 |