The present study explores the dose-response relationship in LSD-induced subjective and cognitive effects using small doses of LSD (5, 10, and 20 µg) compared to placebo.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
subjective effects, cognitive functioning
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The study hypothesis is that higher doses of LSD will be associated with
increasingly greater and potentially also qualitatively different subjective
effects compared to placebo. An additional study parameter is the change in
cognitive performance under the influence of LSD compared to placebo.
Secondary outcome
The secondary objective is to characterize the dose-response relationship in
LSD-induced changes in cognitive performance.
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 as so-called LSD microdosing
to enhance mood, creativity, and/or performance has been observed. However, the
subjective effects of such low doses (between 5 to 20 µg) have not yet been
studied in modern studies using validated psychometric tools. It is unclear
whether such doses produce any subjective effects and if whether these effects
are similar and just weaker than those induced by a higher dose and/or whether
there are dose-related differences in the response.
Study objective
The present study explores the dose-response relationship in LSD-induced
subjective and cognitive effects using small doses of LSD (5, 10, and 20 µg)
compared to placebo.
Study design
The present study uses a double-blind, randomized, placebo controlled,
crossover design. Participants will placebo and 3 microdoses of LSD (5, 10,
and 20 µg).
Intervention
Placebo and 5, 10, 20 µg of LSD in randomized order.
Study burden and risks
Participants will visit our lab 5 times during 5 weeks. Before the first study
day, subject will come for a screening visit. This includes a full medical
screening by a licensed physician (medical history review, laboratory
screening, electrocardiogram recording). The study visits will consist of
taking the study treatment (5, 10, and 20 µg of LSD or placebo), taking blood
samples, completing computer tasks and filling out questionnaires.
Universiteitssingel 40
Maastricht 6229 ER
NL
Universiteitssingel 40
Maastricht 6229 ER
NL
Listed location countries
Age
Inclusion criteria
* Previous experience with a psychedelic drug, but not within the past 3 months.
* Proficient knowledge of the English language
* Written Informed Consent
* Understanding the procedures and the risks associated with the study.
* Age between 18 and 40 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
* 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 > 140 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 | NL64747.068.18 |