The effects of three low morning and evening doses of LSD on mood, biological and psychological measures of sleep, neuroplasticity, and well-being
- Conditions
- neuroplasticiteit, slaap en gemoedstoestandsleep and mood
- Registration Number
- NL-OMON52249
- Lead Sponsor
- niversiteit Maastricht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 30
• Written Informed Consent
• Understanding the procedures and the risks associated with the study.
• At least 18 years of age
• 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.
• Participants are asked to not make any substantial changes in their diet.
• Participants must be willing to comply with guidelines regarding their
bedtime.
• Normal weight, body mass index (weight/height2) between 18 and 28 kg/m2
• 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)
• Experience with a full dose of a psychedelic within the last three months
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary objective is to investigate the effects of three repeated morning vs<br /><br>evening doses of LSD (20 µg) on mood (self-rated). </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary objectives are to investigate the effects of three repeated morning<br /><br>vs evening doses of LSD (20 µg) on [1] neuroplasticity (BDNF levels in blood<br /><br>samples), [2] sleep parameters, [3] cognitive performance measures of different<br /><br>memory types, [4] emotional attention, [5] emotion regulation [6] markers of<br /><br>well-being (cytokines in blood samples and self-rated questionnaire). Tertiary<br /><br>objectives are to investigate the effects of three repeated morning vs evening<br /><br>doses of LSD (20 µg) on [1] cortisol levels (blood samples), and [2]<br /><br>endocannabinoid concentrations (blood samples).</p><br>