Comparative Acute Effects of LSD, Psilocybin and Mescaline
Double-blind, placebo-controlled, 4-period crossover study (n≈32) comparing single doses of LSD 100 µg, psilocybin 20 mg, mescaline 300/500 mg and placebo in healthy volunteers to characterise acute subjective, physiological and neural effects.
Detailed Description
The LPM study is a double-blind, placebo-controlled, four-period crossover in healthy volunteers comparing single oral doses of LSD (100 µg), psilocybin (20 mg), mescaline (300 or 500 mg) and placebo to determine whether these serotonergic hallucinogens produce qualitatively similar subjective alterations and brain activity patterns.
Outcomes include validated psychometric measures of subjective experience, physiological monitoring, and magnetic resonance imaging to investigate psychological, physiological and neuronal variables associated with acute psychedelic effects.
Study Protocol
Preparation
Dosing
Integration
Study Arms & Interventions
LSD-100
experimentalCross-over within-subject design with all treatment conditions, separated by a wash-out phase of at least 10 days
Interventions
- LSD100 µgvia Oral• single dose
100 µg (0.1 mg)
Psilocybin-20
active comparatorCross-over within-subject design with all treatment conditions, separated by a wash-out phase of at least 10 days
Interventions
- Psilocybin20 mgvia Oral• single dose
Mescaline-300/500
active comparatorCross-over within-subject design with all treatment conditions, separated by a wash-out phase of at least 10 days
Interventions
- Mescaline300 - 500 mgvia Oral• single dose
300 or 500 mg
Placebo
inactiveCross-over within-subject design with all treatment conditions, separated by a wash-out phase of at least 10 days
Interventions
- Placebovia Oral• single dose
Mannitol
Participants
Inclusion Criteria
- Inclusion Criteria:
- 1. Age between 25 and 65 years old
- 2. Sufficient understanding of the German language
- 3. Understanding of procedures and risks associated with the study
- 4. Willing to adhere to the protocol and signing of the consent form
- 5. Willing to refrain from the consumption of illicit psychoactive substances during the study
- 6. Abstaining from xanthine-based liquids from the evenings prior to the study sessions to the end of the study days
- 7. Willing not to operate heavy machinery within 48 hours after substance administration
- 8. Willing to use double-barrier birth control throughout study participation
- 9. Body mass index between 18-29 kg/m2
Exclusion Criteria
- Exclusion Criteria:
- 1. Chronic or acute medical condition
- 2. Current or previous major psychiatric disorder
- 3. Psychotic disorder or bipolar disorder in first-degree relatives
- 4. Hypertension (>140/90 mmHg) or hypotension (SBP<85 mmHg)
- 5. Hallucinogenic substance use (not including cannabis) more than 20 times or any time within the previous two months
- 6. Pregnancy or current breastfeeding
- 7. Participation in another clinical trial (currently or within the last 30 days)
- 8. Use of medication that may interfere with the effects of the study medication
- 9. Tobacco smoking (>10 cigarettes/day)
- 10. Consumption of alcoholic beverages (>20 drinks/week)
- 11. Failure of MRI-related criteria
Study Details
- StatusCompleted
- PhasePhase I
- Typeinterventional
- DesignRandomizedquadruple Blind
- Target Enrollment32 participants
- TimelineStart: 2020-05-19End: 2022-12-31
- Compounds
- Topic