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Comparative Acute Effects of LSD, Psilocybin and Mescaline (LPM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04227756
Recruitment Status : Active, not recruiting
First Posted : January 14, 2020
Last Update Posted : March 31, 2022
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Tracking Information
First Submitted Date  ICMJE January 7, 2020
First Posted Date  ICMJE January 14, 2020
Last Update Posted Date March 31, 2022
Actual Study Start Date  ICMJE May 19, 2020
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 9, 2020)
  • 5 Dimensions of Altered States of Consciousness (5D-ASC) [ Time Frame: 18 months ]
    5D-ASC subscale ratios
  • fMRI resting state functional connectivity (RSFC) [ Time Frame: 18 months ]
    Spontaneous low-frequency fluctuations in BOLD signal during resting state
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 9, 2020)
  • Visual Analog Scale (VAS) [ Time Frame: 18 months ]
    Assesses the intensity and duration of subjective effects on a scale from 0% - 100% with higher scores representing more intense effects
  • States of Consciousness questionnaire (SCQ) [ Time Frame: 18 months ]
    Assesses the emergence and intensity of phenomenons occurring in altered states of consciousness on a 6-point Likert scale ranging from 0 ("not at all") to 5 ("extremely")
  • Blood pressure [ Time Frame: 18 months ]
    Assessment of sympathetic activation
  • Heart rate [ Time Frame: 18 months ]
    Assessment of sympathetic activation
  • Body temperature [ Time Frame: 18 months ]
    Assessment of sympathetic activation
  • Pupil size [ Time Frame: 18 months ]
    Assessment of sympathetic activation
  • Drug plasma levels [ Time Frame: 18 months ]
    Plasma levels of investigational drugs
  • Oxytocin levels [ Time Frame: 18 months ]
    Levels of oxytocin in blood plasma
  • Blood-derived neurotrophic factor (BDNF) [ Time Frame: 18 months ]
    Blood plasma levels of BDNF
  • Renal clearance values [ Time Frame: 18 months ]
    Renal clearance values of investigational drugs through urine recovery
  • NEO-Five-Factor-Inventory (NEO-FFI) [ Time Frame: 18 months ]
    Assesses personality traits
  • Freiburger Persönlichkeitsinventar (FPI) [ Time Frame: 18 months ]
    Assesses personality traits
  • Saarbrücker Persönlichkeitsfragebogen (SPF) [ Time Frame: 18 months ]
    Assesses personality traits
  • Adjective Mood Rating Scale (AMRS) [ Time Frame: 18 months ]
    Assesses the occurrence and intensity of 60 moods on a 4-point Likert scale ranging from "not at all" to "extremely"
  • Mysticism Scale (MS) [ Time Frame: 18 months ]
    Assesses the occurrence and intensity of mystical qualities in altered states of consciousness on a 9-point Likert scale ranging from -4 ("extremely inapplicable") to +4 ("extremely applicable"), with higher values indicating a more intense experience
  • Elliot Humility Scale (EHS) [ Time Frame: 18 months ]
    Assesses the personality trait humility through 13 items on a 5-point Likert scale ranging from "strongly disagree" to "strongly agree"
  • Jankowski Humility Scale (JHS) [ Time Frame: 18 months ]
    Assesses the personality trait humility through 18 items on a 5-point Likert scale ranging from "not at all" to "strongly"
  • Arnett Inventory of Sensation Seeking (AISS-d) [ Time Frame: 18 months ]
    Assesses personality traits
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparative Acute Effects of LSD, Psilocybin and Mescaline
Official Title  ICMJE Comparative Acute Effects of LSD, Psilocybin and Mescaline in a Random-Order Placebo-Controlled Cross-Over Study in Healthy Subjects
Brief Summary LSD, psilocybin and mescaline are widely used for recreational and ethnomedical purposes. All three substances are thought to induce prototypical psychedelic effects primarily via stimulation of the 5-HT2A receptor. However, there are differences in the substances' molecular structures and receptor activation profiles which may induce differential subjective effects. To date, there are no modern studies comparing LSD, psilocybin and mescaline directly within the same clinical study and research subjects using validated psychometric tools. Therefore, the LPM-Study compares the acute effects of LSD, psilocybin, mescaline and placebo in a double-blind, placebo-controlled, 4-period cross-over design with four treatment conditions: 1) 100 μg LSD, 2) 20 mg psilocybin, 3) 300 or 500 mg mescaline, and 4) placebo.
Detailed Description LSD (lysergic acid diethylamide), psilocybin (the active substance in "magic mushrooms") and mescaline (the active substance in Peyote and San Pedro cacti) are serotonergic hallucinogens widely used for recreational and/or ethnomedical purposes. LSD, psilocybin and mescaline are thought to induce prototypical psychedelic effects primarily via stimulation of the 5-HT2A receptor. However, there are differences in their molecular structures (LSD: ergoline, psilocybin: tryptamine; mescaline: phenethylamine)and receptor activation profiles which may induce different subjective effects. To date, there are no modern studies comparing these three substances directly within the same clinical study and research subjects using validated psychometric tools. Therefore, the LPM-Study compares the acute effects of LSD, psilocybin, mescaline and placebo in a double-blind, placebo-controlled, 4-period cross-over design with four treatment conditions: 1) 100 μg LSD, 2) 20 mg psilocybin, 3) 300 or 500 mg mescaline, and 4) placebo. The main objective of this study is to determine whether LSD, psilocybin and mescaline produce qualitatively similar subjective alterations of mind and associated brain activity patterns despite their unique receptor activation profiles. The study investigates psychological (psychometry), physiological and neuronal (magnetic resonance imaging) variables. The LPM-Study provides insight into the acute effects profiles of three serotonergic hallucinogens. It will enhance the understanding of psychedelic-induced altered states of consciousness in humans and will be relevant for the fields of psychiatry, psychology, and forensic toxicology.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
Double-blind, placebo-controlled, 4-period cross-over design with four treatment conditions
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: LSD
    LSD 0.1 mg per os, single dose OR Psilocybin 20 mg per os, single dose OR Mescaline 300 mg per os, single dose OR Placebo
  • Drug: Psilocybin
    Psilocybin 20 mg per os, single dose
  • Drug: Mescaline
    Mescaline 300 mg or 500 mg per os, single dose
  • Other: Placebo
    Placebo (Mannitol)
Study Arms  ICMJE
  • Experimental: LSD-100
    Cross-over within-subject design with all treatment conditions, separated by a wash-out phase of at least 10 days
    Intervention: Drug: LSD
  • Active Comparator: Psilocybin-20
    Cross-over within-subject design with all treatment conditions, separated by a wash-out phase of at least 10 days
    Intervention: Drug: Psilocybin
  • Active Comparator: Mescaline-300/500
    Cross-over within-subject design with all treatment conditions, separated by a wash-out phase of at least 10 days
    Intervention: Drug: Mescaline
  • Placebo Comparator: Placebo
    Cross-over within-subject design with all treatment conditions, separated by a wash-out phase of at least 10 days
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: January 9, 2020)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2022
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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:

  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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04227756
Other Study ID Numbers  ICMJE BASEC 2019-02023
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party University Hospital, Basel, Switzerland
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University Hospital, Basel, Switzerland
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Matthias E. Liechti, Prof. University Hospital, Basel, Switzerland
PRS Account University Hospital, Basel, Switzerland
Verification Date March 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP