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Trial record 11 of 14 for:    psilocybin | Psilocybin | First posted from 07/30/2018 to 03/21/2020

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04227756
Recruitment Status : Not yet recruiting
First Posted : January 14, 2020
Last Update Posted : January 14, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

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 mg mescaline, and 4) placebo.

Condition or disease Intervention/treatment Phase
Healthy Drug: LSD Drug: Psilocybin Drug: Mescaline Other: Placebo Phase 1

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 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
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
Official Title: Comparative Acute Effects of LSD, Psilocybin and Mescaline in a Random-Order Placebo-Controlled Cross-Over Study in Healthy Subjects
Estimated Study Start Date : April 1, 2020
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Peyote

Arm Intervention/treatment
Experimental: LSD-100
Cross-over within-subject design with all treatment conditions, separated by a wash-out phase of at least 10 days
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

Active Comparator: Psilocybin-20
Cross-over within-subject design with all treatment conditions, separated by a wash-out phase of at least 10 days
Drug: Psilocybin
Psilocybin 20 mg per os, single dose

Active Comparator: Mescaline-300
Cross-over within-subject design with all treatment conditions, separated by a wash-out phase of at least 10 days
Drug: Mescaline
Mescaline 300 mg per os, single dose

Placebo Comparator: Placebo
Cross-over within-subject design with all treatment conditions, separated by a wash-out phase of at least 10 days
Other: Placebo
Placebo (Mannitol)




Primary Outcome Measures :
  1. 5 Dimensions of Altered States of Consciousness (5D-ASC) [ Time Frame: 18 months ]
    5D-ASC subscale ratios

  2. fMRI resting state functional connectivity (RSFC) [ Time Frame: 18 months ]
    Spontaneous low-frequency fluctuations in BOLD signal during resting state


Secondary Outcome Measures :
  1. 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

  2. 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")

  3. Blood pressure [ Time Frame: 18 months ]
    Assessment of sympathetic activation

  4. Heart rate [ Time Frame: 18 months ]
    Assessment of sympathetic activation

  5. Body temperature [ Time Frame: 18 months ]
    Assessment of sympathetic activation

  6. Pupil size [ Time Frame: 18 months ]
    Assessment of sympathetic activation

  7. Drug plasma levels [ Time Frame: 18 months ]
    Plasma levels of investigational drugs

  8. Oxytocin levels [ Time Frame: 18 months ]
    Levels of oxytocin in blood plasma

  9. Blood-derived neurotrophic factor (BDNF) [ Time Frame: 18 months ]
    Blood plasma levels of BDNF

  10. Renal clearance values [ Time Frame: 18 months ]
    Renal clearance values of investigational drugs through urine recovery

  11. NEO-Five-Factor-Inventory (NEO-FFI) [ Time Frame: 18 months ]
    Assesses personality traits

  12. Freiburger Persönlichkeitsinventar (FPI) [ Time Frame: 18 months ]
    Assesses personality traits

  13. Saarbrücker Persönlichkeitsfragebogen (SPF) [ Time Frame: 18 months ]
    Assesses personality traits

  14. 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"

  15. 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

  16. 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"

  17. 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"

  18. Arnett Inventory of Sensation Seeking (AISS-d) [ Time Frame: 18 months ]
    Assesses personality traits



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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:

  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04227756


Contacts
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Contact: Matthias E. Liechti, Prof. 061 328 68 68 ext +41 matthias.liechti@usb.ch
Contact: Laura Ley, MSc 061 328 77 42 ext +41 laura.ley@usb.ch

Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
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Principal Investigator: Matthias E. Liechti, Prof. University Hospital, Basel, Switzerland

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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT04227756    
Other Study ID Numbers: BASEC 2019-02023
First Posted: January 14, 2020    Key Record Dates
Last Update Posted: January 14, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Psilocybin
Mescaline
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action