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Direct Comparison of Altered States of Consciousness Induced by LSD and Psilocybin (LSD-psilo)

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ClinicalTrials.gov Identifier: NCT03604744
Recruitment Status : Recruiting
First Posted : July 27, 2018
Last Update Posted : April 2, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Brief Summary:
LSD (lysergic acid diethylamide) and psilocybin (the active substance in "magic mushrooms") are widely used for recreational purposes. Both substances are also increasingly used in psychiatric and psychological research to induce and investigate alterations in waking consciousness and associated brain functions (functional brain imaging, "model psychosis") . However, it has never been studied whether there are differences in the alterations in mind produced by these two substances. Both LSD and psilocybin are thought to induce hallucinations primarily via stimulation of the 5-HT2A receptor. However, there are differences in the receptor activation profiles between the two substances that may also induce different subjective effects. LSD potently stimulates the 5-HT2A receptor but also 5-HT2B/C, 5-HT1 and D1-3 receptors . Psilocin (the active metabolite of the prodrug psilocybin) also stimulates the 5-HT2A receptor but additionally inhibits the 5-HT transporter. In contrast to LSD, psilocybin has no affinity for D2 receptors. Both substances are used in neuroscience as pharmacological tools. However, there are no modern studies comparing these two substances directly within the same clinical study and research subjects and using validated psychometric tools. Therefore, the investigators will compare the acute effects of LSD, psilocybin and placebo.

Condition or disease Intervention/treatment Phase
Healthy Drug: LSD Drug: Psilocybin Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Direct Comparison of Altered States of Consciousness Induced by LSD and Psilocybin in a Random-order Placebo-controlled Cross-over Study in Healthy Subjects
Actual Study Start Date : March 27, 2019
Estimated Primary Completion Date : April 1, 2020
Estimated Study Completion Date : April 1, 2020

Arm Intervention/treatment
Experimental: LSD-100, LSD-200, Psilocybin-15, Psilocybin-30, Placebo
Cross-over within-subjects design with all treatment conditions, separated by a wash-out phase
Drug: LSD
LSD 0.1 mg per os, single dose

Drug: LSD
LSD 0.2 mg per os, single dose

Drug: Psilocybin
Psilocybin 15 mg per os, single dose

Drug: Psilocybin
Psilocybin 30 mg per os, single dose

Placebo Comparator: LSD-200, Psilocybin-15, Psilocybin-30, Placebo, LSD-100
Cross-over within-subjects design with all treatment conditions, separated by a wash-out phase
Drug: LSD
LSD 0.1 mg per os, single dose

Drug: LSD
LSD 0.2 mg per os, single dose

Drug: Psilocybin
Psilocybin 15 mg per os, single dose

Drug: Psilocybin
Psilocybin 30 mg per os, single dose

Placebo Comparator: Psilocybin-15, Psilocybin-30, Placebo, LSD-100, LSD-200
Cross-over within-subjects design with all treatment conditions, separated by a wash-out phase
Drug: LSD
LSD 0.1 mg per os, single dose

Drug: LSD
LSD 0.2 mg per os, single dose

Drug: Psilocybin
Psilocybin 15 mg per os, single dose

Drug: Psilocybin
Psilocybin 30 mg per os, single dose

Placebo Comparator: Psilocybin-30, Placebo, LSD-100, LSD-200, Psilocybin-15
Cross-over within-subjects design with all treatment conditions, separated by a wash-out phase
Drug: LSD
LSD 0.1 mg per os, single dose

Drug: LSD
LSD 0.2 mg per os, single dose

Drug: Psilocybin
Psilocybin 15 mg per os, single dose

Drug: Psilocybin
Psilocybin 30 mg per os, single dose

Placebo Comparator: Placebo, LSD-100, LSD-200, Psilocybin-15, Psilocybin-30
Cross-over within-subjects design with all treatment conditions, separated by a wash-out phase
Drug: LSD
LSD 0.1 mg per os, single dose

Drug: LSD
LSD 0.2 mg per os, single dose

Drug: Psilocybin
Psilocybin 15 mg per os, single dose

Drug: Psilocybin
Psilocybin 30 mg per os, single dose




Primary Outcome Measures :
  1. Altered states of consciousness [ Time Frame: 18 Months ]
    total 5D-ASC score (5-Dimensional Altered States of Consciousness Rating Scale)


Secondary Outcome Measures :
  1. Subjective effects assessed by VAS [ Time Frame: 18 Months ]
    VAS (Visual analog scale)

  2. Subjective effects assessed by AMRS scales [ Time Frame: 18 Months ]
    AMRS scales (Adjective mood Rating scale)

  3. Psychotomimetic effects [ Time Frame: 18 Months ]
    ESI (Eppendorf Schizophrenia Inventory)

  4. Mystical-type experiences assessed by SCQ [ Time Frame: 18 Months ]
    SCQ (States of consciousness questionnaire)

  5. Mystical-type experiences assessed by MS scales [ Time Frame: 18 Months ]
    MS scales (Mysticism scale)

  6. Effects on emotion processing [ Time Frame: 18 Months ]
    FERT (Face Emotion Recognition Task)

  7. Autonomic effects assessed by heart rate [ Time Frame: 18 Months ]
    Heart rate

  8. Autonomic effects assessed by blood pressure [ Time Frame: 18 Months ]
    Blood pressure (diastolic and systolic)

  9. Autonomic effects assessed by body temperature [ Time Frame: 18 Months ]
    Body temperature


Other Outcome Measures:
  1. Plasma levels of LSD and psilocin [ Time Frame: 18 Months ]
    assessment of plasma levels of LSD and psilocin



Information from the National Library of Medicine

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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.
  2. Understanding of the German language.
  3. Understanding the procedures and the risks that are associated with the study.
  4. Participants must be willing to adhere to the protocol and sign the consent form.
  5. Participants must be willing to refrain from taking illicit psychoactive substances during the study.
  6. 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.
  7. Participants must be willing not to drive a traffic vehicle or to operate machines within 48 h after substance administration.
  8. Women of childbearing potential must have a negative pregnancy test at the beginning of the study. Pregnancy tests are repeated before each study session.
  9. Women of childbearing potential must be willing to use double-barrier birth control
  10. Body mass index 18-29 kg/m2.

Exclusion Criteria:

  1. Chronic or acute medical condition
  2. Current or previous major psychiatric disorder
  3. Psychotic disorder in first-degree relatives
  4. Illicit substance use (with the exception of cannabis) more than 10 times or any time within the previous two months.
  5. Pregnant or nursing women.
  6. Participation in another clinical trial (currently or within the last 30 days)
  7. Use of medications that may interfere with the effects of the study medications (any psychiatric medications)
  8. Tobacco smoking (>10 cigarettes/day)
  9. Consumption of alcoholic drinks (>10/week)
  10. Bodyweight < 50 kg

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): NCT03604744


Contacts
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Contact: Matthias E Liechti, MD, MAS 61 328 68 68 ext +41 matthias.liechti@usb.ch
Contact: Friederike Holze, MSc 61 556 54 37 ext +41 friederike.holze@usb.ch

Locations
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Switzerland
Clinical Pharmacology & Toxicology, University Hospital Basel Recruiting
Basel, Switzerland, 4056
Contact: Matthias E Liechti, Prof.Dr.med.    +41 61 265 88 68 ext +41    matthias.liechti@usb.ch   
Contact: Friederike Holze, MSc    +41 61 556 54 37 ext +41    friederike.holze@usb.ch   
Principal Investigator: Matthias E Liechti, MD         
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
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Principal Investigator: Matthias E Liechti, MD, MAS University Hospital, Basel, Switzerland

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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT03604744     History of Changes
Other Study ID Numbers: BASEC 2018-00985
First Posted: July 27, 2018    Key Record Dates
Last Update Posted: April 2, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs