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

Sponsor

University Hospital, Basel, Switzerland (Other)

Overall Status

Completed

CT.gov ID

NCT03604744

Collaborator

(none)

Enrollment

Location

Arms

24.6

Actual Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

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: LSD Drug: Psilocybin Drug: Psilocybin	Early Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

28 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 :

Mar 27, 2019

Actual Primary Completion Date :

Apr 10, 2021

Actual Study Completion Date :

Apr 15, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Altered states of consciousness [18 Months]
total 5D-ASC score (5-Dimensional Altered States of Consciousness Rating Scale)

Secondary Outcome Measures

Subjective effects assessed by VAS [18 Months]
VAS (Visual analog scale)
Subjective effects assessed by AMRS scales [18 Months]
AMRS scales (Adjective mood Rating scale)
Psychotomimetic effects [18 Months]
ESI (Eppendorf Schizophrenia Inventory)
Mystical-type experiences assessed by SCQ [18 Months]
SCQ (States of consciousness questionnaire)
Mystical-type experiences assessed by MS scales [18 Months]
MS scales (Mysticism scale)
Effects on emotion processing [18 Months]
FERT (Face Emotion Recognition Task)
Autonomic effects assessed by heart rate [18 Months]
Heart rate
Autonomic effects assessed by blood pressure [18 Months]
Blood pressure (diastolic and systolic)
Autonomic effects assessed by body temperature [18 Months]
Body temperature

Other Outcome Measures

Plasma levels of LSD and psilocin [18 Months]
assessment of plasma levels of LSD and psilocin

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Age between 25 and 65 years.
Understanding of the German language.
Understanding the procedures and the risks that are associated with the study.
Participants must be willing to adhere to the protocol and sign the consent form.
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 48 h after substance administration.
Women of childbearing potential must have a negative pregnancy test at the beginning of the study. Pregnancy tests are repeated before each study session.
Women of childbearing potential must be willing to use double-barrier birth control
Body mass index 18-29 kg/m2.

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Pharmacology & Toxicology, University Hospital Basel	Basel		Switzerland	4056

Sponsors and Collaborators

University Hospital, Basel, Switzerland

Investigators

Principal Investigator: Matthias E Liechti, MD, MAS, University Hospital, Basel, Switzerland

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Basel, Switzerland

ClinicalTrials.gov Identifier:

NCT03604744

Other Study ID Numbers:

BASEC 2018-00985

First Posted:

Jul 27, 2018

Last Update Posted:

Apr 27, 2021

Last Verified:

Apr 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Psilocybin

Study Results

No Results Posted as of Apr 27, 2021