Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2025-12-25 @ 9:27 PM
Study NCT ID:
NCT04227756
Status:
COMPLETED
Last Update Posted:
2024-01-24
First Post:
2020-01-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparative Acute Effects of LSD, Psilocybin and Mescaline
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008238', 'term': 'Lysergic Acid Diethylamide'}, {'id': 'D011562', 'term': 'Psilocybin'}, {'id': 'D008635', 'term': 'Mescaline'}], 'ancestors': [{'id': 'D008237', 'term': 'Lysergic Acid'}, {'id': 'D004873', 'term': 'Ergolines'}, {'id': 'D004876', 'term': 'Ergot Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D014363', 'term': 'Tryptamines'}, {'id': 'D054836', 'term': 'Indolizidines'}, {'id': 'D007212', 'term': 'Indolizines'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Double-blind, placebo-controlled, 4-period cross-over design with four treatment conditions'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2022-09-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-23', 'studyFirstSubmitDate': '2020-01-07', 'studyFirstSubmitQcDate': '2020-01-09', 'lastUpdatePostDateStruct': {'date': '2024-01-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '5 Dimensions of Altered States of Consciousness (5D-ASC)', 'timeFrame': '18 months', 'description': '5D-ASC subscale ratios'}, {'measure': 'fMRI resting state functional connectivity (RSFC)', 'timeFrame': '18 months', 'description': 'Spontaneous low-frequency fluctuations in BOLD signal during resting state'}], 'secondaryOutcomes': [{'measure': 'Visual Analog Scale (VAS)', 'timeFrame': '18 months', 'description': 'Assesses the intensity and duration of subjective effects on a scale from 0% - 100% with higher scores representing more intense effects'}, {'measure': 'States of Consciousness questionnaire (SCQ)', 'timeFrame': '18 months', 'description': '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")'}, {'measure': 'Blood pressure', 'timeFrame': '18 months', 'description': 'Assessment of sympathetic activation'}, {'measure': 'Heart rate', 'timeFrame': '18 months', 'description': 'Assessment of sympathetic activation'}, {'measure': 'Body temperature', 'timeFrame': '18 months', 'description': 'Assessment of sympathetic activation'}, {'measure': 'Pupil size', 'timeFrame': '18 months', 'description': 'Assessment of sympathetic activation'}, {'measure': 'Drug plasma levels', 'timeFrame': '18 months', 'description': 'Plasma levels of investigational drugs'}, {'measure': 'Oxytocin levels', 'timeFrame': '18 months', 'description': 'Levels of oxytocin in blood plasma'}, {'measure': 'Blood-derived neurotrophic factor (BDNF)', 'timeFrame': '18 months', 'description': 'Blood plasma levels of BDNF'}, {'measure': 'Renal clearance values', 'timeFrame': '18 months', 'description': 'Renal clearance values of investigational drugs through urine recovery'}, {'measure': 'NEO-Five-Factor-Inventory (NEO-FFI)', 'timeFrame': '18 months', 'description': 'Assesses personality traits'}, {'measure': 'Freiburger Persönlichkeitsinventar (FPI)', 'timeFrame': '18 months', 'description': 'Assesses personality traits'}, {'measure': 'Saarbrücker Persönlichkeitsfragebogen (SPF)', 'timeFrame': '18 months', 'description': 'Assesses personality traits'}, {'measure': 'Adjective Mood Rating Scale (AMRS)', 'timeFrame': '18 months', 'description': 'Assesses the occurrence and intensity of 60 moods on a 4-point Likert scale ranging from "not at all" to "extremely"'}, {'measure': 'Mysticism Scale (MS)', 'timeFrame': '18 months', 'description': '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'}, {'measure': 'Elliot Humility Scale (EHS)', 'timeFrame': '18 months', 'description': 'Assesses the personality trait humility through 13 items on a 5-point Likert scale ranging from "strongly disagree" to "strongly agree"'}, {'measure': 'Jankowski Humility Scale (JHS)', 'timeFrame': '18 months', 'description': 'Assesses the personality trait humility through 18 items on a 5-point Likert scale ranging from "not at all" to "strongly"'}, {'measure': 'Arnett Inventory of Sensation Seeking (AISS-d)', 'timeFrame': '18 months', 'description': 'Assesses personality traits'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '40658345', 'type': 'DERIVED', 'citation': 'Mueller L, Klaiber A, Ley L, Becker AM, Thomann J, Luethi D, Schmid Y, Liechti ME. Pharmacokinetics, Pharmacodynamics, and Urinary Recovery of Oral Mescaline Hydrochloride in Healthy Participants. Clin Pharmacokinet. 2025 Oct;64(10):1495-1506. doi: 10.1007/s40262-025-01544-x. Epub 2025 Jul 14.'}, {'pmid': '37231080', 'type': 'DERIVED', 'citation': 'Ley L, Holze F, Arikci D, Becker AM, Straumann I, Klaiber A, Coviello F, Dierbach S, Thomann J, Duthaler U, Luethi D, Varghese N, Eckert A, Liechti ME. Comparative acute effects of mescaline, lysergic acid diethylamide, and psilocybin in a randomized, double-blind, placebo-controlled cross-over study in healthy participants. Neuropsychopharmacology. 2023 Oct;48(11):1659-1667. doi: 10.1038/s41386-023-01607-2. Epub 2023 May 25.'}]}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age between 25 and 65 years old\n2. Sufficient understanding of the German language\n3. Understanding of procedures and risks associated with the study\n4. Willing to adhere to the protocol and signing of the consent form\n5. Willing to refrain from the consumption of illicit psychoactive substances during the study\n6. Abstaining from xanthine-based liquids from the evenings prior to the study sessions to the end of the study days\n7. Willing not to operate heavy machinery within 48 hours after substance administration\n8. Willing to use double-barrier birth control throughout study participation\n9. Body mass index between 18-29 kg/m2\n\nExclusion Criteria:\n\n1. Chronic or acute medical condition\n2. Current or previous major psychiatric disorder\n3. Psychotic disorder or bipolar disorder in first-degree relatives\n4. Hypertension (\\>140/90 mmHg) or hypotension (SBP\\<85 mmHg)\n5. Hallucinogenic substance use (not including cannabis) more than 20 times or any time within the previous two months\n6. Pregnancy or current breastfeeding\n7. Participation in another clinical trial (currently or within the last 30 days)\n8. Use of medication that may interfere with the effects of the study medication\n9. Tobacco smoking (\\>10 cigarettes/day)\n10. Consumption of alcoholic beverages (\\>20 drinks/week)\n11. Failure of MRI-related criteria'}, 'identificationModule': {'nctId': 'NCT04227756', 'acronym': 'LPM', 'briefTitle': 'Comparative Acute Effects of LSD, Psilocybin and Mescaline', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'Comparative Acute Effects of LSD, Psilocybin and Mescaline in a Random-Order Placebo-Controlled Cross-Over Study in Healthy Subjects', 'orgStudyIdInfo': {'id': 'BASEC 2019-02023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LSD-100', 'description': 'Cross-over within-subject design with all treatment conditions, separated by a wash-out phase of at least 10 days', 'interventionNames': ['Drug: LSD']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Psilocybin-20', 'description': 'Cross-over within-subject design with all treatment conditions, separated by a wash-out phase of at least 10 days', 'interventionNames': ['Drug: Psilocybin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Mescaline-300/500', 'description': 'Cross-over within-subject design with all treatment conditions, separated by a wash-out phase of at least 10 days', 'interventionNames': ['Drug: Mescaline']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Cross-over within-subject design with all treatment conditions, separated by a wash-out phase of at least 10 days', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'LSD', 'type': 'DRUG', 'description': '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', 'armGroupLabels': ['LSD-100']}, {'name': 'Psilocybin', 'type': 'DRUG', 'description': 'Psilocybin 20 mg per os, single dose', 'armGroupLabels': ['Psilocybin-20']}, {'name': 'Mescaline', 'type': 'DRUG', 'description': 'Mescaline 300 mg or 500 mg per os, single dose', 'armGroupLabels': ['Mescaline-300/500']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo (Mannitol)', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4031', 'city': 'Basel', 'state': 'Canton of Basel-City', 'country': 'Switzerland', 'facility': 'University Hospital Basel, Clinical Trial Unit', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Matthias E. Liechti, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Basel, Switzerland'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}