Comparison of LSD-Base and LSD-Tartrate and Bioavailability of LSD in Healthy Subjects
Résumé de l'étude
We investigate how single doses of LSD in different formulations differ on a psychological and physical level. The duration between study days is at least 10 days. Neither you nor your doctor knows when you will receive which formulation or placebo (the study is therefore 'double-blind'). The order of the formulation is randomly determined. All subjects receive all formulations, only in a different order. During the study days, we assess the subjective effect on the psyche using various questionnaires. Additionally, we repeatedly measure pulse, blood pressure, and body temperature. To investigate the concentration profile of the substances in the blood, blood samples will be taken from you regularly after the substance administration. Every morning of each study day, an intravenous catheter will be placed in your elbow. Measurements during the substance effect (consisting of blood sampling, blood pressure and pulse measurement, as well as questionnaires) are performed in the first half of the day every fifteen to thirty minutes and in the second half of the day hourly. You have time to read or listen to music between measurements.
(BASEC)
Intervention étudiée
On 4 out of 5 study days, you will receive an equivalent dose of 0.1 mg LSD-Base, once as an alcoholic drinking solution, once as an aqueous drinking solution, once intravenously, and once as a self-dissolving tablet. Additionally, you will receive a placebo on a random study day.
(BASEC)
Maladie en cours d'investigation
Healthy subjects
(BASEC)
- Physically and mentally healthy - Aged between 25 and 65 years - BMI between 18-29 (BASEC)
Critères d'exclusion
- Excessive substance use (including medications, nicotine, and alcohol) - Hypertension - Recent participation in another clinical study (BASEC)
Lieu de l’étude
Bâle
(BASEC)
Sponsor
Prof. Dr. med. Matthias E. Liechti
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Matthias Liechti
061 328 68 68
matthias.liechti@clutterusb.chDepartment of Clinical Pharmacology & Toxicology - University Hospital of Basel
(BASEC)
Informations générales
University Hospital, Basel, Switzerland
(ICTRP)
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
(BASEC)
Date d'approbation du comité d'éthique
11.11.2020
(BASEC)
Identifiant de l'essai ICTRP
NCT04865653 (ICTRP)
Titre officiel (approuvé par le comité d'éthique)
LSD base and LSD tartrate bioequivalence and bioavailability in healthy subjects (BASEC)
Titre académique
LSD Base and LSD Tartrate Bioequivalence and Bioavailability in Healthy Subjects (ICTRP)
Titre public
LSD Base and LSD Tartrate Bioequivalence and Bioavailability in Healthy Subjects (ICTRP)
Maladie en cours d'investigation
Healthy
(ICTRP)
Intervention étudiée
Drug: Lysergic Acid Diethylamide Base oral drinking solution
Drug: Lysergic Acid Diethylamide Base solid orodispersible film
Drug: Lysergic Acid Diethylamide Tartrate intravenous administration
Drug: Lysergic Acid Diethylamide Tartrate oral drinking solution
Other: LSD Placebo
(ICTRP)
Type d'essai
Interventional (ICTRP)
Plan de l'étude
Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Basic Science. Masking: Triple (Participant, Care Provider, Investigator). (ICTRP)
Critères d'inclusion/exclusion
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 (SBP10 cigarettes/day) 10. Consumption of alcoholic beverages (>20 drinks/week)
Minimum age: 25 Years
Maximum age: 65 Years
Sex: All (ICTRP)
non disponible
Critères d'évaluation principaux et secondaires
Bioavailability of LSD base
Bioavailability of LSD tartrate
LSD Cmax
LSD plasma AUC
(ICTRP)
Absence of tolerance
Acute subjective effects I
Acute subjective effects II
Acute subjective effects III
Acute subjective effects IV
Appreciation Scale (AS)
Autonomic effects I
Autonomic effects II
Autonomic effects III
Bioavailability of orodispersible film
Defense Style Questionnaire (DSQ-40)
Freiburger Personality Inventory (FPI-R)
HEXACO personality inventory
NEO-Five-Factor-Inventory (NEO-FFI)
Saarbrücker Personality Questionnaire (SPF)
Subjective well-being I
Subjective well-being II
Subjective well-being III
(ICTRP)
Date d'enregistrement
26.04.2021 (ICTRP)
Inclusion du premier participant
01.06.2021 (ICTRP)
Sponsors secondaires
non disponible
Contacts supplémentaires
Matthias E Liechti, MD, University Hospital, Basel, Switzerland (ICTRP)
ID secondaires
BASEC 2020-02331 (ICTRP)
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
http://www.who.int/trialsearch/Trial2.aspx?TrialID=NCT04865653 (ICTRP)
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible