Comparison of LSD-Base and LSD-Tartrate and Bioavailability of LSD in Healthy Subjects
Zusammenfassung der Studie
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)
Untersuchte Intervention
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)
Untersuchte Krankheit(en)
Healthy subjects
(BASEC)
- Physically and mentally healthy - Aged between 25 and 65 years - BMI between 18-29 (BASEC)
Ausschlusskriterien
- Excessive substance use (including medications, nicotine, and alcohol) - Hypertension - Recent participation in another clinical study (BASEC)
Studienstandort
Basel
(BASEC)
Sponsor
Prof. Dr. med. Matthias E. Liechti
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Matthias Liechti
061 328 68 68
matthias.liechti@clutterusb.chDepartment of Clinical Pharmacology & Toxicology - University Hospital of Basel
(BASEC)
Allgemeine Auskünfte
University Hospital, Basel, Switzerland
(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
(BASEC)
Datum der Bewilligung durch die Ethikkommission
11.11.2020
(BASEC)
ICTRP Studien-ID
NCT04865653 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
LSD base and LSD tartrate bioequivalence and bioavailability in healthy subjects (BASEC)
Wissenschaftlicher Titel
LSD Base and LSD Tartrate Bioequivalence and Bioavailability in Healthy Subjects (ICTRP)
Öffentlicher Titel
LSD Base and LSD Tartrate Bioequivalence and Bioavailability in Healthy Subjects (ICTRP)
Untersuchte Krankheit(en)
Healthy
(ICTRP)
Untersuchte Intervention
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)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Basic Science. Masking: Triple (Participant, Care Provider, Investigator). (ICTRP)
Ein-/Ausschlusskriterien
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)
nicht verfügbar
Primäre und sekundäre Endpunkte
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)
Registrierungsdatum
26.04.2021 (ICTRP)
Einschluss des ersten Teilnehmers
01.06.2021 (ICTRP)
Sekundäre Sponsoren
nicht verfügbar
Weitere Kontakte
Matthias E Liechti, MD, University Hospital, Basel, Switzerland (ICTRP)
Sekundäre IDs
BASEC 2020-02331 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
http://www.who.int/trialsearch/Trial2.aspx?TrialID=NCT04865653 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar