Comparison of LSD-Base and LSD-Tartrate and Bioavailability of LSD in Healthy Subjects
Summary description of the study
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 under investigation
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)
Disease under investigation
Healthy subjects
(BASEC)
- Physically and mentally healthy - Aged between 25 and 65 years - BMI between 18-29 (BASEC)
Exclusion criteria
- Excessive substance use (including medications, nicotine, and alcohol) - Hypertension - Recent participation in another clinical study (BASEC)
Trial sites
Basel
(BASEC)
Sponsor
Prof. Dr. med. Matthias E. Liechti
(BASEC)
Contact
Contact Person Switzerland
Matthias Liechti
061 328 68 68
matthias.liechti@clutterusb.chDepartment of Clinical Pharmacology & Toxicology - University Hospital of Basel
(BASEC)
General Information
University Hospital, Basel, Switzerland
(ICTRP)
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee northwest/central Switzerland EKNZ
(BASEC)
Date of authorisation
11.11.2020
(BASEC)
ICTRP Trial ID
NCT04865653 (ICTRP)
Official title (approved by ethics committee)
LSD base and LSD tartrate bioequivalence and bioavailability in healthy subjects (BASEC)
Academic title
LSD Base and LSD Tartrate Bioequivalence and Bioavailability in Healthy Subjects (ICTRP)
Public title
LSD Base and LSD Tartrate Bioequivalence and Bioavailability in Healthy Subjects (ICTRP)
Disease under investigation
Healthy
(ICTRP)
Intervention under investigation
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 of trial
Interventional (ICTRP)
Trial design
Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Basic Science. Masking: Triple (Participant, Care Provider, Investigator). (ICTRP)
Inclusion/Exclusion criteria
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)
not available
Primary and secondary end points
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)
Registration date
26.04.2021 (ICTRP)
Incorporation of the first participant
01.06.2021 (ICTRP)
Secondary sponsors
not available
Additional contacts
Matthias E Liechti, MD, University Hospital, Basel, Switzerland (ICTRP)
Secondary trial IDs
BASEC 2020-02331 (ICTRP)
Results-Individual Participant Data (IPD)
not available
Further information on the trial
http://www.who.int/trialsearch/Trial2.aspx?TrialID=NCT04865653 (ICTRP)
Results of the trial
Results summary
not available
Link to the results in the primary register
not available