CompletedPhase 1

LSD Base and LSD Tartrate Bioequivalence and Bioavailability in Healthy Subjects

NCT04865653 · LSD-Bio · University Hospital, Basel, Switzerland

Closed to entry

Status

Not accepting participants

Phase 1

Phase

Target enrolment

Study sites

Outside the US

What it is testing

Summary

Lysergic acid diethylamide (LSD) is used as recreational substance and as a research substance to study the mind. Recreationally, LSD is typically used in the form of "blotters" containing LSD tartrate. In research, both LSD base (LSD alone) or LSD salt in the form of LSD tartrate are used. The oral bioavailability of LSD is not known and LSD alone and LSD as salt have never been directly compared regarding their equivalence of plasma concentrations and effects. Because different forms of LSD are used in research it is important to know their difference or equivalence for correct dosing of LSD. The present study will compare equivalent doses of LSD base in ethanol orally, LSD tartrate in water administered orally, LSD base in an orodispersible film administered orally and LSD tartrate in water administered intravenously, as well as a placebo using a double-blind, randomized, counterballanced cross-over design in healthy participants.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

LSD plasma AUC
Measured over 18 months
LSD Cmax
Measured over 18 months
Bioavailability of LSD base
Measured over 18 months
Bioavailability of LSD tartrate
Measured over 18 months

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

25 Years to 65 Years

Ages

All

Sex

Accepted

Healthy volunteers

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 (SBP\<85 mmHg) 5. Hallucinogenic substance use (not including cannabis) more than 20 times or any time within the previous two months 6. Pregnancy or current breastfeeding 7. Participation in another clinical trial (currently or within the last 30 days) 8. Use of medication that may interfere with the effects of the study medication 9. Tobacco smoking (\>10 cigarettes/day) 10. Consumption of alcoholic beverages (\>20 drinks/week)

Where

1 study site

Facility	City	Region	Country
Clinical Pharmacology & Toxicology, University Hospital Basel	Basel	—	Switzerland

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

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NCT04865653 on ClinicalTrials.gov →

Last updated in the registry 2024-02-14. Registry records change; this page reflects the data build of 2026-08-25.

Where this trial sits

Substance

All 48 trials from University Hospital, Basel, Switzerland →