LSD Base and LSD Tartrate Bioequivalence and Bioavailability in Healthy Subjects (LSD-Bio)

  • STATUS
    Recruiting
  • days left to enroll
    55
  • participants needed
    20
  • sponsor
    University Hospital, Basel, Switzerland
Updated on 23 April 2022
Accepts healthy volunteers

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.

Description

LSD is widely used for recreational and spiritual purposes. Additionally LSD is currently reused in experimental studies with healthy subjects and in studies investigating its effects on patients suffering from anxiety, depression, addiction personality disorders, cluster headache, migraine, and other pathological conditions.

When LSD is used recreationally, it is administered mostly in the form of LSD tartrate on filter paper (blotter) or as a liquid. In experimental research over the past years, LSD has mostly been used in the form of LSD base, which is lipophilic and therefore has typically been administered as a solution in ethanol. However, some researchers have also use LSD tartrate orally or LSD base intravenously. Currently, it is not clear how these different forms of LSD compare regarding their bioequivalence and effects.

The present study therefore compares four different formulations of LSD and placebo: (1) An oral drinking solution of LSD base currently used in many research studies (100 μg LSD in 96% ethanol), (2) A solid orodispersible film containing LSD base (100 μg LSD), (3) LSD tartrate used in research and recreationally (100 μg LSD equivalent of LSD tartrate in water), (4) an intravenous administration of LSD tartrate (100 μg LSD equivalent of LSD tartrate in water), and (5) placebo for all formulations (quadruple-dummy). The primary goals are to document the bioequivalence of LSD base (1) and tartrate (3) and to define the oral bioavailability of LSD using an additional intravenous LSD administration.

Details
Condition Healthy
Treatment LSD Placebo, Lysergic Acid Diethylamide Base oral drinking solution, Lysergic Acid Diethylamide Base solid orodispersible film, Lysergic Acid Diethylamide Tartrate oral drinking solution, Lysergic Acid Diethylamide Tartrate intravenous administration
Clinical Study IdentifierNCT04865653
SponsorUniversity Hospital, Basel, Switzerland
Last Modified on23 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age between 25 and 65 years old
Sufficient understanding of the German language
Understanding of procedures and risks associated with the study
Willing to adhere to the protocol and signing of the consent form
Willing to refrain from the consumption of illicit psychoactive substances during the study
Abstaining from xanthine-based liquids from the evenings prior to the study sessions to the end of the study days
Willing not to operate heavy machinery within 48 hours after substance administration
Willing to use double-barrier birth control throughout study participation
Body mass index between 18-29 kg/m2

Exclusion Criteria

Chronic or acute medical condition
Current or previous major psychiatric disorder
Psychotic disorder or bipolar disorder in first-degree relatives
Hypertension (>140/90 mmHg) or hypotension (SBP<85 mmHg)
Hallucinogenic substance use (not including cannabis) more than 20 times or any time within the previous two months
Pregnancy or current breastfeeding
Participation in another clinical trial (currently or within the last 30 days)
Use of medication that may interfere with the effects of the study medication
Tobacco smoking (>10 cigarettes/day)
Consumption of alcoholic beverages (>20 drinks/week)
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