LSD Base and LSD Tartrate Bioequivalence and Bioavailability in Healthy Subjects

NCT04865653 | Completed Phase 1

• 1 other identifier: BASEC 2020-02331
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• LSD plasma AUC

  Assessed 22 times on each study day via blood samples

  18 months

• LSD Cmax

  Assessed 22 times on each study day via blood samples

  18 months

• Bioavailability of LSD base

  Assessed 22 times on each study day via blood samples

  18 months

• Bioavailability of LSD tartrate

  Assessed 22 times on each study day via blood samples

  18 months

Secondary Outcomes (18)

• Acute subjective effects I

  18 months

• Acute subjective effects II

  18 months

• Acute subjective effects III

  18 months

• Acute subjective effects IV

  18 months

• Autonomic effects I

  18 months

Study Arms (5)

Oral drinking solution of LSD base

EXPERIMENTAL

Oral drinking solution of 0.1 mg LSD base in 96% ethanol

Drug: Lysergic Acid Diethylamide Base oral drinking solution

Solid orodispersible film containing LSD base

EXPERIMENTAL

Solid orodispersible film containing 0.1 mg LSD base

Drug: Lysergic Acid Diethylamide Base solid orodispersible film

Oral drinking solution of LSD tartrate

EXPERIMENTAL

Oral drinking solution of 0.146 mg LSD tartrate in water

Drug: Lysergic Acid Diethylamide Tartrate oral drinking solution

Intravenous administration of LSD tartrate

EXPERIMENTAL

Intravenous administration of 0.146 mg LSD tartrate in water

Drug: Lysergic Acid Diethylamide Tartrate intravenous administration

Placebo

PLACEBO COMPARATOR

Placebo for all formulations

Other: LSD Placebo

Interventions

Lysergic Acid Diethylamide Base oral drinking solution DRUG

A moderate dose of 0.1 mg LSD will be administered.

Also known as: LSD

Oral drinking solution of LSD base

Lysergic Acid Diethylamide Base solid orodispersible film DRUG

A moderate dose of 0.1 mg LSD will be administered.

Also known as: LSD

Solid orodispersible film containing LSD base

Lysergic Acid Diethylamide Tartrate oral drinking solution DRUG

A moderate dose of 0.146 mg LSD tartrate will be administered (equivalent to 0.1 mg LSD base).

Also known as: LSD

Oral drinking solution of LSD tartrate

Lysergic Acid Diethylamide Tartrate intravenous administration DRUG

A moderate dose of 0.146 mg LSD tartrate will be administered (equivalent to 0.1 mg LSD base).

Also known as: LSD

Intravenous administration of LSD tartrate

LSD Placebo OTHER

Placebo for each formulation containing only the solvent or gel but no LSD.

Also known as: Placebo

Placebo

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

Clinical Pharmacology & Toxicology, University Hospital Basel

Basel, 4031, Switzerland

Location

MeSH Terms

Interventions

Lysergic Acid Diethylamide

Intervention Hierarchy (Ancestors)

Lysergic Acid; Ergolines; Ergot Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring

Study Officials

• Matthias E Liechti, MD

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double-blind, placebo-controlled, 5-period cross-over design with five treatment conditions: 1. Oral drinking solution of 0.1 mg LSD base in 96% ethanol 2. Solid orodispersible film containing 0.1 mg LSD base 3. Oral drinking solution of 0.146 mg LSD tartrate in water (equivalent to 0.1 mg LSD base) 4. Intravenous administration of 0.146 mg LSD tartrate in water (equivalent to 0.1 mg LSD base) 5. Placebo

Study Record Dates

• First Submitted: April 26, 2021
• First Posted: April 29, 2021
• Study Start: March 17, 2022
• Primary Completion: October 11, 2023
• Study Completion: October 11, 2023
• Last Updated: February 14, 2024

Record last verified: 2024-02

Locations

CH (1)