Clinical TrialHealthy VolunteersLSDLSDLSDLSDPlaceboCompleted

LSD Base and LSD Tartrate Bioequivalence and Bioavailability in Healthy Subjects

Double-blind, randomised, triple-masked, 5-period crossover study (n=20) comparing 0.1 mg LSD base (oral solution), 0.1 mg LSD base (orodispersible film), 0.146 mg LSD tartrate (oral), 0.146 mg LSD tartrate (IV) and placebo in healthy participants to assess bioequivalence and oral bioavailability.

Target Enrollment
20 participants
Study Type
Phase I interventional
Design
Randomized, triple Blind

Detailed Description

This double-blind, placebo-controlled, five-period crossover study in healthy volunteers compares four formulations of LSD and placebo to assess bioequivalence and determine oral bioavailability.

Treatments include 0.1 mg LSD base in 96% ethanol (oral), 0.1 mg LSD base orodispersible film, 0.146 mg LSD tartrate oral (equivalent to 0.1 mg base), and 0.146 mg LSD tartrate IV; placebo is provided in a quadruple-dummy design.

Outcomes focus on pharmacokinetics to document bioequivalence and estimate oral bioavailability; safety and subjective effects are also monitored.

Study Protocol

Preparation

sessions

Dosing

5 sessions

Integration

sessions

Study Arms & Interventions

LSD base (oral solution)

experimental

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

Interventions

  • LSD0.1 mg
    via Oral• single dose• 1 doses total

    0.1 mg LSD base in 96% ethanol

LSD base (orodispersible)

experimental

Solid orodispersible film containing 0.1 mg LSD base.

Interventions

  • LSD0.1 mg
    via Oral• single dose• 1 doses total

    0.1 mg LSD base orodispersible film

LSD tartrate (oral)

experimental

Oral drinking solution of 0.146 mg LSD tartrate in water (equivalent to 0.1 mg LSD base).

Interventions

  • LSD0.146 mg
    via Oral• single dose• 1 doses total

    0.146 mg LSD tartrate (equivalent to 0.1 mg LSD base)

LSD tartrate (IV)

experimental

Intravenous administration of 0.146 mg LSD tartrate in water (equivalent to 0.1 mg LSD base).

Interventions

  • LSD0.146 mg
    via IV• single dose• 1 doses total

    0.146 mg LSD tartrate IV (equivalent to 0.1 mg LSD base)

Placebo

inactive

Placebo for all formulations (quadruple-dummy).

Interventions

  • Placebo
    via Other• single dose• 1 doses total

    Quadruple-dummy placebo matching each formulation

Participants

Ages
25 – 65
Sexes
Male & Female

Inclusion 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

  • 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)

Study Details

  • Status
    Completed
  • Phase
    Phase I
  • Type
    interventional
  • Design
    Randomizedtriple Blind
  • Target Enrollment20 participants
  • Timeline
    Start: 2021-06-01
    End: 2022-06-30
  • Compounds
    LSDLSDLSDLSDPlacebo
  • Topic
    Healthy Volunteers

Locations

Clinical Pharmacology & Toxicology, University Hospital Basel — Basel, Switzerland

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