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.
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.
Oral drinking solution of 0.1 mg LSD base in 96% ethanol.
0.1 mg LSD base in 96% ethanol
Solid orodispersible film containing 0.1 mg LSD base.
0.1 mg LSD base orodispersible film
Oral drinking solution of 0.146 mg LSD tartrate in water (equivalent to 0.1 mg LSD base).
0.146 mg LSD tartrate (equivalent to 0.1 mg LSD base)
Intravenous administration of 0.146 mg LSD tartrate in water (equivalent to 0.1 mg LSD base).
0.146 mg LSD tartrate IV (equivalent to 0.1 mg LSD base)
Placebo for all formulations (quadruple-dummy).
Quadruple-dummy placebo matching each formulation