This study was a Phase 1, double-blind, placebo-controlled, randomised study of very low dose LSD. Healthy volunteers aged 55 to 75 years with no use of LSD in the past 5 years were screened within 28 days of randomization. Subjects who met all inclusion and no exclusion criteria and provided written informed consent were randomised a 1:1:1:1 ratio to receive 6 doses of 5 µg, 10 µg, or 20 µg LSD or placebo, at 4-day intervals for 21 days (on Study Days 1, 5, 9, 13, 17, and 21). A follow-up visit was conducted approximately 4 weeks after the last dose of LSD. A total of 48 subjects were enrolled.
The magnitude of the effect of LSD was explored across specific PD measures. These included: * Cognition and affect, including evaluation of memory, temporal perception, executive function, and learning * Subjective effects * Proprioception and balance
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
48
To evaluate the safety and tolerability of very low dose LSD
Assessment of Adverse Events by % frequency
Time frame: 2.5 weeks
To evaluate the pharmacokinetics of very low dose LSD - Variation of plasma concentration over time
AUC 0-12h ( pg/mL\*h): area under the plasma concentration-time curve profiles from time zero to the 12 hour sample determined using the linear trapezoidal rule.
Time frame: 12 hours
To evaluate the pharmacokinetics of very low dose LSD - Maximum Peak concentration of drug
Cmax (pg/mL): maximum drug plasma concentration
Time frame: 12 hours
To evaluate the pharmacokinetics of very low dose LSD - Half life of drug
Tmax (h): time to reach maximum plasma concentration Tlag (h): time for drug to appear in plasma
Time frame: 12 hours
To evaluate the pharmacodynamic (PD) and cumulative effect of very low dose LSD on cognition.
The CANTAB (Cambridge Neuropsychological Test Automated Battery ) included four test that measured cognitive function. These were Reaction Time (RTI) for reaction times, Paired Associates Learning (PAL) for visual memory and learning, Rapid Visual Information Processing (RVP) for sustained memory, Spatial Working Memory (SWM) for retention of visuospatial information.
Time frame: 2.5 weeks
To evaluate the pharmacodynamic (PD) and cumulative effect of very low dose LSD on Acute subjective effects.
Assessed by the Visual Analog Scale (VAS). Items assess acute subjective drug effects (e.g. intensity, liking) Item scores are assessed on a visual scale ranging from 1% to 100%. Higher scores indicate greater subjective effects
Time frame: 2.5 weeks
To evaluate the pharmacodynamic (PD) and cumulative effect of very low dose LSD on the characteristics of altered states of consciousness assessed by questionnaire
5-Dimensional Altered States of Consciousness Questionnaire (5D-ASC). The scale ranges from no, not more than usual (on the left) to yes, very much more than usual (on the right). Items retrospectively assess subjective drug effects. Item scores are assessed on a visual scale ranging from 1% to 100%. Higher scores indicate greater subjective effects associated with a different state of consciousness
Time frame: 2.5 weeks
To evaluate the pharmacodynamic (PD) and cumulative effect of very low dose LSD on Balance tracking
Static balance as assessed by center of pressure (COP) using a portable force plate (Balance Tracking Systems, BTrackS™)
Time frame: 2.5 weeks
To evaluate the pharmacodynamic (PD) and cumulative effect of very low dose LSD on Proprioception
The ability to sense stimuli arising within the body regarding position and motion will be measured in 15 trials during which the participant will have their arm rotated to set angles and asked to reproduce the angle while blindfolded. Performance is measured as the absolute error between the target and matching angle.
Time frame: 2.5 weeks
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