Effects of LSD on Neuroplasticity in Healthy Subjects

NCT05177419 | Completed Phase 1

• 1 other identifier: LSD-Plasticity
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Neuroplasticity is the brain's ability to reorganize itself and adapt in response to changing environmental conditions or pathological stimuli. LSD is a potent psychedelic drug which has been able to rapidly stimulate neuroplasticity in animal studies. Various authors have speculated that changes in neuroplasticity may contribute to LSD's long-term effects, but there is still little direct evidence that LSD or other psychedelics enhance neuroplasticity in humans. The goal of this study is to investigate the effects of LSD on several measures of neuroplasticity in healthy human subjects.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Change in motor evoked potential amplitude after paired associative stimulation (PAS)

  Assessment of capacity for neuroplastic changes in the motor cortex

  Baseline, 8 hours post-treatment, 1 day post-treatment, 1 week post-treatment

Secondary Outcomes (3)

• Change in auditory event-related potential (ERP) amplitude after tetanic stimulation

  Baseline, 8 hours post-treatment, 1 day post-treatment, 1 week post-treatment

• Plasma and serum levels of brain-derived neurotrophic factor (BDNF)

  Baseline, 8 hours post-treatment, 1 day post-treatment, 1 week post-treatment

• Motor learning ability

  1 day post-treatment

Study Arms (2)

High-dose LSD

EXPERIMENTAL

High dose of lysergic acid diethylamide

Drug: Lysergic Acid Diethylamide

Low-dose LSD

ACTIVE COMPARATOR

Low dose of lysergic acid diethylamide

Drug: Lysergic Acid Diethylamide

Interventions

Lysergic Acid Diethylamide DRUG

100 micrograms LSD base

Also known as: LSD

High-dose LSD

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Aged 21-55
• Body mass index 18-29
• Right-handed as assessed by the Edinburgh Handedness Inventory (score \> 60)
• Fluent understanding of German
• Willingness to adhere to study protocol
• Willingness to refrain from taking illicit psychoactive substances for the duration of the study
• Willingness to refrain from consuming alcohol for 24 hours before each study appointment.
• Willingness to not operate a motor vehicle or other heavy machinery 48 hours after each substance administration.
• Women of childbearing potential must be willing to use effective birth control during the study (e.g. birth control pill; condoms must be combined with a second reliable method).
• Women of childbearing potential must have a negative pregnancy test at the beginning of the study. Pregnancy tests will be repeated before each treatment day and must remain negative.
• A friend or relative must be available to accompany the participant home following LSD appointments.

You may not qualify if:

• Severe chronic or acute medical condition
• History of any seizure disorder, stroke, or cardiovascular illness
• History of severe head trauma resulting in loss of consciousness
• Personal or family history (first-degree relative) of psychotic disorders
• Current or previous major neurological or psychiatric disorder within the last 3 years (e.g. major depression, anorexia, substance use disorder),
• History of medically relevant suicide attempts
• Current use of psychoactive medications
• Lifetime use of hallucinogens, dissociatives, or entheogens more than 10 times, or any time within the previous three months
• Regular (daily or near-daily) use of cannabis, alcohol, nicotine, or illicit substances
• Pregnant or nursing women
• Presence of any implanted, metal or electronic devices (e.g. pacemaker)
• Recent or current participation in another clinical trial

Sponsors & Collaborators

• University of Fribourg: lead

Study Sites (1)

University of Fribourg

Fribourg, Canton of Fribourg, 1752, 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 Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Double-blind, placebo-controlled, cross-over design.

Study Record Dates

• First Submitted: December 15, 2021
• First Posted: January 4, 2022
• Study Start: May 2, 2022
• Primary Completion: March 12, 2025
• Study Completion: March 12, 2025
• Last Updated: April 6, 2025

Record last verified: 2025-04

Locations

CH (1)