Effects of LSD on Neuroplasticity in Healthy Subjects

Healthy Clinical Trial

Official title:

Effects of Lysergic Acid Diethylamide (LSD) on Neuroplasticity in Healthy Human Subjects

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05177419
• Other study ID #: LSD-Plasticity
• Status: Recruiting
• Phase: Phase 1
• Start date: May 2, 2022
• Est. completion date: December 1, 2024

Study information

• Verified date: November 2023
• Source: University of Fribourg
• Contact: Abigail Calder, M.Sc.
• Phone: +41 026 304 26 05
• Email: abigail.calder[@]unifr.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Neuroplasticity is the brain's ability to reorganize itself and adapt in response to changing environmental conditions or pathological stimuli. Its dysregulation may play a role in the etiology of depression and anxiety disorders, and it is also essential for recovery from neural injury and stroke.

LSD is a potent psychedelic drug and a member of the psychoplastogen family of small molecules, which are able to rapidly stimulate neuroplasticity in cortical neurons following a single dose. Previous research suggests that changes in neuroplasticity may contribute to LSD's long-term effects, which include increases in subjective well-being and life satisfaction, reduced anxiety, and increased openness to experience. Additionally, there is some evidence that LSD and other psychedelics could be viable clinical treatments for depression, anxiety, and addictive disorders, and that changes in neuroplasticity may underlie this clinical potential. However, there is still little direct evidence that LSD or other psychoplastogens enhance cortical plasticity in humans.

The goal of this study is to investigate the effects of LSD on several measures of neuroplasticity in healthy human subjects, as well as other abilities and traits thought to be related to neuroplasticity. Determining whether LSD enhances cortical plasticity, how long this may last, where in the brain it occurs, and what it means for cognition and emotion is essential for understanding LSD's long-term effects, including but not limited to its clinical potential.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 55 Years

Eligibility

Inclusion Criteria:

1. Aged 21-55

2. Body mass index 18-29

3. Right-handed as assessed by the Edinburgh Handedness Inventory (score > 60)

4. Fluent understanding of German

5. Willingness to adhere to study protocol

6. Willingness to refrain from taking illicit psychoactive substances for the duration of the study

7. Willingness to refrain from consuming alcohol for 24 hours before each study appointment.

8. Willingness to not operate a motor vehicle or other heavy machinery 48 hours after each substance administration.

9. 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).

10. 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.

11. A friend or relative must be available to accompany the participant home following LSD appointments.

Exclusion Criteria:

1. Severe chronic or acute medical condition

2. History of any seizure disorder, stroke, or cardiovascular illness

3. History of severe head trauma resulting in loss of consciousness

4. Personal or family history (first-degree relative) of psychotic disorders

5. Current or previous major neurological or psychiatric disorder within the last 3 years (e.g. major depression, anorexia, substance use disorder),

6. History of medically relevant suicide attempts

7. Current use of psychoactive medications

8. Lifetime use of hallucinogens, dissociatives, or entheogens more than 10 times, or any time within the previous three months

9. Regular (daily or near-daily) use of cannabis, alcohol, nicotine, or illicit substances

10. Pregnant or nursing women

11. Presence of any implanted, metal or electronic devices (e.g. pacemaker)

12. Recent or current participation in another clinical trial

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Lysergic Acid Diethylamide
100 micrograms LSD base
• Lysergic Acid Diethylamide
Low dose of LSD base

Locations

Country	Name	City	State
Switzerland	University of Fribourg	Fribourg	FR

Sponsors (1)

Lead Sponsor	Collaborator
University of Fribourg

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in auditory event-related potential (ERP) amplitude after tetanic stimulation	Assessment of capacity for neuroplastic changes in the auditory cortex	Baseline, 8 hours post-treatment, 1 day post-treatment, 1 week post-treatment
Secondary	Plasma and serum levels of brain-derived neurotrophic factor (BDNF)	Marker of neuroplasticity	Baseline, 8 hours post-treatment, 1 day post-treatment, 1 week post-treatment
Secondary	Motor learning ability	Speed and accuracy on a motor learning task	1 day post-treatment