Effects of LSD on Neuroplasticity in Healthy Subjects
Effects of Lysergic Acid Diethylamide (LSD) on Neuroplasticity in Healthy Human Subjects
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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FR
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Fribourg, FR, Switzerland, 1752
- University of Fribourg
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: High-dose LSD
High dose of lysergic acid diethylamide
|
100 micrograms LSD base
Other Names:
Low dose of LSD base
Other Names:
|
|
Active Comparator: Low-dose LSD
Low dose of lysergic acid diethylamide
|
100 micrograms LSD base
Other Names:
Low dose of LSD base
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in motor evoked potential amplitude after paired associative stimulation (PAS)
Time Frame: Baseline, 8 hours post-treatment, 1 day post-treatment, 1 week post-treatment
|
Assessment of capacity for neuroplastic changes in the motor cortex
|
Baseline, 8 hours post-treatment, 1 day post-treatment, 1 week post-treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in auditory event-related potential (ERP) amplitude after tetanic stimulation
Time Frame: Baseline, 8 hours post-treatment, 1 day post-treatment, 1 week post-treatment
|
Assessment of capacity for neuroplastic changes in the auditory cortex
|
Baseline, 8 hours post-treatment, 1 day post-treatment, 1 week post-treatment
|
|
Plasma and serum levels of brain-derived neurotrophic factor (BDNF)
Time Frame: Baseline, 8 hours post-treatment, 1 day post-treatment, 1 week post-treatment
|
Marker of neuroplasticity
|
Baseline, 8 hours post-treatment, 1 day post-treatment, 1 week post-treatment
|
|
Motor learning ability
Time Frame: 1 day post-treatment
|
Speed and accuracy on a motor learning task
|
1 day post-treatment
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LSD-Plasticity
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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