HealthyPhase 1NCT05177419
Effects of LSD on Neuroplasticity in Healthy Subjects
A Phase 1 study testing Lysergic Acid Diethylamide in people with Healthy, run by University of Fribourg at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Lysergic Acid Diethylamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteSwitzerland
- Study dates
- 2 May 2022to 12 Mar 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University of Fribourg
Fribourg, Canton of Fribourg, 1752
About this study
Official title: Effects of Lysergic Acid Diethylamide (LSD) on Neuroplasticity in Healthy Human Subjects
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Lysergic Acid Diethylamide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lysergic Acid DiethylamideDrug
Also called LSD
100 micrograms LSD base
Lysergic Acid DiethylamideDrug
Also called LSD
Low dose of LSD base
| Study group | Role | What they receive |
|---|---|---|
| High-dose LSD | Experimental | High dose of lysergic acid diethylamide Receives: Drug: Lysergic Acid Diethylamide |
| Low-dose LSD | Active comparator | Low dose of lysergic acid diethylamide Receives: Drug: Lysergic Acid Diethylamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in motor evoked potential amplitude after paired associative stimulation (PAS)
Assessment of capacity for neuroplastic changes in the motor cortex
Measured: 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
Assessment of capacity for neuroplastic changes in the auditory cortex
Measured: Baseline, 8 hours post-treatment, 1 day post-treatment, 1 week post-treatment
Plasma and serum levels of brain-derived neurotrophic factor (BDNF)
Marker of neuroplasticity
Measured: Baseline, 8 hours post-treatment, 1 day post-treatment, 1 week post-treatment
Motor learning ability
Speed and accuracy on a motor learning task
Measured: 1 day post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2022
- Study start2 May 2022
- Primary completion12 Mar 2025
- Study completion12 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Double-blind, placebo-controlled, cross-over design.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Fribourg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gregor Hasler, University of Fribourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05177419
- Sponsor's protocol ID
- LSD-Plasticity
- Status last verified
- Apr 2025
- First submitted
- 15 Dec 2021
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Lysergic Acid Diethylamide (LSD) on Neuroplasticity in Healthy Human Subjects
- ClinicalTrials.gov ID
- NCT05177419
- Acronym / sponsor ID
- LSD-Plasticity
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of FribourgUniversity, hospital or other
- Study start
- 2 May 2022 (actual)
- Primary completion
- 12 Mar 2025 (actual)
- Study completion
- 12 Mar 2025 (actual)
- First posted
- 4 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blind, placebo-controlled, cross-over design.
| Arm | Type | Receives |
|---|---|---|
| High-dose LSD | Experimental | Drug: Lysergic Acid DiethylamideHigh dose of lysergic acid diethylamide |
| Low-dose LSD | Active comparator | Drug: Lysergic Acid DiethylamideLow dose of lysergic acid diethylamide |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (12 listed)
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lysergic Acid DiethylamideAlso: LSD100 micrograms LSD base | Drug | High-dose LSD |
| Lysergic Acid DiethylamideAlso: LSDLow dose of LSD base | Drug | Low-dose LSD |
Primary outcome
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
3 secondary outcomes
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
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
Motor learning ability
Time frame: 1 day post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lysergic Acid Diethylamide in people with Healthy, run by University of Fribourg at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2025.