HealthyPhase 1NCT05674669
A Dose-Ranging Study of 50 µg to 100 µg LSD in Healthy Volunteers
A Phase 1 study testing Lysergic Acid Diethylamide (LSD) 50µg, Lysergic Acid Diethylamide (LSD) 75µg and Lysergic Acid Diethylamide (LSD) 100µg in people with Healthy, run by Eleusis Therapeutics at 1 site in United Kingdom.
Trial summary
This study with low-dose LSD comprised 2 substudies in healthy subjects. Subjects who met all inclusion and no exclusion criteria provided written informed consent. Part 1 was an open-label dose-escalation study in hallucinogen non-naïve subjects with significant prior experience with hallucinogens, during which each… Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Lysergic Acid Diethylamide (LSD) 50µg, Lysergic Acid Diethylamide (LSD) 75µg and Lysergic Acid Diethylamide (LSD) 100µg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Oct 2015to 17 Jul 2017
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male or female subject aged 21 to 65 years inclusive.
- For Part 1, subject has been previously exposed to LSD or any other classic psychedelic drug, including psilocybin, mescaline, and ayahuasca, on more than 3 occasions during their lifetime. For Part 2, Subject has not been previously exposed to LSD or any other classic psychedelic drug, including psilocybin, mescaline, and ayahuasca, during the past 7 years.
- Subject was able and willing to give written informed consent, adhere to the compliance terms during participation in the study, undergo the examinations and testing set forth in the clinical study protocol, and clearly and reliably communicate their subjective experiences to the investigator.
- Female participants of childbearing potential and male participants whose partner was of childbearing potential must have been willing to ensure that they or their partner used effective contraception during the study and for 3 months after the final study drug administration.
Who cannot join
- General Health
- Subject had a presence or clinically relevant history of any psychiatric, respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, musculoskeletal, genitourinary, immunological, dermatological, connective tissue diseases or disorders, as judged by the investigator.
- Subject had a resting blood pressure exceeding 140 mmHg (systolic) or 90 mmHg (diastolic), averaged across 4 assessments taken at least 1 minute apart on the same day.
- Subject had a presence or relevant history of organic brain disorders (e.g., intracranial hypertension, aneurisms, impaired consciousness, lethargy, or brain tumour).
- Subject had a relevant history of atopy, hypersensitivity, skin allergies, or allergic reactions to drugs.
- Subject had a clinical laboratory test result outside the reference ranges of the testing laboratory and considered clinically significant by the investigator.
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- Subject was positive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency (HIV) virus I or II at screening.
- Subject was a current smoker (i.e., had smoked within 1 month prior to the screening visit).
- Subject had a medical history that would affect the subject's safety or the study endpoints.
- Subject had used prescription drugs which might potentially interact with the pharmacokinetics of LSD or therapy within 14 days of first dosing, unless agreed as not clinically relevant by the PI and the Medical Monitor.
- Subject had used over the counter (OTC) medication or therapy, including megadose vitamin therapy (but excluding routine vitamins) within 7 days of first dosing, unless agreed as not clinically relevant by the PI and the Medical Monitor.
- Subject had donated or received any blood or blood products within the previous 3 months prior to first dosing.
- Subject could not use a computer to complete simple tasks such as responding to an email.
- Subject had used any investigational drug or participated in any clinical trial within 3 months of their first dosing.
- Subject had a current sleep disorder.
- Subject had a history of cataracts, active glaucoma or any other ophthalmic condition that could interfere with the eye blink assessment.
- Subject had veins unsuitable for venepuncture and/or cannulation.
- Subject had a corrected QT interval using Fridericia's correction >450 milliseconds.
- Subject was unlikely to cooperate with the requirements of the study, in the opinion of the PI or designee.
- Subject was pregnant or lactating
- Exclusion Part 2 only: Subject had a history of drug abuse or dependence in the last 12 months, had current drug abuse or dependence or had a positive result for drugs of abuse and alcohol tests at screening or admission.
- Psychiatric Health
- Subject had a current or past history of meeting Diagnostic and Statistical Manual of Mental Disorders fourth edition criteria for schizophrenia or other psychotic disorders (unless substance induced or due to a medical condition), bipolar I or II disorder, a major depressive episode, a manic or hypomanic episode, alcohol dependence or abuse (in the past 5 years), substance dependence and abuse (in the past 5 years), current panic disorder, obsessive compulsive disorder, social anxiety disorder, generalised anxiety disorder, anorexia, bulimia or post-traumatic stress disorder
- Subject had a first- or second-degree relative with schizophrenia, other psychotic disorders (unless substance-induced or due to a medical condition), or bipolar I or II disorder.
- Subject was receiving chronic administration of tricyclic antidepressants or lithium or acute administration of serotonin reuptake inhibitors, haloperidol, serotonin reuptake inhibitors or monoamine oxidase inhibitors.
- Subject was taking OTC doses of 5-hydroxytryptophan or St John's Wort or ayahuasca (which contains monoamine oxidase inhibitors in addition to dimethyltryptamine).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Single-centre, Dose-escalation Study Utilising Both Open-label and Double-blind Placebo-controlled Crossover Design Studies to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Low Doses of Lysergic Acid Diethylamide Ranging From 50 µg to 100 µg in Healthy Volunteers
This study with low-dose LSD comprised 2 substudies in healthy subjects. Subjects who met all inclusion and no exclusion criteria provided written informed consent. Part 1 was an open-label dose-escalation study in hallucinogen non-naïve subjects with significant prior experience with hallucinogens, during which each subject received a single dose of LSD: 50, 75, or 100 µg. Part 2 was a double blind, placebo controlled, randomised, crossover study in hallucinogen naïve subjects with no prior experience with hallucinogens in the last 7 years, during which each subject was assigned to 1 of 8 cohorts and then randomly assigned to receive single doses of LSD 50 µg followed by 75 µg, or placebo followed by 75 µg, with dosing separated by at least 7 days. Subjects were followed up on the day after each dosing, and 1 week and 1 month after the last dose of study treatment. A total of 32 subjects were enrolled.
Read the detailed description
This study with low-dose LSD comprised 2 substudies in different populations of healthy subjects:
Part 1: an open-label dose-escalation study in hallucinogen non-naïve subjects. Part 2: a double blind, placebo controlled, randomised, crossover study in hallucinogen naïve subjects.
Part 1: Open-label, dose escalation study This part was performed in a population of healthy subjects with significant prior experience with hallucinogens. There was a screening period of up to 28 days. Following provision of informed consent and completion of all screening assessments, eligible subjects were assigned to the open-label dose-escalation group.
Following completion of baseline assessments, each subject received a single dose of LSD: 50, 75, or 100 µg. This dose range was selected for assessment based on extensive historical and clinical LSD research. Subjects knew they would receive the experimental drug but were blinded to the dose level received. Subjects were followed up on the day after dosing and at 1 week and 1 month after dosing.
During screening, baseline, treatment, and follow-up, subjects underwent a series of assessments. Included amongst these assessments were cognitive tasks that were administered at baseline before administration of LSD and subsequently during the study. The open-label study subjects also provided samples for PK analysis.
Part 2: Double-blind, placebo controlled, randomised, crossover study This part commenced following evaluation of the results from Part 1. It was performed in a population of healthy subjects with no prior experience with hallucinogens during the last 7 years. There was a screening period of up to 28 days. Following provision of informed consent and completion of all screening assessments, eligible subjects were assigned to 1 of 8 cohorts and then randomly assigned to 1 of 2 treatment groups. Cognitive assessments were administered at baseline before administration of the first dose and subsequently during the study.
Following completion of baseline assessments, subjects entered a 2 week treatment period: the experimental non-crossover group received 2 sequential escalating single doses of LSD administered at levels determined in Part 1 (50 µg followed by 75 µg, or placebo followed by 75 µg), with dosing separated by at least 7 days; the placebo controlled crossover group received placebo followed at least 7 days later by a single dose of 75 µg LSD, as determined in Part 1. Subjects were followed up on the day after each dosing, 1 week after the second dose, and at 1 month after the last dose of study treatment.
During screening, baseline, treatment and follow-up days, subjects underwent a series of assessments.
- Conditions
- Healthy
- Being tested
- Lysergic Acid Diethylamide (LSD) 50µg, Lysergic Acid Diethylamide (LSD) 75µg, Lysergic Acid Diethylamide (LSD) 100µg, Placebo/Lysergic Acid Diethylamide (LSD) 75µg, Lysergic Acid Diethylamide (LSD) 50µg/75µg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lysergic Acid Diethylamide (LSD) 50µgDrug
Lysergic Acid Diethylamide (LSD) 75µgDrug
Lysergic Acid Diethylamide (LSD) 100µgDrug
Placebo/Lysergic Acid Diethylamide (LSD) 75µgDrug
Lysergic Acid Diethylamide (LSD) 50µg/75µgDrug
| Study group | Role | What they receive |
|---|---|---|
| Group 1 N=3 | Experimental | Single dose, follow-up visits at one day, one week, and one month after dose. Receives: Drug: Lysergic Acid Diethylamide (LSD) 50µg |
| Group 2 N=7 | Experimental | Single dose, follow-up visits at one day, one week, and one month after dose. Receives: Drug: Lysergic Acid Diethylamide (LSD) 75µg |
| Group 3 N=3 | Experimental | Single dose, follow-up visits at one day, one week, and one month after dose. Receives: Drug: Lysergic Acid Diethylamide (LSD) 100µg |
| Group 4 N=10 | Experimental | Randomized treatment with placebo followed by single dose, separated by 7 days. Follow-up visits at one day, one week, and one month after last dose. Receives: Drug: Placebo/Lysergic Acid Diethylamide (LSD) 75µg |
| Group 5 N=9 | Experimental | Randomized treatment with single dose followed by second dose, separated by 7 days. Follow-up visits at one day, one week, and one month after last dose. Receives: Drug: Lysergic Acid Diethylamide (LSD) 50µg/75µg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Adverse Events by % frequency
Assessment of Adverse Events by % frequency to assess the safety and tolerability of LSD
Measured: 1 year
AUC 0-24h ( pg/mL*h) over time
AUC 0-24h ( pg/mL*h): area under the plasma concentration-time curve profiles from time zero to the 24 hour sample determined using the linear trapezoidal rule
Measured: 24 hours
Cmax (pg/mL)drug
Cmax (pg/mL): maximum drug plasma concentration
Measured: 24 hours
Tmax (h)
Tmax (h): time to reach maximum plasma concentration, T1/2 (h): time to reach half of maximum drug plasma concentration
Measured: 24 hours
Secondary outcomes (4)
Assess subjective drug effects using a VAS.
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
Measured: 12 hours
Assess subjective drug effects on the 5D-ASC
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
Measured: 12 hours
Assess ego dissolution by the EDI
The EDI is an eight-item questionnaire designed to measure ego dissolution. Each item is scored on a 5-point Likert-type scale, and the inventory includes a single factor. Higher scores indicate greater subjective effects associated with a different state of consciousness
Measured: 12 hours
Assess the characteristics of altered states of consciousness assessed by the MEQ
The MEQ is a 30-item self-report questionnaire developed for detecting and characterizing mystical experiences induced by classic psychedelics. Each item is scored on a 5-point Likert-type scale, and derived scores for the MEQ include four scales: mystical, positive mood, transcendence of time and space, and ineffability. In addition, a response of more than or equal to 60% of each and every scale would classify an experience as a 'complete mystical experience'. Higher scores indicate greater subjective effects associated with a different state of consciousness.
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2023
- Study start20 Oct 2015
- Primary completion26 Jul 2016
- Study completion17 Jul 2017
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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- In Part 1, each subject was allocated to open label treatment with a single dose of 50 µg, 75 µg, or 100 µg LSD. Part 1 was conducted in hallucinogen non-naive participants. In Part 2, each subject was randomized to double blind treatment and received 50 µg LSD followed by 75 µg LSD (experimental non-crossover group), or placebo followed by 75 µg LSD (placebo-controlled crossover group), with dosing separated by at least 7 days. Part 2 was conducted in hallucinogen naive participants.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eleusis Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Director of Research and Development, Study director, Eleusis Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05674669
- Sponsor's protocol ID
- CAS-50-37-3-02
- Other IDs
- 2015-003151-21, 2015
- Status last verified
- Jan 2023
- First submitted
- 27 Jul 2022
- Last updated
- 6 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single-centre, Dose-escalation Study Utilising Both Open-label and Double-blind Placebo-controlled Crossover Design Studies to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Low Doses of Lysergic Acid Diethylamide Ranging From 50 µg to 100 µg in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05674669
- Acronym / sponsor ID
- CAS-50-37-3-02
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Eleusis TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 20 Oct 2015 (actual)
- Primary completion
- 26 Jul 2016 (actual)
- Study completion
- 17 Jul 2017 (actual)
- First posted
- 6 Jan 2023 (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.
This study with low-dose LSD comprised 2 substudies in healthy subjects. Subjects who met all inclusion and no exclusion criteria provided written informed consent. Part 1 was an open-label dose-escalation study in hallucinogen non-naïve subjects with significant prior experience with hallucinogens, during which each subject received a single dose of LSD: 50, 75, or 100 µg. Part 2 was a double blind, placebo controlled, randomised, crossover study in hallucinogen naïve subjects with no prior experience with hallucinogens in the last 7 years, during which each subject was assigned to 1 of 8 cohorts and then randomly assigned to receive single doses of LSD 50 µg followed by 75 µg, or placebo followed by 75 µg, with dosing separated by at least 7 days. Subjects were followed up on the day after each dosing, and 1 week and 1 month after the last dose of study treatment. A total of 32 subjects were enrolled.
Detailed description
This study with low-dose LSD comprised 2 substudies in different populations of healthy subjects:
Part 1: an open-label dose-escalation study in hallucinogen non-naïve subjects. Part 2: a double blind, placebo controlled, randomised, crossover study in hallucinogen naïve subjects.
Part 1: Open-label, dose escalation study This part was performed in a population of healthy subjects with significant prior experience with hallucinogens. There was a screening period of up to 28 days. Following provision of informed consent and completion of all screening assessments, eligible subjects were assigned to the open-label dose-escalation group.
Following completion of baseline assessments, each subject received a single dose of LSD: 50, 75, or 100 µg. This dose range was selected for assessment based on extensive historical and clinical LSD research. Subjects knew they would receive the experimental drug but were blinded to the dose level received. Subjects were followed up on the day after dosing and at 1 week and 1 month after dosing.
During screening, baseline, treatment, and follow-up, subjects underwent a series of assessments. Included amongst these assessments were cognitive tasks that were administered at baseline before administration of LSD and subsequently during the study. The open-label study subjects also provided samples for PK analysis.
Part 2: Double-blind, placebo controlled, randomised, crossover study This part commenced following evaluation of the results from Part 1. It was performed in a population of healthy subjects with no prior experience with hallucinogens during the last 7 years. There was a screening period of up to 28 days. Following provision of informed consent and completion of all screening assessments, eligible subjects were assigned to 1 of 8 cohorts and then randomly assigned to 1 of 2 treatment groups. Cognitive assessments were administered at baseline before administration of the first dose and subsequently during the study.
Following completion of baseline assessments, subjects entered a 2 week treatment period: the experimental non-crossover group received 2 sequential escalating single doses of LSD administered at levels determined in Part 1 (50 µg followed by 75 µg, or placebo followed by 75 µg), with dosing separated by at least 7 days; the placebo controlled crossover group received placebo followed at least 7 days later by a single dose of 75 µg LSD, as determined in Part 1. Subjects were followed up on the day after each dosing, 1 week after the second dose, and at 1 month after the last dose of study treatment.
During screening, baseline, treatment and follow-up days, subjects underwent a series of assessments.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
- Model description
- In Part 1, each subject was allocated to open label treatment with a single dose of 50 µg, 75 µg, or 100 µg LSD. Part 1 was conducted in hallucinogen non-naive participants. In Part 2, each subject was randomized to double blind treatment and received 50 µg LSD followed by 75 µg LSD (experimental non-crossover group), or placebo followed by 75 µg LSD (placebo-controlled crossover group), with dosing separated by at least 7 days. Part 2 was conducted in hallucinogen naive participants.
| Arm | Type | Receives |
|---|---|---|
| Group 1 N=3 | Experimental | Drug: Lysergic Acid Diethylamide (LSD) 50µgSingle dose, follow-up visits at one day, one week, and one month after dose. |
| Group 2 N=7 | Experimental | Drug: Lysergic Acid Diethylamide (LSD) 75µgSingle dose, follow-up visits at one day, one week, and one month after dose. |
| Group 3 N=3 | Experimental | Drug: Lysergic Acid Diethylamide (LSD) 100µgSingle dose, follow-up visits at one day, one week, and one month after dose. |
| Group 4 N=10 | Experimental | Drug: Placebo/Lysergic Acid Diethylamide (LSD) 75µgRandomized treatment with placebo followed by single dose, separated by 7 days. Follow-up visits at one day, one week, and one month after last dose. |
| Group 5 N=9 | Experimental | Drug: Lysergic Acid Diethylamide (LSD) 50µg/75µgRandomized treatment with single dose followed by second dose, separated by 7 days. Follow-up visits at one day, one week, and one month after last dose. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy male or female subject aged 21 to 65 years inclusive.
- For Part 1, subject has been previously exposed to LSD or any other classic psychedelic drug, including psilocybin, mescaline, and ayahuasca, on more than 3 occasions during their lifetime. For Part 2, Subject has not been previously exposed to LSD or any other classic psychedelic drug, including psilocybin, mescaline, and ayahuasca, during the past 7 years.
- Subject was able and willing to give written informed consent, adhere to the compliance terms during participation in the study, undergo the examinations and testing set forth in the clinical study protocol, and clearly and reliably communicate their subjective experiences to the investigator.
- Female participants of childbearing potential and male participants whose partner was of childbearing potential must have been willing to ensure that they or their partner used effective contraception during the study and for 3 months after the final study drug administration.
Key exclusion criteria (26 listed)
- General Health
- Subject had a presence or clinically relevant history of any psychiatric, respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, musculoskeletal, genitourinary, immunological, dermatological, connective tissue diseases or disorders, as judged by the investigator.
- Subject had a resting blood pressure exceeding 140 mmHg (systolic) or 90 mmHg (diastolic), averaged across 4 assessments taken at least 1 minute apart on the same day.
- Subject had a presence or relevant history of organic brain disorders (e.g., intracranial hypertension, aneurisms, impaired consciousness, lethargy, or brain tumour).
- Subject had a relevant history of atopy, hypersensitivity, skin allergies, or allergic reactions to drugs.
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 Diethylamide (LSD) 50µg | Drug | Group 1 N=3 |
| Lysergic Acid Diethylamide (LSD) 75µg | Drug | Group 2 N=7 |
| Lysergic Acid Diethylamide (LSD) 100µg | Drug | Group 3 N=3 |
| Placebo/Lysergic Acid Diethylamide (LSD) 75µg | Drug | Group 4 N=10 |
| Lysergic Acid Diethylamide (LSD) 50µg/75µg | Drug | Group 5 N=9 |
Primary outcome
Assessment of Adverse Events by % frequency
Time frame: 1 year
Assessment of Adverse Events by % frequency to assess the safety and tolerability of LSD
AUC 0-24h ( pg/mL*h) over time
Time frame: 24 hours
AUC 0-24h ( pg/mL*h): area under the plasma concentration-time curve profiles from time zero to the 24 hour sample determined using the linear trapezoidal rule
Cmax (pg/mL)drug
Time frame: 24 hours
Cmax (pg/mL): maximum drug plasma concentration
Tmax (h)
Time frame: 24 hours
Tmax (h): time to reach maximum plasma concentration, T1/2 (h): time to reach half of maximum drug plasma concentration
4 secondary outcomes
Assess subjective drug effects using a VAS.
Time frame: 12 hours
Assess subjective drug effects on the 5D-ASC
Time frame: 12 hours
Assess ego dissolution by the EDI
Time frame: 12 hours
Assess the characteristics of altered states of consciousness assessed by the MEQ
Time frame: 12 hours
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 Jan 2023.
- Individual participant dataSharing planned: No
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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.
Director of Research and Development study director
Eleusis Therapeutics
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 (LSD) 50µg, Lysergic Acid Diethylamide (LSD) 75µg and Lysergic Acid Diethylamide (LSD) 100µg in people with Healthy, run by Eleusis Therapeutics at 1 site in United Kingdom.
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 4 inclusion and 26 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 Jan 2023. 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 United Kingdom. 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?
Assessment of Adverse Events by % frequency (time frame: 1 year). The study lists 4 primary outcomes in all. 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 Jan 2023.