Healthy VolunteersPhase 1NCT04421105

A Double-blind, Placebo-controlled Study to Evaluate Very Low Dose LSD in Healthy Volunteers Aged 55-75 Years

A Phase 1 study testing Lysergic acid diethylamide (LSD) 5µg, Lysergic acid diethylamide (LSD) 10µg and Lysergic acid diethylamide (LSD)20 µg in people with Healthy Volunteers, run by Eleusis Therapeutics.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 55 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: Lysergic acid diethylamide (LSD) 5µg, Lysergic acid diethylamide (LSD) 10µg and Lysergic acid diethylamide (LSD)20 µg
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 48 participants
Where: No sites listed yet
Study dates: 29 Jun 2015to 5 Nov 2015
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 55 to 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

1. Healthy male or female subjects aged 55 to 75 years, inclusive (site staff endeavoured to achieve a median age of 65 years across all subjects).
2. Subject has not been previously exposed to LSD within the past 5 years. 3. Subject is 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 study protocol, and clearly and reliably communicate their subjective symptoms to the Investigator.
4. A female subject is eligible to participate if she is postmenopausal (has experienced 12 consecutive months without menstruation).
5. A male subject with a female partner is eligible to participate if he agrees to use a double barrier method of contraception. This criterion must be followed from the time of the first dose of study medication until 3 months post-last dose. Male subjects must not donate sperm for 3 months following the last dose of study medication.

Who cannot join

General Health
Subject has a history or evidence of clinically relevant psychiatric, respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, musculoskeletal, genitourinary, immunological, dermatological, connective tissue diseases or disorders, as judged by the investigator.
Subject has resting BP exceeding 160 mmHg (systolic) and 90 mmHg (diastolic), averaged across 4 assessments taken on the same day. BP measurements were taken at least 1 min apart
Subject has a presence or relevant history of organic brain disorders (e.g. intracranial hypertension, impaired consciousness, lethargy, and brain tumour).
Subject has a relevant history of atopy, hypersensitivity, skin allergies or allergic reactions to drugs.
Subject has 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 is positive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody or human immunodeficiency virus I and II at screening.
Subject is a current smoker. (Has not smoked for at least 1 month prior to the screening visit).
Subject has a history of drug abuse/dependence in the last 12 months or has a current drug abuse/dependence, and/or is positive for drugs of abuse and alcohol tests at screening and/or baseline.
Subject has a medical history that would affect the subject's safety or the study endpoints.
Subject has used prescription drugs or therapy within 7 days of first dosing, unless agreed as non clinically relevant by the investigator and the Medical Monitor.
Subject has used over the counter (OTC) medication or therapy, including mega-dose vitamin therapy (but excluding routine vitamins) within 7 days of first dosing, unless agreed as non clinically relevant by the investigator and the Medical Monitor.
Subject has donated or received any blood or blood products within the previous 3 months prior to first dosing.
Subject cannot use a computer at the required minimum level.
Subject has used any investigational drug or participated in any clinical trial within 3 months of their first dosing.
Subject has a current sleep disorder.
Subject has a history of cataracts, active glaucoma or any other ophthalmic condition that could interfere with the eye blink assessment.
Subject has a hearing loss of more than 40 dB. Subjects with > 40dB hearing loss at less than 1500Hz were excluded Subjects with > 40dB hearing loss at 1500Hz or higher can be included in the study. The hearing result from the ear with the best hearing. Provided one ear can hear at the above levels then the patient can be included.
Subject has veins unsuitable for venipuncture and/or cannulation.
Subject has a corrected QT interval using Fridericia's correction >450 milliseconds at any single reading.
Subject is unlikely to co-operate with the requirements of the study, in the opinion of the Principal Investigator (PI) or designee.
Psychiatric health
Based on the modified SCID-CT, a subject with the lifetime presence of any of the following is excluded: psychotic symptoms that are not substance-induced or due to a medical condition or has a first- or second-degree relative with these disorders; any manic or hypomanic episode; lifetime presence of any major depressive episode; lifetime presence of substance abuse, or dependence on any substance in the past 5 years; current diagnosis of obsessive-compulsive disorder (OCD), dysthymic disorder, panic disorder, anorexia, and bulimia.
Subject is receiving chronic administration of tricyclic antidepressants or lithium or acute administration of selective serotonin reuptake inhibitors (SSRIs) or haloperidol, or serotonin-norepinephrine reuptake inhibitors (SNRIs) or monoamine oxidase inhibitors.
Subject is taking OTC doses of 5-HT or St John's Wort or Ayahuasca (which contains monoamine oxidase inhibitors in addition to dimethyltryptamine [DMT]).

About this study

Official title: A Phase 1,Single-centre, Randomised, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Very Low Dose LSD (5 µg, 10 µg, 20 µg) in Healthy Volunteers Aged 55-75 Years

This study was a Phase 1, double-blind, placebo-controlled, randomised study of very low dose LSD. Healthy volunteers aged 55 to 75 years with no use of LSD in the past 5 years were screened within 28 days of randomization. Subjects who met all inclusion and no exclusion criteria and provided written informed consent were randomised a 1:1:1:1 ratio to receive 6 doses of 5 µg, 10 µg, or 20 µg LSD or placebo, at 4-day intervals for 21 days (on Study Days 1, 5, 9, 13, 17, and 21). A follow-up visit was conducted approximately 4 weeks after the last dose of LSD. A total of 48 subjects were enrolled.

Read the detailed description

The magnitude of the effect of LSD was explored across specific PD measures.

These included:

Cognition and affect, including evaluation of memory, temporal perception, executive function, and learning
Subjective effects
Proprioception and balance

Conditions: Healthy Volunteers
Being tested: Lysergic acid diethylamide (LSD) 5µg, Lysergic acid diethylamide (LSD) 10µg, Lysergic acid diethylamide (LSD)20 µg, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Lysergic acid diethylamide (LSD) 5µgDrug
Lysergic acid diethylamide (LSD) 10µgDrug
Lysergic acid diethylamide (LSD)20 µgDrug
PlaceboDrug

Study groups in NCT04421105
Study group	Role	What they receive
Group 1 N=12	Experimental	6 doses at 4-day intervals for 21 days (on Study Days 1, 5, 9, 13, 17, and 21). A follow-up visit was conducted approximately 4 weeks after the last dose. Receives: Drug: Lysergic acid diethylamide (LSD) 5µg
Group 2 N=12	Experimental	6 doses at 4-day intervals for 21 days (on Study Days 1, 5, 9, 13, 17, and 21). A follow-up visit was conducted approximately 4 weeks after the last dose. Receives: Drug: Lysergic acid diethylamide (LSD) 10µg
Group 3 N=12	Experimental	6 doses at 4-day intervals for 21 days (on Study Days 1, 5, 9, 13, 17, and 21). A follow-up visit was conducted approximately 4 weeks after the last dose. Receives: Drug: Lysergic acid diethylamide (LSD)20 µg
Group 4 N=12	Placebo comparator	6 doses 4-day intervals for 21 days (on Study Days 1, 5, 9, 13, 17, and 21). A follow-up visit was conducted approximately 4 weeks after the last dose. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

To evaluate the safety and tolerability of very low dose LSD
Assessment of Adverse Events by % frequency
Measured: 2.5 weeks
To evaluate the pharmacokinetics of very low dose LSD - Variation of plasma concentration over time
AUC 0-12h ( pg/mL*h): area under the plasma concentration-time curve profiles from time zero to the 12 hour sample determined using the linear trapezoidal rule.
Measured: 12 hours
To evaluate the pharmacokinetics of very low dose LSD - Maximum Peak concentration of drug
Cmax (pg/mL): maximum drug plasma concentration
Measured: 12 hours
To evaluate the pharmacokinetics of very low dose LSD - Half life of drug
Tmax (h): time to reach maximum plasma concentration Tlag (h): time for drug to appear in plasma
Measured: 12 hours

Secondary outcomes (5)

To evaluate the pharmacodynamic (PD) and cumulative effect of very low dose LSD on cognition.
The CANTAB (Cambridge Neuropsychological Test Automated Battery ) included four test that measured cognitive function. These were Reaction Time (RTI) for reaction times, Paired Associates Learning (PAL) for visual memory and learning, Rapid Visual Information Processing (RVP) for sustained memory, Spatial Working Memory (SWM) for retention of visuospatial information.
Measured: 2.5 weeks
To evaluate the pharmacodynamic (PD) and cumulative effect of very low dose LSD on Acute subjective effects.
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: 2.5 weeks
To evaluate the pharmacodynamic (PD) and cumulative effect of very low dose LSD on the characteristics of altered states of consciousness assessed by questionnaire
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: 2.5 weeks
To evaluate the pharmacodynamic (PD) and cumulative effect of very low dose LSD on Balance tracking
Static balance as assessed by center of pressure (COP) using a portable force plate (Balance Tracking Systems, BTrackS™)
Measured: 2.5 weeks
To evaluate the pharmacodynamic (PD) and cumulative effect of very low dose LSD on Proprioception
The ability to sense stimuli arising within the body regarding position and motion will be measured in 15 trials during which the participant will have their arm rotated to set angles and asked to reproduce the angle while blindfolded. Performance is measured as the absolute error between the target and matching angle.
Measured: 2.5 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Jun 20155 Nov 2015

First posted9 Jun 2020
Study start29 Jun 2015
Primary completion30 Oct 2015
Study completion5 Nov 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy VolunteersStudies 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: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04421105
Sponsor's protocol ID: CAS-50-37-3-01
Status last verified: Jun 2020
First submitted: 7 May 2020
Last updated: 9 Jun 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1,Single-centre, Randomised, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Very Low Dose LSD (5 µg, 10 µg, 20 µg) in Healthy Volunteers Aged 55-75 Years
ClinicalTrials.gov ID: NCT04421105
Acronym / sponsor ID: CAS-50-37-3-01
Conditions: Healthy Volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: Eleusis TherapeuticsIndustry (pharma, biotech, devices)
Study start: 29 Jun 2015 (actual)
Primary completion: 30 Oct 2015 (actual)
Study completion: 5 Nov 2015 (actual)
First posted: 9 Jun 2020 (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.

Detailed description

The magnitude of the effect of LSD was explored across specific PD measures.

These included:

Cognition and affect, including evaluation of memory, temporal perception, executive function, and learning
Subjective effects
Proprioception and balance

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Group 1 N=12	Experimental	Drug: Lysergic acid diethylamide (LSD) 5µg6 doses at 4-day intervals for 21 days (on Study Days 1, 5, 9, 13, 17, and 21). A follow-up visit was conducted approximately 4 weeks after the last dose.
Group 2 N=12	Experimental	Drug: Lysergic acid diethylamide (LSD) 10µg6 doses at 4-day intervals for 21 days (on Study Days 1, 5, 9, 13, 17, and 21). A follow-up visit was conducted approximately 4 weeks after the last dose.
Group 3 N=12	Experimental	Drug: Lysergic acid diethylamide (LSD)20 µg6 doses at 4-day intervals for 21 days (on Study Days 1, 5, 9, 13, 17, and 21). A follow-up visit was conducted approximately 4 weeks after the last dose.
Group 4 N=12	Placebo comparator	Drug: Placebo6 doses 4-day intervals for 21 days (on Study Days 1, 5, 9, 13, 17, and 21). A follow-up visit was conducted approximately 4 weeks after the last dose.

Who may qualify

Ages: 55 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

1. Healthy male or female subjects aged 55 to 75 years, inclusive (site staff endeavoured to achieve a median age of 65 years across all subjects).
2. Subject has not been previously exposed to LSD within the past 5 years. 3. Subject is 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 study protocol, and clearly and reliably communicate their subjective symptoms to the Investigator.
4. A female subject is eligible to participate if she is postmenopausal (has experienced 12 consecutive months without menstruation).
5. A male subject with a female partner is eligible to participate if he agrees to use a double barrier method of contraception. This criterion must be followed from the time of the first dose of study medication until 3 months post-last dose. Male subjects must not donate sperm for 3 months following the last dose of study medication.

Key exclusion criteria (25 listed)

General Health
Psychiatric health
Based on the modified SCID-CT, a subject with the lifetime presence of any of the following is excluded: psychotic symptoms that are not substance-induced or due to a medical condition or has a first- or second-degree relative with these disorders; any manic or hypomanic episode; lifetime presence of any major depressive episode; lifetime presence of substance abuse, or dependence on any substance in the past 5 years; current diagnosis of obsessive-compulsive disorder (OCD), dysthymic disorder, panic disorder, anorexia, and bulimia.
Subject is receiving chronic administration of tricyclic antidepressants or lithium or acute administration of selective serotonin reuptake inhibitors (SSRIs) or haloperidol, or serotonin-norepinephrine reuptake inhibitors (SNRIs) or monoamine oxidase inhibitors.
Subject is taking OTC doses of 5-HT or St John's Wort or Ayahuasca (which contains monoamine oxidase inhibitors in addition to dimethyltryptamine [DMT]).

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) 5µg	Drug	Group 1 N=12
Lysergic acid diethylamide (LSD) 10µg	Drug	Group 2 N=12
Lysergic acid diethylamide (LSD)20 µg	Drug	Group 3 N=12
Placebo	Drug	Group 4 N=12

Primary outcome

To evaluate the safety and tolerability of very low dose LSD
Time frame: 2.5 weeks
Assessment of Adverse Events by % frequency
To evaluate the pharmacokinetics of very low dose LSD - Variation of plasma concentration over time
Time frame: 12 hours
AUC 0-12h ( pg/mL*h): area under the plasma concentration-time curve profiles from time zero to the 12 hour sample determined using the linear trapezoidal rule.
To evaluate the pharmacokinetics of very low dose LSD - Maximum Peak concentration of drug
Time frame: 12 hours
Cmax (pg/mL): maximum drug plasma concentration
To evaluate the pharmacokinetics of very low dose LSD - Half life of drug
Time frame: 12 hours
Tmax (h): time to reach maximum plasma concentration Tlag (h): time for drug to appear in plasma

5 secondary outcomes

To evaluate the pharmacodynamic (PD) and cumulative effect of very low dose LSD on cognition.
Time frame: 2.5 weeks
To evaluate the pharmacodynamic (PD) and cumulative effect of very low dose LSD on Acute subjective effects.
Time frame: 2.5 weeks
To evaluate the pharmacodynamic (PD) and cumulative effect of very low dose LSD on the characteristics of altered states of consciousness assessed by questionnaire
Time frame: 2.5 weeks
To evaluate the pharmacodynamic (PD) and cumulative effect of very low dose LSD on Balance tracking
Time frame: 2.5 weeks
To evaluate the pharmacodynamic (PD) and cumulative effect of very low dose LSD on Proprioception
Time frame: 2.5 weeks

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 9 Jun 2020.
Study publicationLink provided by the sponsor.
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.

Research and Development Director study director

Eleusis Therapeutics

Questions about this trial

What is this clinical trial studying?

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 25 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 9 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?

To evaluate the safety and tolerability of very low dose LSD (time frame: 2.5 weeks). 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?

On the ClinicalTrials.gov record for NCT04421105.

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 9 Jun 2020; AzTrials last refreshed its copy on 30 Oct 2026.