HealthyPhase 1LSD-BioNCT04865653
LSD Base and LSD Tartrate Bioequivalence and Bioavailability in Healthy Subjects
A Phase 1 study testing Lysergic Acid Diethylamide Base oral drinking solution, Lysergic Acid Diethylamide Base solid orodispersible film and Lysergic Acid Diethylamide Tartrate oral drinking solution in people with Healthy, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
Lysergic acid diethylamide (LSD) is used as recreational substance and as a research substance to study the mind. Recreationally, LSD is typically used in the form of "blotters" containing LSD tartrate. In research, both LSD base (LSD alone) or LSD salt in the form of LSD tartrate are used. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Lysergic Acid Diethylamide Base oral drinking solution, Lysergic Acid Diethylamide Base solid orodispersible film and Lysergic Acid Diethylamide Tartrate oral drinking solution
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- 17 Mar 2022to 11 Oct 2023
- 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 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age between 25 and 65 years old
- Sufficient understanding of the German language
- Understanding of procedures and risks associated with the study
- Willing to adhere to the protocol and signing of the consent form
- Willing to refrain from the consumption of illicit psychoactive substances during the study
- Abstaining from xanthine-based liquids from the evenings prior to the study sessions to the end of the study days
Show all 9Show fewer
- Willing not to operate heavy machinery within 48 hours after substance administration
- Willing to use double-barrier birth control throughout study participation
- Body mass index between 18-29 kg/m2
Who cannot join
- Chronic or acute medical condition
- Current or previous major psychiatric disorder
- Psychotic disorder or bipolar disorder in first-degree relatives
- Hypertension (>140/90 mmHg) or hypotension (SBP<85 mmHg)
- Hallucinogenic substance use (not including cannabis) more than 20 times or any time within the previous two months
- Pregnancy or current breastfeeding
Show all 10Show fewer
- Participation in another clinical trial (currently or within the last 30 days)
- Use of medication that may interfere with the effects of the study medication
- Tobacco smoking (>10 cigarettes/day)
- Consumption of alcoholic beverages (>20 drinks/week)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Clinical Pharmacology & Toxicology, University Hospital Basel
Basel, 4031
About this study
Lysergic acid diethylamide (LSD) is used as recreational substance and as a research substance to study the mind. Recreationally, LSD is typically used in the form of "blotters" containing LSD tartrate. In research, both LSD base (LSD alone) or LSD salt in the form of LSD tartrate are used. The oral bioavailability of LSD is not known and LSD alone and LSD as salt have never been directly compared regarding their equivalence of plasma concentrations and effects. Because different forms of LSD are used in research it is important to know their difference or equivalence for correct dosing of LSD. The present study will compare equivalent doses of LSD base in ethanol orally, LSD tartrate in water administered orally, LSD base in an orodispersible film administered orally and LSD tartrate in water administered intravenously, as well as a placebo using a double-blind, randomized, counterballanced cross-over design in healthy participants.
Read the detailed description
LSD is widely used for recreational and spiritual purposes. Additionally LSD is currently reused in experimental studies with healthy subjects and in studies investigating its effects on patients suffering from anxiety, depression, addiction personality disorders, cluster headache, migraine, and other pathological conditions.
When LSD is used recreationally, it is administered mostly in the form of LSD tartrate on filter paper (blotter) or as a liquid. In experimental research over the past years, LSD has mostly been used in the form of LSD base, which is lipophilic and therefore has typically been administered as a solution in ethanol. However, some researchers have also use LSD tartrate orally or LSD base intravenously. Currently, it is not clear how these different forms of LSD compare regarding their bioequivalence and effects.
The present study therefore compares four different formulations of LSD and placebo: (1) An oral drinking solution of LSD base currently used in many research studies (100 μg LSD in 96% ethanol), (2) A solid orodispersible film containing LSD base (100 μg LSD), (3) LSD tartrate used in research and recreationally (100 μg LSD equivalent of LSD tartrate in water), (4) an intravenous administration of LSD tartrate (100 μg LSD equivalent of LSD tartrate in water), and (5) placebo for all formulations (quadruple-dummy). The primary goals are to document the bioequivalence of LSD base (1) and tartrate (3) and to define the oral bioavailability of LSD using an additional intravenous LSD administration.
- Conditions
- Healthy
- Being tested
- Lysergic Acid Diethylamide Base oral drinking solution, Lysergic Acid Diethylamide Base solid orodispersible film, Lysergic Acid Diethylamide Tartrate oral drinking solution, Lysergic Acid Diethylamide Tartrate intravenous administration, LSD Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lysergic Acid Diethylamide Base oral drinking solutionDrug
Also called LSD
A moderate dose of 0.1 mg LSD will be administered.
Lysergic Acid Diethylamide Base solid orodispersible filmDrug
Also called LSD
A moderate dose of 0.1 mg LSD will be administered.
Lysergic Acid Diethylamide Tartrate oral drinking solutionDrug
Also called LSD
A moderate dose of 0.146 mg LSD tartrate will be administered (equivalent to 0.1 mg LSD base).
Lysergic Acid Diethylamide Tartrate intravenous administrationDrug
Also called LSD
A moderate dose of 0.146 mg LSD tartrate will be administered (equivalent to 0.1 mg LSD base).
LSD PlaceboOther
Also called Placebo
Placebo for each formulation containing only the solvent or gel but no LSD.
| Study group | Role | What they receive |
|---|---|---|
| Oral drinking solution of LSD base | Experimental | Oral drinking solution of 0.1 mg LSD base in 96% ethanol Receives: Drug: Lysergic Acid Diethylamide Base oral drinking solution |
| Solid orodispersible film containing LSD base | Experimental | Solid orodispersible film containing 0.1 mg LSD base Receives: Drug: Lysergic Acid Diethylamide Base solid orodispersible film |
| Oral drinking solution of LSD tartrate | Experimental | Oral drinking solution of 0.146 mg LSD tartrate in water Receives: Drug: Lysergic Acid Diethylamide Tartrate oral drinking solution |
| Intravenous administration of LSD tartrate | Experimental | Intravenous administration of 0.146 mg LSD tartrate in water Receives: Drug: Lysergic Acid Diethylamide Tartrate intravenous administration |
| Placebo | Placebo comparator | Placebo for all formulations Receives: Other: LSD Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
LSD plasma AUC
Assessed 22 times on each study day via blood samples
Measured: 18 months
LSD Cmax
Assessed 22 times on each study day via blood samples
Measured: 18 months
Bioavailability of LSD base
Assessed 22 times on each study day via blood samples
Measured: 18 months
Bioavailability of LSD tartrate
Assessed 22 times on each study day via blood samples
Measured: 18 months
Secondary outcomes (18)
Acute subjective effects I
Visual Analog Scales (VAS) assessing the intensity and duration of subjective effects on a scale from 0% - 100% with higher scores representing more intense effects
Measured: 18 months
Acute subjective effects II
5 Dimensions of Altered States of Consciousness (5D-ASC) consisting of 94 items to be rated on a visual analog scale (0-100 mm), with higher values indicating stronger effects
Measured: 18 months
Acute subjective effects III
Spiritual Realm Questionnaire assesses the spiritual phenomenons elicited by psychedelic substances through 11 main questions to be answered on a total of 65 sub-ordered 100mm visual analog scales
Measured: 18 months
Acute subjective effects IV
States of Consciousness Questionnaire assesses the emergence and intensity of phenomenons occurring in altered states of consciousness on a 6-point Likert scale ranging from 0 ("not at all") to 5 ("extremely")
Measured: 18 months
Autonomic effects I
Assessed 23 times on each study day via systolic and diastolic blood pressure
Measured: 18 months
Autonomic effects II
Assessed 23 times on each study day via heart rate
Measured: 18 months
Autonomic effects III
Assessed 23 times on each study day via tympanic body temperature
Measured: 18 months
Bioavailability of orodispersible film
Assessed 22 times on each study day via blood samples
Measured: 18 months
NEO-Five-Factor-Inventory (NEO-FFI)
The NEO-FFI is a self-description questionnaire with 60 items for the measurement of the "big five": neuroticism, extraversion, openness, agreeableness, and consciousness. It uses a 5-point Likert scale ranging from "completely disagree" to "fully agree".
Measured: Baseline
Freiburger Personality Inventory (FPI-R)
The FPI-R version comprises 138 items and covers 12 dimensions of personality: life satisfaction, social orientation, performance orientation, inhibition, excitability, aggressiveness, stress, physical complaints, health concerns, openness, as well as the secondary factors according to Eysenck's Extraversion and Emotionality (Neuroticism). It uses a 2-point scale ("true" and "not true").
Measured: Baseline
Saarbrücker Personality Questionnaire (SPF)
The SPF defines empathy as the "reactions of one individual to the observed experiences of another." It assesses 28-items on a 5-point Likert scale ranging from "Does not describe me well" to "Describes me very well". The measure has 4 subscales (Perspective Taking, Fantasy, Empathic Concern, Personal Distress) each made up of 7 different items.
Measured: Baseline
HEXACO personality inventory
The HEXACO personality inventory is a six-dimensional model of human personality with 100 items.The six factors are: Honesty-Humility, Emotionality, Extraversion, Agreeableness, Conscientiousness and Openness to Experience. The HEXACO uses a 5-point Likert scale ranging from "completely disagree" to "fully agree".
Measured: Baseline
Defense Style Questionnaire (DSQ-40)
The DSQ-40 can provide scores for 20 individual defenses, and scores for the three factors "mature", "neurotic", and "immature". Each item is evaluated on a scale from 1 to 9, where "1" indicates "completely disagree" and "9" indicates "fully agree".
Measured: Baseline
Absence of tolerance
Absence of tolerance (no significant order effect) with repeated dosing of LSD with a between dosing interval of at least 10 days assessed with Visual Analog Scales (any drug response over time)
Measured: 18 months
Appreciation Scale (AS)
The Appreciation Scale comprises 57 items used to measure eight aspects of appreciation. The eight subscales are respectively focus on what one has ("Have" Focus), Awe, Ritual, Present Moment, Self/Social Comparison, Gratitude, Loss/Adversity, and Interpersonal. Each item is evaluated on a scale from 1 to 7 in terms of either attitude intensity ("strongly disagree" to "strongly agree") or frequency ("never" to "more than once a day").
Measured: Baseline
Subjective well-being I
The Scale of Positive and Negative Experience (SPANE) is a 12-item questionnaire to capture the affective component of subjective well-being. It includes six items to assess positive feelings and six items to assess negative feelings. The feelings are reported on a 5-point scale ranging from "very rarely" to "very often or always".
Measured: 18 months
Subjective well-being II
The Positive Attitude towards life is an 8-item subscale of the 39-item Bern Subjective Well-Being Questionnaire and assesses different dimensions of subjective well-being. Evaluations are made using a six-point rating scale ranging from 1 ("strongly disagree") to 6 ("strongly agree").
Measured: 18 months
Subjective well-being III
Global Life Satisfaction (GLS) is assessed on a single item life satisfaction measure. The question is answered on a 11-point scale with 0 as "not at all satisfied with your life" and 10 " completely satisfied.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2021
- Study start17 Mar 2022
- Primary completion11 Oct 2023
- Study completion11 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- 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, 5-period cross-over design with five treatment conditions: 1. Oral drinking solution of 0.1 mg LSD base in 96% ethanol 2. Solid orodispersible film containing 0.1 mg LSD base 3. Oral drinking solution of 0.146 mg LSD tartrate in water (equivalent to 0.1 mg LSD base) 4. Intravenous administration of 0.146 mg LSD tartrate in water (equivalent to 0.1 mg LSD base) 5. Placebo
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthias E Liechti, MD, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04865653
- Sponsor's protocol ID
- BASEC 2020-02331
- Acronym
- LSD-Bio
- Status last verified
- Feb 2024
- First submitted
- 26 Apr 2021
- Last updated
- 14 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Arikci D, Holze F, Mueller L, Vizeli P, Rudin D, Luethi D, Hysek CM, Liechti ME. Absolute Oral Bioavailability and Bioequivalence of LSD Base and Tartrate in a Double-Blind, Placebo-Controlled, Crossover Study. Clin Pharmacol Ther. 2025 Sep;118(3):735-743. doi: 10.1002/cpt.3726. Epub 2025 May 26.
PubMed 40418105
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LSD Base and LSD Tartrate Bioequivalence and Bioavailability in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04865653
- Acronym / sponsor ID
- LSD-Bio / BASEC 2020-02331
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 17 Mar 2022 (actual)
- Primary completion
- 11 Oct 2023 (actual)
- Study completion
- 11 Oct 2023 (actual)
- First posted
- 29 Apr 2021 (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.
Lysergic acid diethylamide (LSD) is used as recreational substance and as a research substance to study the mind. Recreationally, LSD is typically used in the form of "blotters" containing LSD tartrate. In research, both LSD base (LSD alone) or LSD salt in the form of LSD tartrate are used. The oral bioavailability of LSD is not known and LSD alone and LSD as salt have never been directly compared regarding their equivalence of plasma concentrations and effects. Because different forms of LSD are used in research it is important to know their difference or equivalence for correct dosing of LSD. The present study will compare equivalent doses of LSD base in ethanol orally, LSD tartrate in water administered orally, LSD base in an orodispersible film administered orally and LSD tartrate in water administered intravenously, as well as a placebo using a double-blind, randomized, counterballanced cross-over design in healthy participants.
Detailed description
LSD is widely used for recreational and spiritual purposes. Additionally LSD is currently reused in experimental studies with healthy subjects and in studies investigating its effects on patients suffering from anxiety, depression, addiction personality disorders, cluster headache, migraine, and other pathological conditions.
When LSD is used recreationally, it is administered mostly in the form of LSD tartrate on filter paper (blotter) or as a liquid. In experimental research over the past years, LSD has mostly been used in the form of LSD base, which is lipophilic and therefore has typically been administered as a solution in ethanol. However, some researchers have also use LSD tartrate orally or LSD base intravenously. Currently, it is not clear how these different forms of LSD compare regarding their bioequivalence and effects.
The present study therefore compares four different formulations of LSD and placebo: (1) An oral drinking solution of LSD base currently used in many research studies (100 μg LSD in 96% ethanol), (2) A solid orodispersible film containing LSD base (100 μg LSD), (3) LSD tartrate used in research and recreationally (100 μg LSD equivalent of LSD tartrate in water), (4) an intravenous administration of LSD tartrate (100 μg LSD equivalent of LSD tartrate in water), and (5) placebo for all formulations (quadruple-dummy). The primary goals are to document the bioequivalence of LSD base (1) and tartrate (3) and to define the oral bioavailability of LSD using an additional intravenous LSD administration.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
- Model description
- Double-blind, placebo-controlled, 5-period cross-over design with five treatment conditions: 1. Oral drinking solution of 0.1 mg LSD base in 96% ethanol 2. Solid orodispersible film containing 0.1 mg LSD base 3. Oral drinking solution of 0.146 mg LSD tartrate in water (equivalent to 0.1 mg LSD base) 4. Intravenous administration of 0.146 mg LSD tartrate in water (equivalent to 0.1 mg LSD base) 5. Placebo
| Arm | Type | Receives |
|---|---|---|
| Oral drinking solution of LSD base | Experimental | Drug: Lysergic Acid Diethylamide Base oral drinking solutionOral drinking solution of 0.1 mg LSD base in 96% ethanol |
| Solid orodispersible film containing LSD base | Experimental | Drug: Lysergic Acid Diethylamide Base solid orodispersible filmSolid orodispersible film containing 0.1 mg LSD base |
| Oral drinking solution of LSD tartrate | Experimental | Drug: Lysergic Acid Diethylamide Tartrate oral drinking solutionOral drinking solution of 0.146 mg LSD tartrate in water |
| Intravenous administration of LSD tartrate | Experimental | Drug: Lysergic Acid Diethylamide Tartrate intravenous administrationIntravenous administration of 0.146 mg LSD tartrate in water |
| Placebo | Placebo comparator | Other: LSD PlaceboPlacebo for all formulations |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age between 25 and 65 years old
- Sufficient understanding of the German language
- Understanding of procedures and risks associated with the study
- Willing to adhere to the protocol and signing of the consent form
- Willing to refrain from the consumption of illicit psychoactive substances during the study
Key exclusion criteria (10 listed)
- Chronic or acute medical condition
- Current or previous major psychiatric disorder
- Psychotic disorder or bipolar disorder in first-degree relatives
- Hypertension (>140/90 mmHg) or hypotension (SBP<85 mmHg)
- Hallucinogenic substance use (not including cannabis) more than 20 times or any time within the previous two months
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 Base oral drinking solutionAlso: LSDA moderate dose of 0.1 mg LSD will be administered. | Drug | Oral drinking solution of LSD base |
| Lysergic Acid Diethylamide Base solid orodispersible filmAlso: LSDA moderate dose of 0.1 mg LSD will be administered. | Drug | Solid orodispersible film containing LSD base |
| Lysergic Acid Diethylamide Tartrate oral drinking solutionAlso: LSDA moderate dose of 0.146 mg LSD tartrate will be administered (equivalent to 0.1 mg LSD base). | Drug | Oral drinking solution of LSD tartrate |
| Lysergic Acid Diethylamide Tartrate intravenous administrationAlso: LSDA moderate dose of 0.146 mg LSD tartrate will be administered (equivalent to 0.1 mg LSD base). | Drug | Intravenous administration of LSD tartrate |
| LSD PlaceboAlso: PlaceboPlacebo for each formulation containing only the solvent or gel but no LSD. | Other | Placebo |
Primary outcome
LSD plasma AUC
Time frame: 18 months
Assessed 22 times on each study day via blood samples
LSD Cmax
Time frame: 18 months
Assessed 22 times on each study day via blood samples
Bioavailability of LSD base
Time frame: 18 months
Assessed 22 times on each study day via blood samples
Bioavailability of LSD tartrate
Time frame: 18 months
Assessed 22 times on each study day via blood samples
18 secondary outcomes
Acute subjective effects I
Time frame: 18 months
Acute subjective effects II
Time frame: 18 months
Acute subjective effects III
Time frame: 18 months
Acute subjective effects IV
Time frame: 18 months
Autonomic effects I
Time frame: 18 months
Autonomic effects II
Time frame: 18 months
Autonomic effects III
Time frame: 18 months
Bioavailability of orodispersible film
Time frame: 18 months
NEO-Five-Factor-Inventory (NEO-FFI)
Time frame: Baseline
Freiburger Personality Inventory (FPI-R)
Time frame: Baseline
Saarbrücker Personality Questionnaire (SPF)
Time frame: Baseline
HEXACO personality inventory
Time frame: Baseline
Defense Style Questionnaire (DSQ-40)
Time frame: Baseline
Absence of tolerance
Time frame: 18 months
Appreciation Scale (AS)
Time frame: Baseline
Subjective well-being I
Time frame: 18 months
Subjective well-being II
Time frame: 18 months
Subjective well-being III
Time frame: 18 months
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 14 Feb 2024.
- Derived from this study: PubMed 40418105Arikci D, Holze F, Mueller L, Vizeli P, Rudin D, Luethi D, Hysek CM, Liechti ME. Absolute Oral Bioavailability and Bioequivalence of LSD Base and Tartrate in a Double-Blind, Placebo-Controlled, Crossover Study. Clin Pharmacol Ther. 2025 Sep;118(3):735-743. doi: 10.1002/cpt.3726. Epub 2025 May 26.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
Matthias E Liechti, MD principal investigator
University Hospital, Basel, Switzerland
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 Base oral drinking solution, Lysergic Acid Diethylamide Base solid orodispersible film and Lysergic Acid Diethylamide Tartrate oral drinking solution in people with Healthy, run by University Hospital, Basel, Switzerland 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 9 inclusion and 10 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 14 Feb 2024. 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. 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?
LSD plasma AUC (time frame: 18 months). 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 NCT04865653, which also lists 1 linked publication.
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 14 Feb 2024.