HealthyPhase 1MDMA-PsiloNCT06884514
Acute Effects of MDMA Co-administration on the Response to Psilocybin in Healthy Subjects
A Phase 1 study testing Psilocybin and 3,4-Methylenedioxymethamphetamine in people with Healthy, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
The acute subjective effects of serotonin (5-HT)2A receptor stimulation with psilocybin in humans are mostly positive. However, negative effects such as anxiety, paranoid thinking, or loss of trust towards other people are common effects, depending on the dose administered, the personality traits of the person… 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?
- Psilocybin and 3,4-Methylenedioxymethamphetamine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteSwitzerland
- Study dates
- 3 Apr 2025to 28 May 2026
- 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.
- Understanding of the German language.
- Understanding the procedures and the risks that are associated with the study.
- Participants must be willing to adhere to the protocol and sign the consent form.
- Participants must be willing to refrain from taking illicit psychoactive substances during the study.
- Participants must be willing to drink only alcohol-free liquids and no coffee, black or green tea, or energy drink after midnight of the evening before the study session, as well as during the study day.
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- Participants must be willing not to drive a traffic vehicle or to operate machines within 48 h after substance administration.
- Willing to use effective 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 in first-degree relatives, not including psychotic disorders secondary to an apparent medical reason, e.g. brain injury, dementia, or lesions of the brain.
- Hypertension (SBP>140/90 mmHg) or hypotension (SBP<85 mmHg)
- Illicit substance use (not including cannabis) more than 20 times or any time within the previous month
- Pregnant or nursing women.
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- Participation in another clinical trial (currently or within the last 30 days).
- Use of medications that may interfere with the effects of the study medications.
- Tobacco smoking (>10 cigarettes/day).
- Consumption of alcoholic drinks (>15 drinks/week).
Trial locations and contacts
1 site in 1 country.
About this study
The acute subjective effects of serotonin (5-HT)2A receptor stimulation with psilocybin in humans are mostly positive. However, negative effects such as anxiety, paranoid thinking, or loss of trust towards other people are common effects, depending on the dose administered, the personality traits of the person consuming it (set), or the environment in which psilocybin is taken (setting). Negative psychedelic effects may cause acute distress to the subject and acute anxiety has been linked to less favorable long-term outcomes in patients experimentally treated with psilocybin or similar substances for the treatment of depression. The 5-HT and oxytocin releaser 3,4-methylenedioxymethamphetamine (MDMA) reliably induces positive mood, euphoria, comfort, empathy, and feelings of trust. If administered in combination with psilocybin, MDMA may increase positive subjective drug effects including positive mood, empathy, and trust and reduce negative emotions and anxiety associated with psilocybin and overall produce a more positive over negative experience. The present study will assess subjective and autonomic effects of psilocybin alone and in combination with MDMA.
Read the detailed description
Psilocybin is a classic serotonergic psychedelic. Clinically, the acute effects of psilocybin last shorter than those of lysergic acid diethylamide (LSD) but are qualitatively very similar. Currently, psilocybin is the most investigated psychedelic substance among the classic psychedelics including LSD, psilocybin, mescaline, and dimethyltryptamine (DMT). Psilocybin is capable of inducing exceptional subjective effects such as a dream-like alteration of consciousness, affective changes, psychological insight, visual imagery, pseudo-hallucinations and ego-dissolution. The acute subjective effects elicited by psilocybin are mostly positive in humans. However, psychedelic substances like psilocybin may also cause unpleasant subjective effects like negative thoughts, rumination, anxiety, panic, paranoia, loss of trust towards other people and perceived loss of control, depending on the dose of psilocybin used, the personality traits of the person consuming it (i.e. 'set'), the environment in which it is consumed (i.e. 'setting'), and other factors. Acute negative psychological effects are considered the main risk of psychedelic substance use in humans. Inducing an overall positive acute response to the psychedelic is critical because several studies showed that a more positive experience is predictive of a greater therapeutic long-term effect of the psychedelic. The present study uses 3,4-methylenedioxymethamphetamine (MDMA) as a pharmacological tool to optimize the effects of psilocybin by inducing positive mood. MDMA is an amphetamine derivative which, unlike prototypical amphetamines, predominantly enhances serotonergic neurotransmission via release of 5-HT through the serotonin transporter (SERT). Furthermore, MDMA is known to trigger oxytocin release which may contribute to its effects to increase trust, prosociality, and enhanced empathy. The state of well-being induced by MDMA including increased activation and emotional excitation is known to be associated with a better response to psychedelics. Due to its psychological profile, MDMA could be a reliable pharmacological tool to serve as an optimizer of a psychedelic experience by inducing positive emotions.
- Conditions
- Healthy
- Being tested
- Psilocybin, 3,4-Methylenedioxymethamphetamine, Psilocybin placebo, 3,4-Methylenedioxymethamphetamine placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsilocybinDrug
A moderate dose of 20 mg psilocybin will be administered.
3,4-MethylenedioxymethamphetamineDrug
A moderate dose of 100 mg MDMA will be administered.
Psilocybin placeboDrug
Mannitol capsules instead of capsules containing psilocybin.
3,4-Methylenedioxymethamphetamine placeboDrug
Mannitol capsules instead of capsules containing MDMA.
| Study group | Role | What they receive |
|---|---|---|
| 20 mg Psilocybin + MDMA placebo | Experimental | 20 mg Psilocybin + MDMA placebo Receives: Drug: Psilocybin; Drug: 3,4-Methylenedioxymethamphetamine placebo |
| Psilocybin placebo + 100 mg MDMA | Experimental | Psilocybin placebo + 100 mg MDMA Receives: Drug: 3,4-Methylenedioxymethamphetamine; Drug: Psilocybin placebo |
| 20 mg Psilocybin + 100 mg MDMA | Experimental | 20 mg Psilocybin + 100 mg MDMA Receives: Drug: Psilocybin; Drug: 3,4-Methylenedioxymethamphetamine |
| Psilocybin placebo + MDMA placebo | Placebo comparator | Psilocybin placebo + MDMA placebo Receives: Drug: Psilocybin placebo; Drug: 3,4-Methylenedioxymethamphetamine placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Subjective effects I
The Visual Analog Scales (VAS) assesses the intensity and duration of the subjective effect on a scale from 0 - 100 percent with higher scores representing more intense effects. Assessed 12 times on each study day
Measured: through study completion, an average of 18 months
Acute Subjective effects II
The Adjective Mood Rating Scale (AMRS) assesses the occurrence and intensity of 60 moods on a 4-point Likert scale ranging from "not at all" to "extremely".
Measured: through study completion, an average of 18 months
Acute Subjective effects III
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: through study completion, an average of 18 months
Acute autonomic effects I (blood pressure)
Blood pressure (systolic and diastolic) will be measured with an automatic oscillometric device.
Measured: through study completion, an average of 18 months
Acute autonomic effects I (heart rate)
Heart rate will be measured with an automatic oscillometric device.
Measured: through study completion, an average of 18 months
Acute autonomic effects III (body temperature)
Body temperature will be measured with an ear thermometer.
Measured: through study completion, an average of 18 months
Acute autonomic effects IV (ECG QT-time)
An ECG will be performed twice: once before and once after substance administration.
Measured: through study completion, an average of 18 months
Secondary outcomes (23)
Peak plasma concentration (Cmax) of MDMA and metabolites
Assessed via blood samples. Findings will be described descriptively.
Measured: through study completion, an average of 18 months
Time to peak plasma concentration (Tmax) of MDMA and metabolites
Assessed via blood samples. Findings will be described descriptively.
Measured: through study completion, an average of 18 months
Area under the plasma concentration vs. time curve (AUC) of MDMA and metabolites
Assessed via blood samples. Findings will be described descriptively.
Measured: through study completion, an average of 18 months
Elimination half-life values of MDMA and metabolites
Assessed via blood samples. Findings will be described descriptively.
Measured: through study completion, an average of 18 months
Peak plasma concentration (Cmax) of Psilocybin and metabolites
Assessed via blood samples. Findings will be described descriptively.
Measured: through study completion, an average of 18 months
Time to peak plasma concentration (Tmax) of Psilocybin and metabolites
Assessed via blood samples. Findings will be described descriptively.
Measured: through study completion, an average of 18 months
Area under the concentration vs. time curve (AUC) of Psilocybin and metabolites
Assessed via blood samples. Findings will be described descriptively.
Measured: through study completion, an average of 18 months
Elimination half-life values of Psilocybin and metabolites
Assessed via blood samples. Findings will be described descriptively.
Measured: through study completion, an average of 18 months
Plasma concentration of Oxytocin
Assessed via blood samples.
Measured: through study completion, an average of 18 months
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: through study completion, an average of 18 months
Spiritual Realms 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 once on each study day
Measured: through study completion, an average of 18 months
Subacute effects on general and mental well-being I (WEMWBS)
The Warwick-Edinburgh Mental Well-Being Scale (WEMWBS) is a 14-item questionnaire, that covers different concepts associated with positive mental health, including both hedonic and eudaimonic aspects, positive affect, satisfying interpersonal relationships and positive functioning. For each item an ordinal five point frequency answer format, ranging from 1 = none of the time" to 5 = "all of the time" is applied.
Measured: through study completion, an average of 18 months
Subacute effects on general and mental well-being II (GHQ-12)
The General Health Questionnaire (GHQ-12) consists of a 12-item questionnaire with a four-point response scale assessing general psychological discomfort.
Measured: through study completion, an average of 18 months
Subacute effects on general and mental well-being III (SPANE)
The Scale of Positive and Negative Experience (SPANE) is a 12-item questionnaire to capture the affective component of subjective well-being. The SPANE 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: through study completion, an average of 18 months
Subacute effects on general and mental well-being IV (BFW/E)
The "Positive Attitude towards Life" is an 8-item subscale of the 39-item Bern Subjective Well-Being Questionnaire for adults. A six-point rating scale ranging from 1 ('strongly disagree') to 6 ('strongly agree') is used to rate the attitude towards life.
Measured: through study completion, an average of 18 months
Subacute effects on general and mental well-being V (GLS)
Global life satisfaction is assessed based on a single item life satisfaction measure which is a simple, yet widespread approach. The question is answered on a 11-point scale: "In general, how satisfied are you with your life if 0 means 'not at all satisfied' and 10 means 'completely satisfied'?".
Measured: through study completion, an average of 18 months
Adverse effects (acute and subacute)
The 2011 revised Beschwerden-Liste (B-LR) consists of a 40-item list covering a wide variety of symptoms and complaints that are answered with a four-point intensity-scoring ranging from "not at all" to "strong".
Measured: through study completion, an average of 18 months
Effects on Appreciation
The Appreciation Scale (AS) comprises 57 items used to measure aspects of appreciation. Subjects are asked to rate themselves 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'). Scores on the subscales are summed up to yield a score representing the overall degree of appreciation (or level of appreciativeness), with higher scores indicating more of the positive construct.
Measured: through study completion, an average of 18 months
Effect moderation by personality traits I (NEO-FFI)
Personality traits are known to affect subjective responses to psychoactive substances and are assessed for explorative future analysis of pooled data. The NEO Five Factor Inventory (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
Effect moderation by personality traits II (FPI-R)
Personality traits are known to affect subjective responses to psychoactive substances and are assessed for explorative future analysis of pooled data. The Freiburger Personality Inventory (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
Effect moderation by personality traits III (SPF)
Personality traits are known to affect subjective responses to psychoactive substances and are assessed for explorative future analysis of pooled data. The Saarbrücker Persönlichkeitsfragebogen (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
Effect moderation by personality traits IV (HEXACO)
Personality traits are known to affect subjective responses to psychoactive substances and are assessed for explorative future analysis of pooled data. 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.
Measured: Baseline
Effect moderation by personality traits V (DSQ-40)
Personality traits are known to affect subjective responses to psychoactive substances and are assessed for explorative future analysis of pooled data. The Defense Style Questionnaire (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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start3 Apr 2025
- Primary completion13 May 2026
- Study completion28 May 2026
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.
- 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, 4-period cross-over design with three active substance conditions and placebo: 1. 20 mg Psilocybin + MDMA placebo 2. Psilocybin placebo + 100 mg MDMA 3. 20 mg Psilocybin + 100 mg MDMA 4. Psilocybin placebo + MDMA placebo
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthias E Liechti, Prof. Dr. MD, Principal investigator, University Hospital Basel, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06884514
- Sponsor's protocol ID
- BASEC 2024-00893
- Acronym
- MDMA-Psilo
- Status last verified
- May 2025
- First submitted
- 31 Jan 2025
- Last updated
- 25 Jun 2026
- Results posted
- 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 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of MDMA Co-administration on the Response to Psilocybin in Healthy Subjects
- ClinicalTrials.gov ID
- NCT06884514
- Acronym / sponsor ID
- MDMA-Psilo / BASEC 2024-00893
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 3 Apr 2025 (actual)
- Primary completion
- 13 May 2026 (actual)
- Study completion
- 28 May 2026 (actual)
- First posted
- 19 Mar 2025 (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.
The acute subjective effects of serotonin (5-HT)2A receptor stimulation with psilocybin in humans are mostly positive. However, negative effects such as anxiety, paranoid thinking, or loss of trust towards other people are common effects, depending on the dose administered, the personality traits of the person consuming it (set), or the environment in which psilocybin is taken (setting). Negative psychedelic effects may cause acute distress to the subject and acute anxiety has been linked to less favorable long-term outcomes in patients experimentally treated with psilocybin or similar substances for the treatment of depression. The 5-HT and oxytocin releaser 3,4-methylenedioxymethamphetamine (MDMA) reliably induces positive mood, euphoria, comfort, empathy, and feelings of trust. If administered in combination with psilocybin, MDMA may increase positive subjective drug effects including positive mood, empathy, and trust and reduce negative emotions and anxiety associated with psilocybin and overall produce a more positive over negative experience. The present study will assess subjective and autonomic effects of psilocybin alone and in combination with MDMA.
Detailed description
Psilocybin is a classic serotonergic psychedelic. Clinically, the acute effects of psilocybin last shorter than those of lysergic acid diethylamide (LSD) but are qualitatively very similar. Currently, psilocybin is the most investigated psychedelic substance among the classic psychedelics including LSD, psilocybin, mescaline, and dimethyltryptamine (DMT). Psilocybin is capable of inducing exceptional subjective effects such as a dream-like alteration of consciousness, affective changes, psychological insight, visual imagery, pseudo-hallucinations and ego-dissolution. The acute subjective effects elicited by psilocybin are mostly positive in humans. However, psychedelic substances like psilocybin may also cause unpleasant subjective effects like negative thoughts, rumination, anxiety, panic, paranoia, loss of trust towards other people and perceived loss of control, depending on the dose of psilocybin used, the personality traits of the person consuming it (i.e. 'set'), the environment in which it is consumed (i.e. 'setting'), and other factors. Acute negative psychological effects are considered the main risk of psychedelic substance use in humans. Inducing an overall positive acute response to the psychedelic is critical because several studies showed that a more positive experience is predictive of a greater therapeutic long-term effect of the psychedelic. The present study uses 3,4-methylenedioxymethamphetamine (MDMA) as a pharmacological tool to optimize the effects of psilocybin by inducing positive mood. MDMA is an amphetamine derivative which, unlike prototypical amphetamines, predominantly enhances serotonergic neurotransmission via release of 5-HT through the serotonin transporter (SERT). Furthermore, MDMA is known to trigger oxytocin release which may contribute to its effects to increase trust, prosociality, and enhanced empathy. The state of well-being induced by MDMA including increased activation and emotional excitation is known to be associated with a better response to psychedelics. Due to its psychological profile, MDMA could be a reliable pharmacological tool to serve as an optimizer of a psychedelic experience by inducing positive emotions.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
- Model description
- Double-blind, placebo-controlled, 4-period cross-over design with three active substance conditions and placebo: 1. 20 mg Psilocybin + MDMA placebo 2. Psilocybin placebo + 100 mg MDMA 3. 20 mg Psilocybin + 100 mg MDMA 4. Psilocybin placebo + MDMA placebo
| Arm | Type | Receives |
|---|---|---|
| 20 mg Psilocybin + MDMA placebo | Experimental | Drug: Psilocybin, Drug: 3,4-Methylenedioxymethamphetamine placebo20 mg Psilocybin + MDMA placebo |
| Psilocybin placebo + 100 mg MDMA | Experimental | Drug: 3,4-Methylenedioxymethamphetamine, Drug: Psilocybin placeboPsilocybin placebo + 100 mg MDMA |
| 20 mg Psilocybin + 100 mg MDMA | Experimental | Drug: Psilocybin, Drug: 3,4-Methylenedioxymethamphetamine20 mg Psilocybin + 100 mg MDMA |
| Psilocybin placebo + MDMA placebo | Placebo comparator | Drug: Psilocybin placebo, Drug: 3,4-Methylenedioxymethamphetamine placeboPsilocybin placebo + MDMA placebo |
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.
- Understanding of the German language.
- Understanding the procedures and the risks that are associated with the study.
- Participants must be willing to adhere to the protocol and sign the consent form.
- Participants must be willing to refrain from taking illicit psychoactive substances during the study.
Key exclusion criteria (10 listed)
- Chronic or acute medical condition
- Current or previous major psychiatric disorder
- Psychotic disorder in first-degree relatives, not including psychotic disorders secondary to an apparent medical reason, e.g. brain injury, dementia, or lesions of the brain.
- Hypertension (SBP>140/90 mmHg) or hypotension (SBP<85 mmHg)
- Illicit substance use (not including cannabis) more than 20 times or any time within the previous month
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 |
|---|---|---|
| PsilocybinA moderate dose of 20 mg psilocybin will be administered. | Drug | 20 mg Psilocybin + 100 mg MDMA, 20 mg Psilocybin + MDMA placebo |
| 3,4-MethylenedioxymethamphetamineA moderate dose of 100 mg MDMA will be administered. | Drug | 20 mg Psilocybin + 100 mg MDMA, Psilocybin placebo + 100 mg MDMA |
| Psilocybin placeboMannitol capsules instead of capsules containing psilocybin. | Drug | Psilocybin placebo + 100 mg MDMA, Psilocybin placebo + MDMA placebo |
| 3,4-Methylenedioxymethamphetamine placeboMannitol capsules instead of capsules containing MDMA. | Drug | 20 mg Psilocybin + MDMA placebo, Psilocybin placebo + MDMA placebo |
Primary outcome
Acute Subjective effects I
Time frame: through study completion, an average of 18 months
The Visual Analog Scales (VAS) assesses the intensity and duration of the subjective effect on a scale from 0 - 100 percent with higher scores representing more intense effects. Assessed 12 times on each study day
Acute Subjective effects II
Time frame: through study completion, an average of 18 months
The Adjective Mood Rating Scale (AMRS) assesses the occurrence and intensity of 60 moods on a 4-point Likert scale ranging from "not at all" to "extremely".
Acute Subjective effects III
Time frame: through study completion, an average of 18 months
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.
Acute autonomic effects I (blood pressure)
Time frame: through study completion, an average of 18 months
Blood pressure (systolic and diastolic) will be measured with an automatic oscillometric device.
Acute autonomic effects I (heart rate)
Time frame: through study completion, an average of 18 months
Heart rate will be measured with an automatic oscillometric device.
Acute autonomic effects III (body temperature)
Time frame: through study completion, an average of 18 months
Body temperature will be measured with an ear thermometer.
Acute autonomic effects IV (ECG QT-time)
Time frame: through study completion, an average of 18 months
An ECG will be performed twice: once before and once after substance administration.
23 secondary outcomes
Peak plasma concentration (Cmax) of MDMA and metabolites
Time frame: through study completion, an average of 18 months
Time to peak plasma concentration (Tmax) of MDMA and metabolites
Time frame: through study completion, an average of 18 months
Area under the plasma concentration vs. time curve (AUC) of MDMA and metabolites
Time frame: through study completion, an average of 18 months
Elimination half-life values of MDMA and metabolites
Time frame: through study completion, an average of 18 months
Peak plasma concentration (Cmax) of Psilocybin and metabolites
Time frame: through study completion, an average of 18 months
Time to peak plasma concentration (Tmax) of Psilocybin and metabolites
Time frame: through study completion, an average of 18 months
Area under the concentration vs. time curve (AUC) of Psilocybin and metabolites
Time frame: through study completion, an average of 18 months
Elimination half-life values of Psilocybin and metabolites
Time frame: through study completion, an average of 18 months
Plasma concentration of Oxytocin
Time frame: through study completion, an average of 18 months
States of Consciousness Questionnaire
Time frame: through study completion, an average of 18 months
Spiritual Realms Questionnaire
Time frame: through study completion, an average of 18 months
Subacute effects on general and mental well-being I (WEMWBS)
Time frame: through study completion, an average of 18 months
Subacute effects on general and mental well-being II (GHQ-12)
Time frame: through study completion, an average of 18 months
Subacute effects on general and mental well-being III (SPANE)
Time frame: through study completion, an average of 18 months
Subacute effects on general and mental well-being IV (BFW/E)
Time frame: through study completion, an average of 18 months
Subacute effects on general and mental well-being V (GLS)
Time frame: through study completion, an average of 18 months
Adverse effects (acute and subacute)
Time frame: through study completion, an average of 18 months
Effects on Appreciation
Time frame: through study completion, an average of 18 months
Effect moderation by personality traits I (NEO-FFI)
Time frame: Baseline
Effect moderation by personality traits II (FPI-R)
Time frame: Baseline
Effect moderation by personality traits III (SPF)
Time frame: Baseline
Effect moderation by personality traits IV (HEXACO)
Time frame: Baseline
Effect moderation by personality traits V (DSQ-40)
Time frame: Baseline
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 25 Jun 2026.
- 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.
Matthias E Liechti, Prof. Dr. MD principal investigator
University Hospital Basel, 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 Psilocybin and 3,4-Methylenedioxymethamphetamine 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 25 Jun 2026. 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?
Acute Subjective effects I (time frame: through study completion, an average of 18 months). The study lists 7 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 25 Jun 2026.