HealthyPhase 1MDMA-likeNCT04847206
Effects of MDMA-like Substances in Healthy Subjects
A Phase 1 study testing 3,4-methylenedioxymethamphetamine, 3,4-methylenedioxyamphetamine and lysine-3,4-methylenedioxymethamphetamine in people with Healthy, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
The serotonin (5-HT) and oxytocin releaser and so-called "empathogen" 3,4-methylenedioxymethamphetamine (MDMA) acutely produces positive feelings, empathy, and trust. MDMA is used recreationally (ecstasy), as research tool to study 5-HT and oxytocin function, and is investigated for MDMA-assisted psychotherapy. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- 3,4-methylenedioxymethamphetamine, 3,4-methylenedioxyamphetamine and lysine-3,4-methylenedioxymethamphetamine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Dec 2021to 18 Jun 2024
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age between 18 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 or MDMA use more than 20 times or use of any illicit substance within the previous two months (not including cannabis)
- 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
University Hospital Basel, Clinical Trial Unit
Basel, Canton of Basel-City, 4056
About this study
The serotonin (5-HT) and oxytocin releaser and so-called "empathogen" 3,4-methylenedioxymethamphetamine (MDMA) acutely produces positive feelings, empathy, and trust. MDMA is used recreationally (ecstasy), as research tool to study 5-HT and oxytocin function, and is investigated for MDMA-assisted psychotherapy.
MDMA is metabolized in part (10%) to the psychoactive metabolite 3,4-methylenedioxyamphetamine (MDA) which itself is also a recreational substance and has also been used to assist psychotherapy in the past. The present study aims to describe and directly compare for the first time the effects of MDMA and MDA in the same healthy volunteers and using modern psychological and psychometric tests.
Additionally, although amphetamines including MDMA and MDA induce mainly positive subjective effects they may also produce negative subjective drug effects including anxiety in particular at the onset of the subjective response and the rapid onset of euphoria may increase the risk of abuse. Additionally, blood pressure may increase rapidly at drug onset. A possible solution to mitigate anxiety, abuse-related rapid euphoria increases and/or rapid blood pressure changes at onset consist of slowing the onset of the drug effect by using a slow-release formulation of MDMA. In the present study, the investigators will characterize the effects of lysine-MDMA and lysine-MDA and compare their effects with MDMA/MDA to test the concept of attenuated effects across both substances.
Read the detailed description
3,4-methylenedioxymethamphetamine (MDMA) is used as recreational substance (Ecstasy), research tool to stimulate serotonin (5-HT) and oxytocin release and study associated mood states, and as a potential therapeutic substance to enhance psychotherapy for post-traumatic stress disorder. MDMA is an amphetamine derivative which, unlike prototypical amphetamines, predominantly enhances serotonergic neurotransmission via release of 5-HT through the SERT and it less potently also releases dopamine and norepinephrine through the DA transporter and NE transporter, respectively. Furthermore, MDMA is known to trigger oxytocin release which may contribute to its effects to increase trust, prosociality, and enhance empathy. MDMA is therefore referred to as an "entactogen" or "empathogen". MDMA is currently the only empathogen investigated in substance-assisted psychotherapy but other substances including the MDMA-metabolite 3,4-methylenedioxyamphetamine (MDA) have been used in the past or may be used in the future.
Aim 1: MDA may exert greater perceptual psychedelic-like effects due to a more potent binding to the serotonin 5-HT2A receptor, and it may also act longer than MDMA partly due to a longer plasma half-life. However, effects of MDMA and MDA have never been compared directly in the same study in humans and there is only one modern study that characterized MDA in humans. Therefore, the present study aims to describe and directly compare for the first time the effects of MDMA and MDA in the same healthy volunteers using modern and sensitive psychological and psychometric tests.
Aim 2: Additionally, although amphetamines including MDMA and MDA induce mainly positive subjective effects they may also produce negative subjective drug effects including anxiety in particular at the onset of the subjective response and the rapid onset of euphoria may increase abuse liability. Additionally, blood pressure may increase rapidly at drug onset. A possible solution to mitigate anxiety, abuse-related rapid euphoria increases and/or rapid blood pressure changes at onset consist of slowing the onset of the drug effect by using a slow-release formulation of MDMA/MDA. Alternatively, amphetamines can be linked to the endogenous amino acid lysine forming inactive lysine-amphetamine which then liberates the active amphetamine slowly in the circulation via plasma peptidases. This approach has been implemented with the medication Lisdexamfetamine, which combines lysine with d-amphetamine. In the present study, the investigators will similarly characterize the effects of lysine-MDMA and lysine-MDA to test for attenuated effects across both substances in comparison with MDMA/MDA.
Using a two-factorial study design with four active substance conditions (MDMA vs. MDA and lysine-MDMA vs. lysine-MDA) the investigators will be able to test differences between MDMA and MDA (with and without lysine) as well as between lysinated a non-lysinated substance (regardless of active substance) in the same study and with high statistical power and within one study addressing two aims.
- Conditions
- Healthy
- Being tested
- 3,4-methylenedioxymethamphetamine, 3,4-methylenedioxyamphetamine, lysine-3,4-methylenedioxymethamphetamine, lysine-3,4-methylenedioxyamphetamine, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3,4-methylenedioxymethamphetamineDrug
Also called MDMA
A moderate dose of 100 mg MDMA will be administered.
3,4-methylenedioxyamphetamineDrug
Also called MDA
A moderate dose of 93.9 mg MDA will be administered.
lysine-3,4-methylenedioxymethamphetamineDrug
Also called lysine-MDMA
A moderate dose of 171.7 mg lysine-MDMA will be administered.
lysine-3,4-methylenedioxyamphetamineDrug
Also called lysine-MDA
A moderate dose of 165.6 mg lysine-MDA will be administered.
PlaceboOther
Placebo (Mannitol)
| Study group | Role | What they receive |
|---|---|---|
| MDMA (100 mg MDMA-hydrochloride) | Experimental | MDMA (100 mg MDMA-hydrochloride; 84.1 mg MDMA free base) Receives: Drug: 3,4-methylenedioxymethamphetamine |
| MDA (93.9 mg MDA-hydrochloride) | Experimental | MDA (93.9 mg MDA-hydrochloride; 78.0 mg MDA free base) Receives: Drug: 3,4-methylenedioxyamphetamine |
| lysine-MDMA (171.7mg lysMDMA dihydrochloride | Experimental | lysine-MDMA (171.7mg lysMDMA dihydrochloride; 84.1 mg MDMA free base) Receives: Drug: lysine-3,4-methylenedioxymethamphetamine |
| lysine-MDA (165.6 mg lysMDA dihydrochloride; | Experimental | lysine-MDA (165.6 mg lysMDA dihydrochloride; 78.0 mg MDA free base) Receives: Drug: lysine-3,4-methylenedioxyamphetamine |
| Placebo | Placebo comparator | Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute subjective effects I
Visual Analog Scales (VAS) assessing the intensity and duration of subjective effects on a scale from 0 - 100 percent with higher scores representing more intense effects
Measured: 18 months
Plasma levels of MDMA
Assessed 18 times on each study day via blood samples
Measured: 18 months
Plasma levels of MDA
Assessed 18 times on each study day via blood samples
Measured: 18 months
Secondary outcomes (17)
Acute Subjective effects II
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: 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: 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: 18 months
Psychological Insight Questionnaire
Assesses the degree of psychological insight caused by a psychedelic experience through 14-items to be answered on a 6-point Likert scale ranging from 0 ("not at all") to 5 ("extremely")
Measured: 18 months
Autonomic effects I
Assessed 20 times on each study day via systolic and diastolic blood pressure
Measured: 18 months
Autonomic effects II
Assessed 20 times on each study day via heart rate
Measured: 18 months
Autonomic effects III
Assessed 20 times on each study day via tympanic body temperature
Measured: 18 months
Autonomic effects IV
Assessed 7 times on each study day via pupil diameter
Measured: 18 months
Autonomic effects V
Assessed one time on each study day via ECG (QT-time)
Measured: 18 months
Plasma levels of oxytocin
Assessed 5 times on each study day via blood samples
Measured: 18 months
Emotion processing I
Assessed one time on each study day via Face Emotion Recognition Task (FERT).
Measured: 18 months
Emotion processing II
Assessed one time on each study day via Multifaceted Empathy Test (MET).
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start1 Dec 2021
- Primary completion18 Jun 2024
- Study completion18 Jun 2024
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 four active substance conditions (equimolar doses of psychoactive substance) and placebo: 1\. MDMA (100 mg MDMA-hydrochloride; 84.1 mg MDMA free base) 2) MDA (93.9 mg MDA-hydrochloride; 78.0 mg MDA free base) 3) lysMDMA (171.7mg lysMDMA dihydrochloride; 84.1 mg MDMA free base) 4) lysMDA (165.6 mg lysMDA dihydrochloride; 78.0 mg MDA free base) 5) Placebo
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 23 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, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04847206
- Sponsor's protocol ID
- BASEC 2021-00405
- Acronym
- MDMA-like
- Status last verified
- Aug 2024
- First submitted
- 1 Apr 2021
- Last updated
- 14 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Straumann I, Vizeli P, Avedisian I, Erne L, Noorshams D, Vukalovic I, Eckert A, Luethi D, Rudin D, Liechti ME. Acute effects of MDMA, MDA, lysine-MDMA, and lysine-MDA in a randomized, double-blind, placebo-controlled, crossover trial in healthy participants. Neuropsychopharmacology. 2026 Jan;51(2):476-485. doi: 10.1038/s41386-025-02248-3. Epub 2025 Sep 25.
PubMed 40999236
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of MDMA-like Substances in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04847206
- Acronym / sponsor ID
- MDMA-like / BASEC 2021-00405
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 18 Jun 2024 (actual)
- Study completion
- 18 Jun 2024 (actual)
- First posted
- 19 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.
The serotonin (5-HT) and oxytocin releaser and so-called "empathogen" 3,4-methylenedioxymethamphetamine (MDMA) acutely produces positive feelings, empathy, and trust. MDMA is used recreationally (ecstasy), as research tool to study 5-HT and oxytocin function, and is investigated for MDMA-assisted psychotherapy.
MDMA is metabolized in part (10%) to the psychoactive metabolite 3,4-methylenedioxyamphetamine (MDA) which itself is also a recreational substance and has also been used to assist psychotherapy in the past. The present study aims to describe and directly compare for the first time the effects of MDMA and MDA in the same healthy volunteers and using modern psychological and psychometric tests.
Additionally, although amphetamines including MDMA and MDA induce mainly positive subjective effects they may also produce negative subjective drug effects including anxiety in particular at the onset of the subjective response and the rapid onset of euphoria may increase the risk of abuse. Additionally, blood pressure may increase rapidly at drug onset. A possible solution to mitigate anxiety, abuse-related rapid euphoria increases and/or rapid blood pressure changes at onset consist of slowing the onset of the drug effect by using a slow-release formulation of MDMA. In the present study, the investigators will characterize the effects of lysine-MDMA and lysine-MDA and compare their effects with MDMA/MDA to test the concept of attenuated effects across both substances.
Detailed description
3,4-methylenedioxymethamphetamine (MDMA) is used as recreational substance (Ecstasy), research tool to stimulate serotonin (5-HT) and oxytocin release and study associated mood states, and as a potential therapeutic substance to enhance psychotherapy for post-traumatic stress disorder. MDMA is an amphetamine derivative which, unlike prototypical amphetamines, predominantly enhances serotonergic neurotransmission via release of 5-HT through the SERT and it less potently also releases dopamine and norepinephrine through the DA transporter and NE transporter, respectively. Furthermore, MDMA is known to trigger oxytocin release which may contribute to its effects to increase trust, prosociality, and enhance empathy. MDMA is therefore referred to as an "entactogen" or "empathogen". MDMA is currently the only empathogen investigated in substance-assisted psychotherapy but other substances including the MDMA-metabolite 3,4-methylenedioxyamphetamine (MDA) have been used in the past or may be used in the future.
Aim 1: MDA may exert greater perceptual psychedelic-like effects due to a more potent binding to the serotonin 5-HT2A receptor, and it may also act longer than MDMA partly due to a longer plasma half-life. However, effects of MDMA and MDA have never been compared directly in the same study in humans and there is only one modern study that characterized MDA in humans. Therefore, the present study aims to describe and directly compare for the first time the effects of MDMA and MDA in the same healthy volunteers using modern and sensitive psychological and psychometric tests.
Aim 2: Additionally, although amphetamines including MDMA and MDA induce mainly positive subjective effects they may also produce negative subjective drug effects including anxiety in particular at the onset of the subjective response and the rapid onset of euphoria may increase abuse liability. Additionally, blood pressure may increase rapidly at drug onset. A possible solution to mitigate anxiety, abuse-related rapid euphoria increases and/or rapid blood pressure changes at onset consist of slowing the onset of the drug effect by using a slow-release formulation of MDMA/MDA. Alternatively, amphetamines can be linked to the endogenous amino acid lysine forming inactive lysine-amphetamine which then liberates the active amphetamine slowly in the circulation via plasma peptidases. This approach has been implemented with the medication Lisdexamfetamine, which combines lysine with d-amphetamine. In the present study, the investigators will similarly characterize the effects of lysine-MDMA and lysine-MDA to test for attenuated effects across both substances in comparison with MDMA/MDA.
Using a two-factorial study design with four active substance conditions (MDMA vs. MDA and lysine-MDMA vs. lysine-MDA) the investigators will be able to test differences between MDMA and MDA (with and without lysine) as well as between lysinated a non-lysinated substance (regardless of active substance) in the same study and with high statistical power and within one study addressing two aims.
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 four active substance conditions (equimolar doses of psychoactive substance) and placebo: 1. MDMA (100 mg MDMA-hydrochloride; 84.1 mg MDMA free base) 2) MDA (93.9 mg MDA-hydrochloride; 78.0 mg MDA free base) 3) lysMDMA (171.7mg lysMDMA dihydrochloride; 84.1 mg MDMA free base) 4) lysMDA (165.6 mg lysMDA dihydrochloride; 78.0 mg MDA free base) 5) Placebo
| Arm | Type | Receives |
|---|---|---|
| MDMA (100 mg MDMA-hydrochloride) | Experimental | Drug: 3,4-methylenedioxymethamphetamineMDMA (100 mg MDMA-hydrochloride; 84.1 mg MDMA free base) |
| MDA (93.9 mg MDA-hydrochloride) | Experimental | Drug: 3,4-methylenedioxyamphetamineMDA (93.9 mg MDA-hydrochloride; 78.0 mg MDA free base) |
| lysine-MDMA (171.7mg lysMDMA dihydrochloride | Experimental | Drug: lysine-3,4-methylenedioxymethamphetaminelysine-MDMA (171.7mg lysMDMA dihydrochloride; 84.1 mg MDMA free base) |
| lysine-MDA (165.6 mg lysMDA dihydrochloride; | Experimental | Drug: lysine-3,4-methylenedioxyamphetaminelysine-MDA (165.6 mg lysMDA dihydrochloride; 78.0 mg MDA free base) |
| Placebo | Placebo comparator | Other: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age between 18 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 or MDMA use more than 20 times or use of any illicit substance within the previous two months (not including cannabis)
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 |
|---|---|---|
| 3,4-methylenedioxymethamphetamineAlso: MDMAA moderate dose of 100 mg MDMA will be administered. | Drug | MDMA (100 mg MDMA-hydrochloride) |
| 3,4-methylenedioxyamphetamineAlso: MDAA moderate dose of 93.9 mg MDA will be administered. | Drug | MDA (93.9 mg MDA-hydrochloride) |
| lysine-3,4-methylenedioxymethamphetamineAlso: lysine-MDMAA moderate dose of 171.7 mg lysine-MDMA will be administered. | Drug | lysine-MDMA (171.7mg lysMDMA dihydrochloride |
| lysine-3,4-methylenedioxyamphetamineAlso: lysine-MDAA moderate dose of 165.6 mg lysine-MDA will be administered. | Drug | lysine-MDA (165.6 mg lysMDA dihydrochloride; |
| PlaceboPlacebo (Mannitol) | Other | Placebo |
Primary outcome
Acute subjective effects I
Time frame: 18 months
Visual Analog Scales (VAS) assessing the intensity and duration of subjective effects on a scale from 0 - 100 percent with higher scores representing more intense effects
Plasma levels of MDMA
Time frame: 18 months
Assessed 18 times on each study day via blood samples
Plasma levels of MDA
Time frame: 18 months
Assessed 18 times on each study day via blood samples
17 secondary outcomes
Acute Subjective effects II
Time frame: 18 months
Acute Subjective effects III
Time frame: 18 months
States of Consciousness Questionnaire
Time frame: 18 months
Psychological Insight Questionnaire
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
Autonomic effects IV
Time frame: 18 months
Autonomic effects V
Time frame: 18 months
Plasma levels of oxytocin
Time frame: 18 months
Emotion processing I
Time frame: 18 months
Emotion processing II
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
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 Aug 2024.
- Derived from this study: PubMed 40999236Straumann I, Vizeli P, Avedisian I, Erne L, Noorshams D, Vukalovic I, Eckert A, Luethi D, Rudin D, Liechti ME. Acute effects of MDMA, MDA, lysine-MDMA, and lysine-MDA in a randomized, double-blind, placebo-controlled, crossover trial in healthy participants. Neuropsychopharmacology. 2026 Jan;51(2):476-485. doi: 10.1038/s41386-025-02248-3. Epub 2025 Sep 25.
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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, 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 3,4-methylenedioxymethamphetamine, 3,4-methylenedioxyamphetamine and lysine-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 14 Aug 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?
Acute subjective effects I (time frame: 18 months). The study lists 3 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 NCT04847206, 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 Aug 2024.