HealhtyPhase 1MDPSNCT07494214
Acute Analgesic Effects of MDMA on Experimentally Induced Acute Pain, Hyperalgesia and Allodynia in Healthy Participants
A Phase 1 study testing MDMA 25 mg, MDMA 75 mg and MDMA 125 mg in people with Healhty, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
This study investigates whether MDMA may have a pain-reducing effect. The effect of MDMA is compared with a placebo (a substance with no active effect). In the study, moderate pain will be artificially created in healthy participants using repeated small electrical pulses applied under the skin. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healhty
- What is being tested?
- MDMA 25 mg, MDMA 75 mg and MDMA 125 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- 9 Mar 2026to 9 Apr 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age between 18 and 75 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
- Willing not to operate heavy machinery for 48 hours after the study session.
- Willing to use effective birth control throughout study participation
- Body mass index between 18-34.9 kg/m2
Who cannot join
- Relevant chronic or acute medical condition
- Any implanted medical devices (e.g., pacemakers, neurostimulators, or metal prostheses)
- Current or previous major psychiatric disorder (e.g. bipolar disorder, schizophrenia), current depression or anxiety disorder.
- Psychotic disorder or bipolar disorder in first-degree relatives
- Hypertension (SBP>140/90 mmHg) or hypotension (SBP<85 mmHg)
- Lifetime use of MDMA on more than 20 occasions or any use within the previous two months
Show all 11Show fewer
- Pregnancy or current breastfeeding
- 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 (>15 drinks/week)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Clinical Pharmacology & Toxicology, University Hospital Basel
Basel, 4056
Severin B Vogt, Dr. med., +41 61 268 68 66, severinbenjamin.vogt@usb.ch
Matthias E Liechti, Prof., +41 61 268 68 86, matthias.liechti@usb.ch
About this study
Official title: Acute Analgesic Effects of 3,4-methylenedioxymethamphetamine (MDMA) on Experimentally Induced Acute Nociceptive Pain, Hyperalgesia and Allodynia in Healthy Participants (MDPS-study)
This study investigates whether MDMA may have a pain-reducing effect. The effect of MDMA is compared with a placebo (a substance with no active effect).
In the study, moderate pain will be artificially created in healthy participants using repeated small electrical pulses applied under the skin. At the same time, participants will take MDMA or a placebo by mouth. This allows researchers to compare how MDMA affects the artificially created pain. A total of 20 healthy volunteers will take part in this study.
Read the detailed description
Preliminary evidence from case series and small clinical trials suggests that 3,4-methylenedioxymethamphetamine (MDMA) may be promising candidates for the treatment of chronic or neuropathic pain. Moreover, MDMA potently releases serotonin, noradrenalin and oxytocin, which are implicated in the modulation of pain. However, data from rigorously conducted and randomized clinical trials are lacking. Additionally, the potential acute analgesic properties of MDMA remain poorly characterized. For instance, it is unclear whether MDMA possesses acute antinociceptive effects or if it rather modulate secondary pain phenomena such as hyperalgesia, allodynia, and/or functional pain. Here, the investigators will employ a validated electrical stimulation model in healthy volunteers that produces acute nociceptive pain but also features of chronic pain such as hyperalgesia and allodynia. The model is established for the detailed assessment of the analgesic effect of known analgesics or new compounds. Thus, the investigators will evaluate the efficacy of MDMA on different pain qualities within this model. The analgesic efficacy of MDMA 125 mg will be compared to MDMA 75 mg, MDMA 25 mg and placebo.
- Conditions
- Healhty
- Being tested
- MDMA 25 mg, MDMA 75 mg, MDMA 125 mg, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MDMA 25 mgDrug
oral administration
MDMA 75 mgDrug
oral administration
MDMA 125 mgDrug
oral administration
PlaceboDrug
oral administration
| Study group | Role | What they receive |
|---|---|---|
| MDMA 25 mg | Experimental | Not described Receives: Drug: MDMA 25 mg |
| MDMA 75 mg | Experimental | Not described Receives: Drug: MDMA 75 mg |
| MDMA 125 mg | Experimental | Not described Receives: Drug: MDMA 125 mg |
| Placebo | Experimental | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
NRS
Difference of the cumulative NRS scores (area under the effect curves, AUECs) between the MDMA 125 mg and placebo condition.
Measured: Periprocedural
Secondary outcomes (4)
Hyperalgesia and Allodnyia
Difference of the cumulative areas of hyperalgesia and allodynia (AUECs) between the MDMA 125 mg, MDMA 75 mg, MDMA 25 mg and placebo condition.
Measured: Periprocedural
Subjective effects and NRS ratings
Correlation between subjective effect ratings on the VAS (AUEC) and NRS pain scores and areas of hyperalgesia and allodynia (AUEC).
Measured: Periprocedural
Endocrine effects
oxytocin and cortisol serum levels
Measured: Periprocedural
NRS dose-dependent effects
Difference of the cumulative NRS scores between the MDMA 125 mg, MDMA 75 mg, MDMA 25 mg and placebo condition.
Measured: Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start9 Mar 2026
- Primary completion9 Mar 2027 (estimated)
- Study completion9 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealhtyStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07494214
- Sponsor's protocol ID
- BASEC 2025-01212
- Acronym
- MDPS
- Status last verified
- Mar 2026
- First submitted
- 9 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Analgesic Effects of 3,4-methylenedioxymethamphetamine (MDMA) on Experimentally Induced Acute Nociceptive Pain, Hyperalgesia and Allodynia in Healthy Participants (MDPS-study)
- ClinicalTrials.gov ID
- NCT07494214
- Acronym / sponsor ID
- MDPS / BASEC 2025-01212
- Conditions
- Healhty
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 9 Mar 2026 (actual)
- Primary completion
- 9 Mar 2027 (estimated)
- Study completion
- 9 Apr 2027 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigates whether MDMA may have a pain-reducing effect. The effect of MDMA is compared with a placebo (a substance with no active effect).
In the study, moderate pain will be artificially created in healthy participants using repeated small electrical pulses applied under the skin. At the same time, participants will take MDMA or a placebo by mouth. This allows researchers to compare how MDMA affects the artificially created pain. A total of 20 healthy volunteers will take part in this study.
Detailed description
Preliminary evidence from case series and small clinical trials suggests that 3,4-methylenedioxymethamphetamine (MDMA) may be promising candidates for the treatment of chronic or neuropathic pain. Moreover, MDMA potently releases serotonin, noradrenalin and oxytocin, which are implicated in the modulation of pain. However, data from rigorously conducted and randomized clinical trials are lacking. Additionally, the potential acute analgesic properties of MDMA remain poorly characterized. For instance, it is unclear whether MDMA possesses acute antinociceptive effects or if it rather modulate secondary pain phenomena such as hyperalgesia, allodynia, and/or functional pain. Here, the investigators will employ a validated electrical stimulation model in healthy volunteers that produces acute nociceptive pain but also features of chronic pain such as hyperalgesia and allodynia. The model is established for the detailed assessment of the analgesic effect of known analgesics or new compounds. Thus, the investigators will evaluate the efficacy of MDMA on different pain qualities within this model. The analgesic efficacy of MDMA 125 mg will be compared to MDMA 75 mg, MDMA 25 mg and placebo.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| MDMA 25 mg | Experimental | Drug: MDMA 25 mg |
| MDMA 75 mg | Experimental | Drug: MDMA 75 mg |
| MDMA 125 mg | Experimental | Drug: MDMA 125 mg |
| Placebo | Experimental | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age between 18 and 75 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 (11 listed)
- Relevant chronic or acute medical condition
- Any implanted medical devices (e.g., pacemakers, neurostimulators, or metal prostheses)
- Current or previous major psychiatric disorder (e.g. bipolar disorder, schizophrenia), current depression or anxiety disorder.
- Psychotic disorder or bipolar disorder in first-degree relatives
- Hypertension (SBP>140/90 mmHg) or hypotension (SBP<85 mmHg)
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 |
|---|---|---|
| MDMA 25 mgoral administration | Drug | MDMA 25 mg |
| MDMA 75 mgoral administration | Drug | MDMA 75 mg |
| MDMA 125 mgoral administration | Drug | MDMA 125 mg |
| Placebooral administration | Drug | Placebo |
Primary outcome
NRS
Time frame: Periprocedural
Difference of the cumulative NRS scores (area under the effect curves, AUECs) between the MDMA 125 mg and placebo condition.
4 secondary outcomes
Hyperalgesia and Allodnyia
Time frame: Periprocedural
Subjective effects and NRS ratings
Time frame: Periprocedural
Endocrine effects
Time frame: Periprocedural
NRS dose-dependent effects
Time frame: Periprocedural
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
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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.
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 MDMA 25 mg, MDMA 75 mg and MDMA 125 mg in people with Healhty, 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 8 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 27 Mar 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Severin B Vogt, Dr. med. (+41 61 268 68 66, severinbenjamin.vogt@usb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NRS (time frame: Periprocedural). 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 27 Mar 2026.