HealthyPhase 1DPSNCT06180759
Acute Analgesic Effects of DMT on Experimentally Induced Pain in Healthy Participants
A Phase 1 study testing Intravenous infusion of DMT and Intravenous infusion of ketamine in people with Healthy, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
N,N-dimethyltryptamine (DMT) is a classical psychedelic with similar effects like LSD or psilocybin. Preliminary evidence from case series and small open-label trials suggests that psychedelics may be promising candidates for the treatment of several pain-related diseases such as chronic pain, migraine, cluster… Read more about this study
- Who is it for?
- Ages 25 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Intravenous infusion of DMT and Intravenous infusion of ketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteSwitzerland
- Study dates
- 23 Jan 2025to 6 Nov 2025
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age between 25 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 6. Willing not to operate heavy machinery for 24 hours after the study session.
- 7. Willing to use effective birth control throughout study participation 8. Body mass index between 18-29 kg/m2 and body weight within 50 - 90kg
Who cannot join
- Chronic or acute medical condition
- Current or previous major psychiatric disorder
- Psychotic disorder or bipolar disorder in first-degree relatives
- Hypertension (SBP>140/90 mmHg) or hypotension (SBP<85 mmHg)
- Hallucinogenic and/or dissociative substance use (not including cannabis) more than 15 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, Basel, 4056
About this study
Official title: Acute Analgesic Effects of DMT on Experimentally Induced Acute Nociceptive Pain, Hyperalgesia and Allodynia in Healthy Participants
N,N-dimethyltryptamine (DMT) is a classical psychedelic with similar effects like LSD or psilocybin. Preliminary evidence from case series and small open-label trials suggests that psychedelics may be promising candidates for the treatment of several pain-related diseases such as chronic pain, migraine, cluster headache or phantom limb pain. However, data from rigorously conducted and randomized clinical trials are lacking. Additionally, the potential acute analgesic properties of psychedelics remain poorly characterized. Therefore, the investigators will evaluate the efficacy of DMT on different pain qualities within a model of electrically induced pain in healthy participants. The analgesic effects will be compared to racemic ketamine (active control) and placebo within a cross-over design.
Read the detailed description
Preliminary evidence from case series and small open-label trials suggests that psychedelics may be promising candidates for the treatment of several pain-related diseases such as chronic pain, migraine, cluster headache or phantom limb pain. However, data from rigorously conducted and randomized clinical trials are lacking. Additionally, the potential acute analgesic properties of psychedelics remain poorly characterized. For instance, it is unclear whether psychedelics possess acute antinociceptive effects or if they 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 N,N-dimethyltryptamine (DMT), a classical and naturally-occurring psychedelic, on different pain qualities within this model. DMT differs from other classical psychedelics in its very short elimination half-life. Due to its rapid metabolization by monoaminoxidases (MAO), DMT is not orally bioavailable in the absence of MAO-inhibitors and thus has to be administered continuously and intravenously. Recently, the investigators tested several continuous intravenous administration regimes of DMT that lead to the induction of a constant and rapidly adaptable psychedelic state. The regime allows to induce stable DMT effect that can be terminated rapidly. Due to this controllability, a continuous infusion of intravenous DMT is most suitable to assess time and concentration-dependent analgesic effects within the used pain model. The analgesic efficacy of DMT will be compared to ketamine, a known analgesic (positive control), and placebo.
- Conditions
- Healthy
- Being tested
- Intravenous infusion of DMT, Intravenous infusion of ketamine, Intravenous infusion of placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous infusion of DMTDrug
A dose rate of 1.2 mg/min will be administered
Intravenous infusion of ketamineDrug
A dose rate of 1.0 mg/min will be administered
Intravenous infusion of placeboDrug
A Placebo (saline infusion) will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Intravenous infusion of DMT | Experimental | Participants will be administered intravenous DMT. Receives: Drug: Intravenous infusion of DMT |
| Intravenous infusion of ketamine | Active comparator | Participants will be administered intravenous racemic ketamine. Receives: Drug: Intravenous infusion of ketamine |
| Intravenous infusion of placebo | Placebo comparator | Participants will be administered intravenous lacebo (saline infusion). Receives: Drug: Intravenous infusion of placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric rating scale (NRS) scores (0 - 10)
Difference of the cumulative NRS scores (area under the effect curves (AUECs)) between the DMT, ketamine (active-control) and placebo condition. NRS 0 represents "no pain at all" whereas 10 represents "the worst pain ever possible".
Measured: During the infusion (55minutes)
Secondary outcomes (11)
Area of hyperalgesia and allodynia
Difference of the cumulative areas of hyperalgesia and allodynia (Area under the effect curves (AUECs), in square centimeters * minutes) between the DMT, ketamine and placebo condition.
Measured: During the electrical stimulation (2 hours)
NRS scores after infusion
Difference of the cumulative NRS scores (Area under the effect curves (AUECs)) between the DMT, ketamine and placebo condition
Measured: After stopping the infusion (65 minutes)
Association of subjective effect ratings with pain scores
Assessment of the correlation between subjective effect ratings and NRS pain scores, areas of hyperalgesia and allodynia. Subjective effects are measured on the subjective effects scale (SES) that ranges from 0 ( = no effects) to 10 ( = most extreme effects).
Measured: During the electrical stimulation (2 hours)
Sensory and affective pain scores
Difference of retrospectively evaluated sensory and affective pain scores (Short version of the McGill Pain Questionnaire, SF-MPQ-D) between the DMT, ketamine and placebo condition. The SF-MPQ-D is scored from 0 (= no pain) to 3 (= strongest possible pain).
Measured: Retrospective evaluation after the electrial stimulation at the end of each study session.
Association of psychedelic and mystical-type effects with pain scores
Correlation between psychedelic and mystical-type effects (Five Dimensional Altered states of consciousness (5D-ASC), States of Consciousness Questionnaire (SCQ)) with NRS pain scores and areas of hyperalgesia and allodynia.
Measured: During the electrical stimulation (2 hours) and retrospective evaluation at the end of each study session.
Plasma levels of DMT and ketamine
Plasma levels of DMT and ketamine over time
Measured: During the electrical stimulation (2 hours)
Association of the intensity of electrical currents with NRS pain scores
Association of the intensity of electrical currents (in mA) that induced a target baseline pain score (NRS) of 6/10 with NRS pain scores and areas of hyperalgesia and allodynia.
Measured: During the electrical stimulation (2 hours)
Psychometric comparison between DMT, ketamine and placebo
Comparison of subjective effects, altered state of consciousness and mystical effect scores between DMT, ketamine, and placebo.
Measured: During the electrical stimulation (2 hours) and retrospective evaluation at the end of each study session.
Effect modulation through personality traits
Effect modulation through personality traits (NEO-Five Factor Inventary (NEO-FFI), Saarbrücken Persönlichkeitsfragebogen (SPF), Elliots humility scale (EHS), Defense-style questionnaire-40 (DSQ-40), Connor-Davidson Resilience Scale (CD-RISC), Five Facet Mindfulness Scale (FFMQ), ABC Connectedness to Nature Scale, (ABC-CNS)).
Measured: During the electrical stimulation (2 hours) and retrospective evaluation at the end of each study session.
Modulation of personality traits by acute subjective effects
Modulation of personality traits resilience (Connor-Davidson Resilience Scale, CD-RISC), mindfulness (Five Facet Mindfulness Questionnaire (FFMQ) and connectedness to nature (ABC-CNS) in association with acute subjective effects (Subjective Effects Scale (SES)) and psychedelic/mystical-type effects (Five Dimensional Altered States of consciousness Scale (5D-ASC), States of Consciousness Questionnaire (SCQ).
Measured: During the electrical stimulation (2 hours) and retrospective evaluation at the end of each study session.
Autonomic effects
Autonomic effects over time (blood pressure in mmHg, heart rate in beats per minute)
Measured: During the electrical stimulation (2 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2023
- Study start23 Jan 2025
- Primary completion29 Sep 2025
- Study completion6 Nov 2025
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
- On 3 separate days, participants will be administered DMT, ketamine or placebo in a randomized, counter-balanced order. Their effect on experimentally induced acute pain will be evaluated and compared.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 17 participants (actual)
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
- NCT06180759
- Sponsor's protocol ID
- BASEC 2023-01813
- Acronym
- DPS
- Status last verified
- Jan 2025
- First submitted
- 20 Nov 2023
- Last updated
- 2 Apr 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 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Analgesic Effects of DMT on Experimentally Induced Acute Nociceptive Pain, Hyperalgesia and Allodynia in Healthy Participants
- ClinicalTrials.gov ID
- NCT06180759
- Acronym / sponsor ID
- DPS / BASEC 2023-01813
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 23 Jan 2025 (actual)
- Primary completion
- 29 Sep 2025 (actual)
- Study completion
- 6 Nov 2025 (actual)
- First posted
- 22 Dec 2023 (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.
N,N-dimethyltryptamine (DMT) is a classical psychedelic with similar effects like LSD or psilocybin. Preliminary evidence from case series and small open-label trials suggests that psychedelics may be promising candidates for the treatment of several pain-related diseases such as chronic pain, migraine, cluster headache or phantom limb pain. However, data from rigorously conducted and randomized clinical trials are lacking. Additionally, the potential acute analgesic properties of psychedelics remain poorly characterized. Therefore, the investigators will evaluate the efficacy of DMT on different pain qualities within a model of electrically induced pain in healthy participants. The analgesic effects will be compared to racemic ketamine (active control) and placebo within a cross-over design.
Detailed description
Preliminary evidence from case series and small open-label trials suggests that psychedelics may be promising candidates for the treatment of several pain-related diseases such as chronic pain, migraine, cluster headache or phantom limb pain. However, data from rigorously conducted and randomized clinical trials are lacking. Additionally, the potential acute analgesic properties of psychedelics remain poorly characterized. For instance, it is unclear whether psychedelics possess acute antinociceptive effects or if they 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 N,N-dimethyltryptamine (DMT), a classical and naturally-occurring psychedelic, on different pain qualities within this model. DMT differs from other classical psychedelics in its very short elimination half-life. Due to its rapid metabolization by monoaminoxidases (MAO), DMT is not orally bioavailable in the absence of MAO-inhibitors and thus has to be administered continuously and intravenously. Recently, the investigators tested several continuous intravenous administration regimes of DMT that lead to the induction of a constant and rapidly adaptable psychedelic state. The regime allows to induce stable DMT effect that can be terminated rapidly. Due to this controllability, a continuous infusion of intravenous DMT is most suitable to assess time and concentration-dependent analgesic effects within the used pain model. The analgesic efficacy of DMT will be compared to ketamine, a known analgesic (positive control), and placebo.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- On 3 separate days, participants will be administered DMT, ketamine or placebo in a randomized, counter-balanced order. Their effect on experimentally induced acute pain will be evaluated and compared.
| Arm | Type | Receives |
|---|---|---|
| Intravenous infusion of DMT | Experimental | Drug: Intravenous infusion of DMTParticipants will be administered intravenous DMT. |
| Intravenous infusion of ketamine | Active comparator | Drug: Intravenous infusion of ketamineParticipants will be administered intravenous racemic ketamine. |
| Intravenous infusion of placebo | Placebo comparator | Drug: Intravenous infusion of placeboParticipants will be administered intravenous lacebo (saline infusion). |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age between 25 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 6. Willing not to operate heavy machinery for 24 hours after the study session.
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 (SBP>140/90 mmHg) or hypotension (SBP<85 mmHg)
- Hallucinogenic and/or dissociative substance use (not including cannabis) more than 15 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 |
|---|---|---|
| Intravenous infusion of DMTA dose rate of 1.2 mg/min will be administered | Drug | Intravenous infusion of DMT |
| Intravenous infusion of ketamineA dose rate of 1.0 mg/min will be administered | Drug | Intravenous infusion of ketamine |
| Intravenous infusion of placeboA Placebo (saline infusion) will be administered. | Drug | Intravenous infusion of placebo |
Primary outcome
Numeric rating scale (NRS) scores (0 - 10)
Time frame: During the infusion (55minutes)
Difference of the cumulative NRS scores (area under the effect curves (AUECs)) between the DMT, ketamine (active-control) and placebo condition. NRS 0 represents "no pain at all" whereas 10 represents "the worst pain ever possible".
11 secondary outcomes
Area of hyperalgesia and allodynia
Time frame: During the electrical stimulation (2 hours)
NRS scores after infusion
Time frame: After stopping the infusion (65 minutes)
Association of subjective effect ratings with pain scores
Time frame: During the electrical stimulation (2 hours)
Sensory and affective pain scores
Time frame: Retrospective evaluation after the electrial stimulation at the end of each study session.
Association of psychedelic and mystical-type effects with pain scores
Time frame: During the electrical stimulation (2 hours) and retrospective evaluation at the end of each study session.
Plasma levels of DMT and ketamine
Time frame: During the electrical stimulation (2 hours)
Association of the intensity of electrical currents with NRS pain scores
Time frame: During the electrical stimulation (2 hours)
Psychometric comparison between DMT, ketamine and placebo
Time frame: During the electrical stimulation (2 hours) and retrospective evaluation at the end of each study session.
Effect modulation through personality traits
Time frame: During the electrical stimulation (2 hours) and retrospective evaluation at the end of each study session.
Modulation of personality traits by acute subjective effects
Time frame: During the electrical stimulation (2 hours) and retrospective evaluation at the end of each study session.
Autonomic effects
Time frame: During the electrical stimulation (2 hours)
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 2 Apr 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Intravenous infusion of DMT and Intravenous infusion of ketamine 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 6 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 2 Apr 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?
Numeric rating scale (NRS) scores (0 - 10) (time frame: During the infusion (55minutes)). 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 2 Apr 2026; AzTrials last refreshed its copy on 8 Nov 2026.