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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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  • 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

Other trials in Switzerland

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 groups in NCT06180759
Study groupRoleWhat they receive
Intravenous infusion of DMTExperimentalParticipants will be administered intravenous DMT.
Receives: Drug: Intravenous infusion of DMT
Intravenous infusion of ketamineActive comparatorParticipants will be administered intravenous racemic ketamine.
Receives: Drug: Intravenous infusion of ketamine
Intravenous infusion of placeboPlacebo comparatorParticipants 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.

  1. 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)

  1. 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)

  2. 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)

  3. 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)

  4. 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.

  5. 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.

  6. Plasma levels of DMT and ketamine

    Plasma levels of DMT and ketamine over time

    Measured: During the electrical stimulation (2 hours)

  7. 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)

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  1. First posted22 Dec 2023
  2. Study start23 Jan 2025
  3. Primary completion29 Sep 2025
  4. Study completion6 Nov 2025

Resources

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)
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

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?

On the ClinicalTrials.gov record for NCT06180759.

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.

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