Acute Analgesic Effects of DMT on Experimentally Induced Pain in Healthy Participants

NCT06180759 | Completed Phase 1 DMC

• 1 other identifier: BASEC 2023-01813
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (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".

  During the infusion (55minutes)

Secondary Outcomes (11)

• Area of hyperalgesia and allodynia

  During the electrical stimulation (2 hours)

• NRS scores after infusion

  After stopping the infusion (65 minutes)

• Association of subjective effect ratings with pain scores

  During the electrical stimulation (2 hours)

• Sensory and affective pain scores

  Retrospective evaluation after the electrial stimulation at the end of each study session.

• Association of psychedelic and mystical-type effects with pain scores

  During the electrical stimulation (2 hours) and retrospective evaluation at the end of each study session.

Study Arms (3)

Intravenous infusion of DMT

EXPERIMENTAL

Participants will be administered intravenous DMT.

Drug: Intravenous infusion of DMT

Intravenous infusion of ketamine

ACTIVE COMPARATOR

Participants will be administered intravenous racemic ketamine.

Drug: Intravenous infusion of ketamine

Intravenous infusion of placebo

PLACEBO COMPARATOR

Participants will be administered intravenous lacebo (saline infusion).

Drug: Intravenous infusion of placebo

Interventions

Intravenous infusion of DMT DRUG

A dose rate of 1.2 mg/min will be administered

Intravenous infusion of DMT

Intravenous infusion of ketamine DRUG

A dose rate of 1.0 mg/min will be administered

Intravenous infusion of ketamine

Intravenous infusion of placebo DRUG

A Placebo (saline infusion) will be administered.

Intravenous infusion of placebo

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• \. Willing to use effective birth control throughout study participation 8. Body mass index between 18-29 kg/m2 and body weight within 50 - 90kg

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

Clinical Pharmacology & Toxicology, University Hospital Basel

Basel, Basel, 4056, Switzerland

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 20, 2023
• First Posted: December 22, 2023
• Study Start: January 23, 2025
• Primary Completion: September 29, 2025
• Study Completion: November 6, 2025
• Last Updated: April 2, 2026

Record last verified: 2025-01

Locations

CH (1)