Clinical TrialHealthy VolunteersDMTKetaminePlaceboRecruiting

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

This randomised, triple-blind, placebo-controlled crossover trial (n=18) will investigate the acute analgesic (anti-pain) effects of N,N-dimethyltryptamine (DMT) on experimentally induced acute nociceptive pain, hyperalgesia, and allodynia in healthy participants.

Target Enrollment
18 participants
Study Type
Phase I interventional
Design
Randomized, triple Blind

Detailed Description

This is a randomized, counter-balanced three-period crossover in healthy volunteers comparing continuous IV DMT infusion, racemic ketamine infusion, and saline placebo using a validated electrical stimulation pain model to probe nociception, hyperalgesia and allodynia.

DMT is administered as a controllable continuous intravenous infusion (1.2 mg/min) allowing rapid adjustment and termination; ketamine (1.0 mg/min) serves as an active comparator and saline as placebo. Outcomes include acute pain intensity and secondary measures of pain sensitisation.

Study Protocol

Preparation

sessions

Dosing

3 sessions

Integration

sessions

Study Arms & Interventions

DMT infusion

experimental

Continuous intravenous infusion of DMT (controllable, short half-life) in a single session within a three-period crossover.

Interventions

  • DMT1.2 mg/min
    via IV• single infusion

    Continuous IV infusion at 1.2 mg/min; rapidly adaptable and terminable psychedelic state.

Ketamine infusion

active comparator

Racemic ketamine active comparator infusion in crossover.

Interventions

  • Ketamine1 mg/min
    via IV• single infusion

    Racemic ketamine infusion at 1.0 mg/min as positive control.

Placebo infusion

inactive

Saline placebo infusion in crossover.

Interventions

  • Placebo
    via IV• single infusion

    Saline infusion (placebo).

Participants

Ages
25 – 75
Sexes
Male & Female

Inclusion Criteria

  • 1. Age between 25 and 75 years old
  • 2. Sufficient understanding of the German language
  • 3. Understanding of procedures and risks associated with the study
  • 4. Willing to adhere to the protocol and signing of the consent form
  • 5. 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 50-90 kg

Exclusion Criteria

  • 1. Chronic or acute medical condition
  • 2. Current or previous major psychiatric disorder
  • 3. Psychotic disorder or bipolar disorder in first-degree relatives
  • 4. Hypertension (SBP>140/90 mmHg) or hypotension (SBP<85 mmHg)
  • 5. Hallucinogenic and/or dissociative substance use (not including cannabis) more than 15 times or any time within the previous two months
  • 6. Pregnancy or current breastfeeding
  • 7. Participation in another clinical trial (currently or within the last 30 days)
  • 8. Use of medication that may interfere with the effects of the study medication
  • 9. Tobacco smoking (>10 cigarettes/day)
  • 10. Consumption of alcoholic beverages (>20 drinks/week)

Study Details

  • Status
    Recruiting
  • Phase
    Phase I
  • Type
    interventional
  • Design
    Randomizedtriple Blind
  • Target Enrollment18 participants
  • Timeline
    Start: 2024-05-01
    End: 2025-02-28
  • Compounds
    DMTKetaminePlacebo
  • Topic
    Healthy Volunteers

Locations

Clinical Pharmacology & Toxicology, University Hospital Basel — Basel, Switzerland

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