Clinical TrialHealthy VolunteersDMTDMTDMTDMTPlaceboDMTDMTDMTDMTDMTPlaceboCompleted

Acute Dose-dependent Effects of DMT-bolus Applications in Healthy Subjects (DMT BDR-Study) (DMT BDR)

Randomized crossover, Phase I healthy volunteer study (n=36) testing IV DMT boluses (5–25 mg range, with placebo) to establish dose–response for subjective and autonomic effects.

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

Detailed Description

This randomized, crossover study in healthy volunteers uses intravenous DMT bolus doses (5, 10, 15, 20 mg; escalation arm includes 25 mg) and saline placebo to map dose–response relationships for subjective experience and autonomic effects.

Bolus applications are given as 45-second IV injections separated by one hour; outcomes include subjective ratings and physiological measures (blood pressure, heart rate, autonomic parameters).

Study Protocol

Preparation

sessions

Dosing

6 sessions

Integration

sessions

Study Arms & Interventions

Randomized

experimental

Randomized, counter-balanced within-subject arm: IV DMT boluses (5,10,15,20 mg) or placebo in random order, boluses separated by 1 h.

Interventions

  • DMT5 mg
    via IV• single dose• 1 doses total

    IV bolus over 45 s; sessions separated by 1 h.

  • DMT10 mg
    via IV• single dose• 1 doses total

    IV bolus over 45 s; sessions separated by 1 h.

  • DMT15 mg
    via IV• single dose• 1 doses total

    IV bolus over 45 s; sessions separated by 1 h.

  • DMT20 mg
    via IV• single dose• 1 doses total

    IV bolus over 45 s; sessions separated by 1 h.

  • Placebo
    via IV• single dose• 1 doses total

    Saline placebo IV bolus over 45 s.

Dose escalation

experimental

Placebo + escalating IV DMT boluses (5→10→15→20→25 mg) separated by 1 h, dose escalation order.

Interventions

  • DMT5 mg
    via IV• single dose• 1 doses total

    IV bolus over 45 s; sessions separated by 1 h.

  • DMT10 mg
    via IV• single dose• 1 doses total

    IV bolus over 45 s; sessions separated by 1 h.

  • DMT15 mg
    via IV• single dose• 1 doses total

    IV bolus over 45 s; sessions separated by 1 h.

  • DMT20 mg
    via IV• single dose• 1 doses total

    IV bolus over 45 s; sessions separated by 1 h.

  • DMT25 mg
    via IV• single dose• 1 doses total

    IV bolus over 45 s; escalation arm only.

  • Placebo
    via IV• single dose• 1 doses total

    Saline placebo IV bolus over 45 s.

Participants

Ages
25 – 65
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • 1. Age between 25 and 65 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. Abstaining from xanthine-based liquids from the evenings prior to the study sessions and during the sessions
  • 7. Willing not to operate heavy machinery within 6 h of DMT administration
  • 8. Willing to use double-barrier birth control throughout study participation
  • 9. Body mass index between 18-29 kg/m2.

Exclusion Criteria

  • Exclusion Criteria:
  • 1. Chronic or acute medical condition
  • 2. Current or previous major psychiatric disorder (e.g. psychotic disorders, mania / hypomania, anxiety disorders).
  • 3. Psychotic disorder or bipolar disorder in first-degree relatives
  • 4. Hypertension (SBP>140/90 mmHg) or hypotension (SBP<85 mmHg)
  • 5. Hallucinogenic substance use (not including cannabis) more than 20 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

Locations

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

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