Clinical TrialHealthy VolunteersDMTDMTDMTDMTPlaceboDMTCompleted

Acute Dose-dependent Effects of DMT in Healthy Subjects: A Placebo-controlled Cross-over Study (DMT DR)

The present study is a modern randomized cross-over trial, investigating different continuous intravenous DMT dose rates over a broad dose range.

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

Detailed Description

Randomized, double-blind, placebo-controlled 5-period crossover in healthy volunteers (n=24) testing IV DMT at 0.6, 1.2, 1.8 and 2.4 mg/min with a placebo arm; a sixth session permits patient-guided titration.

Primary aim is to characterise dose–response relationships for subjective and autonomic effects using continuous IV infusion regimens and relate doses to acute safety and physiological measures.

Study Protocol

Preparation

sessions

Dosing

6 sessions

Integration

sessions

Study Arms & Interventions

DMT 0.6 mg/min

experimental

IV infusion of DMT at 0.6 mg/min (single session).

Interventions

  • DMT0.6 mg/min
    via IV• single dose• 1 doses total

    Total dose ~54 mg (infusion).

DMT 1.2 mg/min

experimental

IV infusion of DMT at 1.2 mg/min (single session).

Interventions

  • DMT1.2 mg/min
    via IV• single dose• 1 doses total

    Total dose ~108 mg (infusion).

DMT 1.8 mg/min

experimental

IV infusion of DMT at 1.8 mg/min (single session).

Interventions

  • DMT1.8 mg/min
    via IV• single dose• 1 doses total

    Total dose ~162 mg (infusion).

DMT 2.4 mg/min

experimental

IV infusion of DMT at 2.4 mg/min (single session).

Interventions

  • DMT2.4 mg/min
    via IV• single dose• 1 doses total

    Total dose ~216 mg (infusion).

Placebo

inactive

Saline infusion (placebo comparator).

Interventions

  • Placebo
    via IV• single dose• 1 doses total

    Saline infusion.

DMT 1.2 mg/min + titration

experimental

IV infusion at 1.2 mg/min with an additional patient-guided titration session.

Interventions

  • DMT1.2 mg/min
    via IV• single dose• 1 doses total

    Patient-guided dose titration in a sixth session; total dose ~108 mg before titration.

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

Universtity Hospital Basel — Basel, Switzerland

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