Clinical TrialHealthy VolunteersPlaceboDMTDMTDMTDMTCompleted

Effects of Dimethyltryptamine in Healthy Subjects

Double-blind, placebo-controlled 5-period crossover HV study (n=31) testing four intravenous DMT infusion schedules (total doses 0, 54, 69, 90, 115 mg) to characterise subjective and autonomic effects.

Target Enrollment
31 participants
Study Type
Phase I interventional
Design
Randomized, quadruple Blind

Detailed Description

This randomised, quadruple-blind, five-period crossover study in healthy volunteers compares four intravenous DMT administration schemes and placebo using a bolus and maintenance perfusion model to produce a stable, prolonged DMT experience.

Primary aims are to test dose–response relationships and to compare bolus-plus-perfusion versus perfusion-only schedules on pharmacokinetic, subjective and autonomic outcomes; safety and tolerability are systematically recorded.

Study Protocol

Preparation

sessions

Dosing

5 sessions
90 min each

Integration

sessions

Study Arms & Interventions

Placebo

inactive

Bolus of 0 mg DMT + perfusion of 0 mg/min DMT over 60 min (saline).

Interventions

  • Placebo0 mg
    via IV• single infusion• 1 doses total

    Saline bolus and 0 mg/min perfusion (placebo).

Low dose

experimental

Intravenous perfusion 0.6 mg/min over 90 min (no bolus).

Interventions

  • DMT54 mg
    via IV• single infusion• 1 doses total

    Bolus 0 mg + perfusion 0.6 mg/min over 90 min (total 54 mg).

Low + bolus

experimental

Bolus 15 mg + perfusion 0.6 mg/min over 90 min.

Interventions

  • DMT69 mg
    via IV• single infusion• 1 doses total

    Bolus 15 mg + perfusion 0.6 mg/min over 90 min (total 69 mg).

High dose

experimental

Intravenous perfusion 1 mg/min over 90 min (no bolus).

Interventions

  • DMT90 mg
    via IV• single infusion• 1 doses total

    Bolus 0 mg + perfusion 1 mg/min over 90 min (total 90 mg).

High + bolus

experimental

Bolus 25 mg + perfusion 1 mg/min over 90 min.

Interventions

  • DMT115 mg
    via IV• single infusion• 1 doses total

    Bolus 25 mg + perfusion 1 mg/min over 90 min (total 115 mg).

Participants

Ages
25 – 65
Sexes
Male & Female

Inclusion Criteria

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

Exclusion Criteria

  • Exclusion Criteria:
  • 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 substance use (not including cannabis) more than 20 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)

Study Details

  • Status
    Completed
  • Phase
    Phase I
  • Type
    interventional
  • Design
    Randomizedquadruple Blind
  • Target Enrollment31 participants
  • Timeline
    Start: 2021-07-01
    End: 2022-08-01
  • Compounds
    PlaceboDMTDMTDMTDMT
  • Topic
    Healthy Volunteers

Locations

University Hospital Basel — Basel, Basel-Stadt BS, Switzerland

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