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Completed

NCT Number: NCT05695495

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

N,N-dimethyltryptamine (DMT) is a psychoactive substance with similar effects such as LSD or psilocybin. However, DMT is less well characterized than the latter substances. The present study is a modern randomized cross-over trial, investigating different intravenous DMT boluses over a broad dose range. Thus, different doses will be tested and related to subjective and autonomic effects.

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Key information

Conditions

Healthy

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Pharmacology & Toxicology, University Hospital Basel

Basel, 4056, Switzerland

About this study

N,N-dimethyltryptamine (DMT) is a naturally-occurring psychedelic substance widely used in recreational and spiritual settings (Ayahuasca). DMT is considered a tool to induce an altered state of consciousness of interest in psychological and psychiatric research. DMT is rapidly metabolized by monoamine oxidase (MAO) A. Therefore, it is inactive when administered orally and has a very short duration of action when administered parenterally (<20 min). However, to date no clinical study has investigated dose-response effects over a broad range of different doses of DMT within the same patient. The aim of the present study is to experimentally test different intravenous DMT bolus doses over a broad dose range and investigate the related subjective and autonomic effects in order to establish a precise dose-response relationship of DMT in healthy subjects.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • Chronic or acute medical condition
  • Current or previous major psychiatric disorder (e.g. psychotic disorders, mania / hypomania, anxiety disorders).
  • 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)

Treatment and study plan

N,N-Dimethyltryptamine (5mg)

Drug

Intravenous bolus application over 45 seconds

N,N-Dimethyltryptamine (10mg)

Drug

Intravenous bolus application over 45 seconds

N,N-Dimethyltryptamine (15mg)

Drug

Intravenous bolus application over 45 seconds

N,N-Dimethyltryptamine (20mg)

Drug

Intravenous bolus application over 45 seconds

N,N-Dimethyltryptamine (25mg)

Drug

Intravenous bolus application over 45 seconds

Placebo (saline)

Drug

Intravenous bolus application over 45 seconds

Primary outcomes

  1. Altered states of consciousness profile (OAV)

    Time frame: Repeatedly 1 hour after each bolus application

    Altered states of consciousness profile (OAV) consisting of 42 items to be rated on a visual analog scale (0-100 mm), with higher values indicating stronger effects with higher scores representing more intense effects

  2. Subjective effect ratings over time

    Time frame: Repeatedly 1 hour after each bolus application

    Participants will be asked by the investigator to repeatedly rate their subjective effects verbally on a Likert scale from 0 to 10 for: "any drug effect", "good drug effect", "bad drug effect", and "fear". Ratings will be performed before and repeatedly after substance administration and will take approximately 30 sec complete.

Secondary outcomes

  1. Psychedelic experience questionnnaire (PEQ)

    Time frame: Repeatedly 1 hour after each bolus application

    Assesses the emergence and intensity of phenomenons occurring in altered states of consciousness on a 6-point Likert scale ranging from 0 ("not at all") to 5 ("extremely").

  2. Near death experience content scale (NDE-C)

    Time frame: Repeatedly 1 hour after each bolus application

    The Near-Death Experience Content (NDE-C) scale is a tool to assess dimensions of near-death experience on a Likert scale ranging from 0 ("not at all") to 4 ("extremely").

  3. Spiritual Realms Questionnaire (SRQ)

    Time frame: Once at the end of study day

    Assesses the spiritual phenomenons elicited by psychedelic substances through 11 main questions to be answered on a total of 65 sub-ordered 100mm visual analog scales once on each study day

  4. Blood pressure

    Time frame: Repeatedly in short intervals (2-10 minutes) after each bolus application

    Assessed multiple times on each study day via systolic and diastolic blood pressure

  5. Heart rate

    Time frame: Repeatedly in short intervals (2-10 minutes) after each bolus application

    Assessed multiple times on each study day.

  6. Plasma level DMT

    Time frame: Repeatedly in short intervals (2-10 minutes) after each bolus application

    Assessed multiple times on each study day.

  7. Urine recovery of DMT

    Time frame: Once at the end of study day

    Assessed once on each study day

  8. NEO-Five-Factor-Inventory (NEO-FFI)

    Time frame: Baseline

    The NEO-FFI is a self-description questionnaire with 60 items for the measurement of the "big five": neuroticism, extraversion, openness, agreeableness, and consciousness. It uses a 5-point Likert scale ranging from "completely disagree" to "fully agree.

  9. Saarbrücker Personality Questionnaire (SPF)

    Time frame: Baseline

    The SPF defines empathy as the "reactions of one individual to the observed experiences of another." It assesses 28- items on a 5-point Likert scale ranging from "Does not describe me well" to "Describes me very well". The measure has 4 subscales (Perspective Taking, Fantasy, Empathic Concern, Personal Distress) each made up of 7 different items.

  10. Elliot Humility Scale (EHS)

    Time frame: Baseline

    The Elliot Humility Scale (EHS) is a validated 13-item self-rating measure assessing four subscales, i.e. openness, self-forgetfulness, accurate self-assessment, and focus on others on a 5-point Likert scale ranging from "strongly disagree" to "strongly agree"

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

Acute Dose-dependent Effects of DMT-bolus Applications in Healthy Subjects: A Placebo-controlled Cross-over Study (DMT BDR-Study).

Acronym: DMT BDR

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 25, 2023
Registry last updated
Apr 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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