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

NCT05695495 | Completed Phase 1 DMC

• 1 other identifier: BASEC 2022-01224
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Altered states of consciousness profile (OAV)

  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

  Repeatedly 1 hour after each bolus application

• Subjective effect ratings over time

  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.

  Repeatedly 1 hour after each bolus application

Secondary Outcomes (10)

• Psychedelic experience questionnnaire (PEQ)

  Repeatedly 1 hour after each bolus application

• Near death experience content scale (NDE-C)

  Repeatedly 1 hour after each bolus application

• Spiritual Realms Questionnaire (SRQ)

  Once at the end of study day

• Blood pressure

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

• Heart rate

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

Study Arms (2)

Randomized

EXPERIMENTAL

Subjects will be administered intravenous DMT in 4 different bolus doses or placebo in randomized, counter-balanced order. The bolus applications will be separated by one hour.

Drug: N,N-Dimethyltryptamine (5mg); Drug: N,N-Dimethyltryptamine (10mg); Drug: N,N-Dimethyltryptamine (15mg); Drug: N,N-Dimethyltryptamine (20mg); Drug: Placebo (saline)

Dose ecalation

EXPERIMENTAL

Subjects will be administered a placebo and a maximum of 5 DMT bolus doses in an escalating dose order. The bolus applications will be separated by one hour.

Drug: N,N-Dimethyltryptamine (5mg); Drug: N,N-Dimethyltryptamine (10mg); Drug: N,N-Dimethyltryptamine (15mg); Drug: N,N-Dimethyltryptamine (20mg); Drug: N,N-Dimethyltryptamine (25mg); Drug: Placebo (saline)

Interventions

N,N-Dimethyltryptamine (5mg) DRUG

Intravenous bolus application over 45 seconds

Dose ecalation; Randomized

N,N-Dimethyltryptamine (10mg) DRUG

Intravenous bolus application over 45 seconds

Dose ecalation; Randomized

N,N-Dimethyltryptamine (15mg) DRUG

Intravenous bolus application over 45 seconds

Dose ecalation; Randomized

N,N-Dimethyltryptamine (20mg) DRUG

Intravenous bolus application over 45 seconds

Dose ecalation; Randomized

N,N-Dimethyltryptamine (25mg) DRUG

Intravenous bolus application over 45 seconds

Dose ecalation

Placebo (saline) DRUG

Intravenous bolus application over 45 seconds

Dose ecalation; Randomized

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

Clinical Pharmacology & Toxicology, University Hospital Basel

Basel, 4056, Switzerland

Location

MeSH Terms

Interventions

N,N-Dimethyltryptamine; Sodium Chloride

Intervention Hierarchy (Ancestors)

Tryptamines; Biogenic Monoamines; Biogenic Amines; Amines; Organic Chemicals; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: In the randomized arm, subjects will be administered intravenous DMT in 4 different bolus doses (5, 10, 15, 20mg) or placebo in randomized, counter-balanced order. In the dose escalation arm, subjects will be administered a placebo and a maximum of 5 DMT bolus doses (5, 10, 15, 20, 25mg) in an escalating dose order. In both arms, the bolus applications will be separated by one hour.

Study Record Dates

• First Submitted: November 14, 2022
• First Posted: January 25, 2023
• Study Start: June 12, 2024
• Primary Completion: February 2, 2025
• Study Completion: March 4, 2025
• Last Updated: April 11, 2025

Record last verified: 2025-04

Locations

CH (1)