Effects of Dimethyltryptamine in Healthy Subjects

NCT04353024 | Completed Phase 1 DMC

• 1 other identifier: BASEC 2020-00376
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

N,N-dimethyltryptamine (DMT) is a naturally-occurring psychedelic substance widely used in recreational and spiritual settings. DMT can be used as 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).Therefore, an intravenous administration regime including a bolus and maintenance perfusion has been proposed to induce a stable and prolonged DMT experience allowing to study the psychological and autonomic acute effects of DMT. This administration allows to induce and end an altered state safely and quickly. The goal of the present study is to experimentally test different intravenous DMT administration schedules to investigate the subjective and autonomic effects of DMT in healthy subjects.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Altered states of consciousness profile

  Assessed once on each study day via 5 Dimensions of Altered States of Consciousness (5D-ASC) scale consisting of 94 items to be rated on a visual analog scale (0-100 mm), with higher values indicating stronger effects

  150 minutes

• Subjective effect ratings over time

  Assessed 22 times on each study day via Subjective Effect Scale (SES), consisting of 4 questions to be rated on a Likert scale ranging from 1 to 10, with higher ratings indicating stronger effects

  150 minutes

Secondary Outcomes (16)

• Subjective mood ratings

  150 minutes

• Mystical-type experiences

  150 minutes

• Autonomic effects I

  150 minutes

• Autonomic effects II

  150 minutes

• Plasma levels of DMT

  150 minutes

Study Arms (5)

Placebo

PLACEBO COMPARATOR

Bolus of 0 mg DMT + perfusion of 0 mg/min DMT over 60 min, resulting in a total dose of 0 mg DMT.

Drug: Saline

Low dose

EXPERIMENTAL

Intravenous bolus of 0 mg DMT + perfusion of 0.6 mg/min DMT over 90 min, resulting in a total dose of 54 mg DMT.

Drug: Dimethyltryptamine (DMT); Drug: Saline

Low dose with bolus

EXPERIMENTAL

Intravenous bolus of 15 mg DMT + perfusion of 0.6 mg/min DMT over 90 min, resulting in a total dose of 69 mg DMT.

Drug: Dimethyltryptamine (DMT)

High dose

EXPERIMENTAL

Intravenous bolus of 0 mg DMT + perfusion of 1 mg/min DMT over 90 min, resulting in a total dose of 90 mg DMT.

Drug: Dimethyltryptamine (DMT); Drug: Saline

High dose with bolus

EXPERIMENTAL

Intravenous bolus of 25 mg DMT + perfusion of 1 mg/min DMT over 90 min, resulting in a total dose of 115 mg DMT.

Drug: Dimethyltryptamine (DMT)

Interventions

Dimethyltryptamine (DMT) DRUG

Intravenous DMT bolus and/or DMT maintenance perfusion over 90 min

High dose; High dose with bolus; Low dose; Low dose with bolus

Saline DRUG

Intravenous saline bolus and/or saline maintenance perfusion over 90 min

High dose; Low dose; Placebo

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
• 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)

University Hospital Basel

Basel, Basel-Stadt BS, 4031, Switzerland

Location

Related Publications (1)

• Vogt SB, Ley L, Erne L, Straumann I, Becker AM, Klaiber A, Holze F, Vandersmissen A, Mueller L, Duthaler U, Rudin D, Luethi D, Varghese N, Eckert A, Liechti ME. Acute effects of intravenous DMT in a randomized placebo-controlled study in healthy participants. Transl Psychiatry. 2023 May 23;13(1):172. doi: 10.1038/s41398-023-02477-4.

  PMID: 37221177 DERIVED

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 Officials

• Matthias E Liechti, Prof. Dr. MD

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Double-blind, placebo-controlled, 5-period cross-over design with 4 different doses of DMT and placebo

Study Record Dates

• First Submitted: April 6, 2020
• First Posted: April 20, 2020
• Study Start: June 18, 2021
• Primary Completion: August 29, 2022
• Study Completion: September 22, 2022
• Last Updated: October 12, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)