Acute Dose-dependent Effects of DMT in Healthy Subjects

NCT05384678 | Completed Phase 1 DMC

• 1 other identifier: BASEC 2022-00378
• Study Type: interventional
• Target: 24
• 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 continuous intravenous DMT dose rates 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 (5D-ASC)

  5 Dimensions of Altered States of Consciousness (5D-ASC) consisting of 94 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. Assessed once on each study day

  12 months

• 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.

  12 months

Secondary Outcomes (14)

• States of consciousness questionnaire (SCQ)

  12 months

• Spiritual Realms Questionnaire

  12 months

• Blood pressure

  12 months

• heart rate

  12 months

• body temperature

  12 months

Study Arms (6)

DMT 0.6 mg/min

EXPERIMENTAL

Drug: N,N-Dimethyltryptamine (54 mg)

DMT 1.2 mg/min

EXPERIMENTAL

Drug: N,N-Dimethyltryptamine (108 mg)

DMT 1.8 mg/min

EXPERIMENTAL

Drug: N,N-Dimethyltryptamine (162 mg)

DMT 2.4 mg/min

EXPERIMENTAL

Drug: N,N-Dimethyltryptamine (216 mg)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

DMT 1.2 mg/min + dose titration

EXPERIMENTAL

Drug: N,N-Dimethyltryptamine (108 mg) + dose titration

Interventions

N,N-Dimethyltryptamine (54 mg) DRUG

A dose rate of 0.6 mg/min will be administered

DMT 0.6 mg/min

N,N-Dimethyltryptamine (108 mg) DRUG

A dose rate of 1.2 mg/min will be administered

DMT 1.2 mg/min

N,N-Dimethyltryptamine (162 mg) DRUG

A dose rate of 1.8 mg/min will be administered

DMT 1.8 mg/min

N,N-Dimethyltryptamine (216 mg) DRUG

A dose rate of 2.4 mg/min will be administered

DMT 2.4 mg/min

Placebo DRUG

A Placebo (saline infusion) will be administered.

Placebo

N,N-Dimethyltryptamine (108 mg) + dose titration DRUG

A dose rate of 1.2 mg/min will be administered with subsequent patient-guided dose titration

DMT 1.2 mg/min + dose titration

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)

Universtity Hospital Basel

Basel, 4056, Switzerland

Location

MeSH Terms

Interventions

N,N-Dimethyltryptamine

Intervention Hierarchy (Ancestors)

Tryptamines; Biogenic Monoamines; Biogenic Amines; Amines; Organic Chemicals; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Matthias E Liechti, MD

  University Hospital Basel, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

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: 5-period random order, placebo-controlled, double-blind cross-over study with four active substance conditions and placebo: 1. 0.6 mg/min, 2. 1.2 mg/min, 3. 1.8 mg/min, 4. 2.4 mg/min, 5. Placebo. Additionally, a patient-guided titration will be performed at the sixth and last session (not randomized).

Study Record Dates

• First Submitted: May 17, 2022
• First Posted: May 20, 2022
• Study Start: November 15, 2022
• Primary Completion: March 8, 2024
• Study Completion: March 13, 2024
• Last Updated: April 25, 2024

Record last verified: 2024-04

Locations

CH (1)