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

Healthy Clinical Trial

— DMT BDR  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05695495
• Other study ID #: BASEC 2022-01224
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: March 15, 2024
• Est. completion date: January 30, 2025

Study information

• Verified date: November 2023
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 36
• Est. completion date: January 30, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Age between 25 and 65 years old

2. Sufficient understanding of the German language

3. Understanding of procedures and risks associated with the study

4. Willing to adhere to the protocol and signing of the consent form

5. Willing to refrain from the consumption of illicit psychoactive substances during the study

6. Abstaining from xanthine-based liquids from the evenings prior to the study sessions and during the sessions

7. Willing not to operate heavy machinery within 6 h of DMT administration

8. Willing to use double-barrier birth control throughout study participation

9. Body mass index between 18-29 kg/m2.

Exclusion Criteria:

1. Chronic or acute medical condition

2. Current or previous major psychiatric disorder (e.g. psychotic disorders, mania / hypomania, anxiety disorders).

3. Psychotic disorder or bipolar disorder in first-degree relatives

4. Hypertension (SBP>140/90 mmHg) or hypotension (SBP<85 mmHg)

5. Hallucinogenic substance use (not including cannabis) more than 20 times or any time within the previous two months

6. Pregnancy or current breastfeeding

7. Participation in another clinical trial (currently or within the last 30 days)

8. Use of medication that may interfere with the effects of the study medication

9. Tobacco smoking (>10 cigarettes/day)

10. Consumption of alcoholic beverages (>20 drinks/week)

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• N,N-Dimethyltryptamine (5mg)
Intravenous bolus application over 45 seconds
• N,N-Dimethyltryptamine (10mg)
Intravenous bolus application over 45 seconds
• N,N-Dimethyltryptamine (15mg)
Intravenous bolus application over 45 seconds
• N,N-Dimethyltryptamine (20mg)
Intravenous bolus application over 45 seconds
• N,N-Dimethyltryptamine (25mg)
Intravenous bolus application over 45 seconds
• Placebo (saline)
Intravenous bolus application over 45 seconds

Locations

Country	Name	City	State
Switzerland	Clinical Pharmacology & Toxicology, University Hospital Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Psychedelic experience questionnnaire (PEQ)	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").	Repeatedly 1 hour after each bolus application
Secondary	Near death experience content scale (NDE-C)	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").	Repeatedly 1 hour after each bolus application
Secondary	Spiritual Realms Questionnaire (SRQ)	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	Once at the end of study day
Secondary	Blood pressure	Assessed multiple times on each study day via systolic and diastolic blood pressure	Repeatedly in short intervals (2-10 minutes) after each bolus application
Secondary	Heart rate	Assessed multiple times on each study day.	Repeatedly in short intervals (2-10 minutes) after each bolus application
Secondary	Plasma level DMT	Assessed multiple times on each study day.	Repeatedly in short intervals (2-10 minutes) after each bolus application
Secondary	Urine recovery of DMT	Assessed once on each study day	Once at the end of study day
Secondary	NEO-Five-Factor-Inventory (NEO-FFI)	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.	Baseline
Secondary	Saarbrücker Personality Questionnaire (SPF)	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.	Baseline
Secondary	Elliot Humility Scale (EHS)	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"	Baseline