Acute Dose-dependent Effects of DMT in Healthy Subjects

NCT ID: NCT05384678

Last Updated: 2024-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-15
• Study Completion Date: 2024-03-13

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.

Detailed 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). In Ayahuasca, DMT is consumed together with harmala alkaloids that inhibit MAO to increase the oral bioavailablitity of DMT and to prolong its action after oral use. Alternatively, an intravenous administration regime including a bolus and maintenance perfusion has been proposed to induce a stable and prolonged DMT experience and is currently being investigated. 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 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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

DMT 0.6 mg/min

Group Type: EXPERIMENTAL

N,N-Dimethyltryptamine (54 mg)

Intervention Type: DRUG

A dose rate of 0.6 mg/min will be administered

DMT 1.2 mg/min

Group Type: EXPERIMENTAL

N,N-Dimethyltryptamine (108 mg)

Intervention Type: DRUG

A dose rate of 1.2 mg/min will be administered

DMT 1.8 mg/min

Group Type: EXPERIMENTAL

N,N-Dimethyltryptamine (162 mg)

Intervention Type: DRUG

A dose rate of 1.8 mg/min will be administered

DMT 2.4 mg/min

Group Type: EXPERIMENTAL

N,N-Dimethyltryptamine (216 mg)

Intervention Type: DRUG

A dose rate of 2.4 mg/min will be administered

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

A Placebo (saline infusion) will be administered.

DMT 1.2 mg/min + dose titration

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

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

Interventions

N,N-Dimethyltryptamine (54 mg)

A dose rate of 0.6 mg/min will be administered

Intervention Type: DRUG

N,N-Dimethyltryptamine (108 mg)

A dose rate of 1.2 mg/min will be administered

Intervention Type: DRUG

N,N-Dimethyltryptamine (162 mg)

A dose rate of 1.8 mg/min will be administered

Intervention Type: DRUG

N,N-Dimethyltryptamine (216 mg)

A dose rate of 2.4 mg/min will be administered

Intervention Type: DRUG

Placebo

A Placebo (saline infusion) will be administered.

Intervention Type: DRUG

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

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

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Matthias E Liechti, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Basel, Basel, Switzerland

Locations

Universtity Hospital Basel

Basel, , Switzerland

Countries

Switzerland

Other Identifiers

BASEC 2022-00378

Identifier Type: -

Identifier Source: org_study_id