CompletedPhase 1DMT

Effects of Dimethyltryptamine in Healthy Subjects

Sponsored by University Hospital, Basel, Switzerland

NCT ID
NCT04353024
Target Enrollment
31 participants
Start Date
2021-06-18
Est. Completion
2022-09-22

About This Study

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 Studied

Healthy

Interventions

  • Dimethyltryptamine (DMT)
  • Saline

Eligibility

Age:25 Years - 65 Years
Healthy Volunteers:Yes
View full eligibility criteria
Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Study Locations (1)

University Hospital Basel
Basel, Basel-Stadt BS, Switzerland

This trial is not recruiting

This study has completed enrollment. Check back for results or find similar trials.

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Data Source
ClinicalTrials.gov

Last updated from source