Status:

COMPLETED

Effects of Dimethyltryptamine in Healthy Subjects

Lead Sponsor:

University Hospital, Basel, Switzerland

Conditions:

Healthy

Eligibility:

All Genders

25-65 years

Phase:

PHASE1

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...

Detailed Description

N,N-dimethyltryptamine (DMT) is a naturally-occurring psychedelic substance widely used in recreational and spiritual settings in the form of Ayahuasca. Similar to lysergic acid diethylamide (LSD) or ...

Eligibility Criteria

Inclusion

  • 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

  • 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)

Key Trial Info

Start Date :

June 18 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

September 22 2022

Estimated Enrollment :

31 Patients enrolled

Trial Details

Trial ID

NCT04353024

Start Date

June 18 2021

End Date

September 22 2022

Last Update

October 12 2022

Active Locations (1)

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Page 1 of 1 (1 locations)

1

University Hospital Basel

Basel, Basel-Stadt BS, Switzerland, 4031