This double-blind placebo-controlled trial aims to assess the effects of DMT on healthy participants who smoke (n=50).
5 groups of 10 participants will be administered DMT (0.12 – 2.1 mg/kg) intravenously (IV). Participants will stay at the study centre overnight and will have a follow-up visit 7-9 days after DMT administration.
The trial is sponsored by Entheon Biomedical and aims to pave the way for further studies into the possibilities of using DMT to treat smoking addiction.
Country Netherlands
Visit trial
Status
Recruiting
Results Published
No
Start date
08 January 2021
End date
01 January 2023
Chance of happening
100%
Phase
Phase I
Design
Blinded
Type
Interventional
Generation
First
Participants
50
Sex
All
Age
18- 99
Therapy
No
Trial Details
DMT is a drug that has been used for a very long time by different cultures to cause a so-called 'trip'. DMT is used in these cultures as a component of a drink, called Ayahuasca, made from plants. During such a trip, people often experience hallucinations (not limited to seeing and hearing things that are not there) and a change of thinking about themselves and the environment and therefore behaving differently than usual, a feeling of heaviness in the body, transient anxiety, and/or feeling intoxicated. Because of these effects, DMT is also called a hallucinogenic substance. DMT causes a trip by stimulating the place in the brain (receptor) where normally the messenger substance serotonin exerts its function. Serotonin is present in many different brain areas and has several functions. It plays an important role in the regulation of mood, sleep, perception, emotions, and memory. The increase in serotonin may cause people with psychiatric disorders to experience fewer complaints. Previous research has shown that hallucinogenic substances that increase serotonin, can be used in the treatment of anxiety, depression and nicotine addiction. Entheon Biomedical wants to investigate the medicinal product DMT, developed as part of a new nicotine addiction treatment.NCT Number
Sponsors & Collaborators
Entheon BiomedicalEntheon Biomedical is a listed (CSE) company that aims to develop DMT for addiction treatment.
Leiden University
Leiden University Medical Center is doing several studies into psychedelics. They do this in cooperation with other universities (e.g. Utrecht University) and companies (e.g. COMPASS).