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NCT05695495
Acute Dose-dependent Effects of DMT-bolus Applications in Healthy Subjects (DMT BDR-Study)
Conditions: Healthy
Sex: All
Ages: 25 Years – 65 Years
Healthy volunteers: 1
Phase: PHASE1
Enrollment: 36
Sponsor: University Hospital, Basel, Switzerland
Location: Switzerland
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.
Eligibility Criteria
Inclusion Criteria:Age between 25 and 65 years oldSufficient understanding of the German languageUnderstanding of procedures and risks associated with the studyWilling to adhere to the protocol and signing of the consent formWilling to refrain from the consumption of illicit psychoactive substances during the studyAbstaining from xanthine-based liquids from the evenings prior to the study sessions and during the sessionsWilling not to operate heavy machinery within 6 h of DMT administrationWilling to use double-barrier birth control throughout study participationBody mass index between 18-29 kg/m2.Exclusion Criteria:Chronic or acute medical conditionCurrent or previous major psychiatric disorder (e.g.
psychotic disorders, mania / hypomania, anxiety disorders).Psychotic disorder or bipolar disorder in first-degree relativesHypertension (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 monthsPregnancy or current breastfeedingParticipation in another clinical trial (currently or within the last 30 days)Use of medication that may interfere with the effects of the study medicationTobacco smoking (>10 cigarettes/day)Consumption of alcoholic beverages (>20 drinks/week)
Source: ClinicalTrials.gov (NCT05695495). StuddyBuddy aggregates publicly available trial information.