Stroke
Conditions
Interventions
Part A
Single dose DMT or placebo infusion (bolus followed by 6-h infusion)
Part B
Three dosages DMT or placebo per week for two weeks (bolus followed by 6-h
infusion)
Sponsors
Algernon Pharmaceuticals
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Normotensive male or female volunteers, deemed healthy on the basis of a clinical history, physical examination, ECG, vital signs, and laboratory tests of blood and urine; agree to follow the contraception requirements of the trial; able to give fully informed written consent.
Exclusion criteria
Exclusion criteria: Positive tests for hepatitis B & C, HIV; severe adverse reaction to any drug; history of adverse (psychological) reaction to DMT or other serotonergic psychedelic drugs; drug or alcohol abuse; use of over-the-counter medication (with the exception of common analgesics, eg paracetamol [acetaminophen] or ibuprofen) or receipt of coronavirus disease 2019 (COVID 19) vaccination during the 7 days before the first dose of trial medication, or use of prescribed medication during the 14 days before first dose of trial medication, or monoamine oxidase inhibitors (MAOI) during the 30 days before the first dose of trial medication; participation in other clinical trials of unlicensed medicines, or loss of more than 400 mL blood, within the previous 90 days; vital signs outside the acceptable range; positive urine drug test; clinically relevant abnormal findings at the screening assessment; acute or chronic illness; significant suicide risk identified from the C SSRS, previous suicidal behaviour/ideation, or clinical assessment; clinically relevant abnormal medical history or concurrent medical condition (including psychotic or seizure disorders); close (first and second degree) relative with schizophrenia spectrum or other psychotic, bipolar or related disorder; persistent psychological effects following the previous use of psychedelics; possibility that volunteer will not cooperate; pre-menopausal women who are pregnant or lactating, or are sexually active and not using a reliable method of contraception.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability: Vital signs (heart rate, blood pressure, respiratory rate and temperature), 12-lead electrocardiograms (ECGs), physical examination, laboratory safety tests (haematology, clinical chemistry, coagulation, and urinalysis), local tolerability at infusion site, Columbia-Suicide Severity Rating Scale (C SSRS), occurrence of psychotic symptoms (BPRS), occurrence of central 5-HT toxicity (Hunters criteria + CPK)and adverse events (AEs). | — |
Secondary
| Measure | Time frame |
|---|---|
| PK: Cmax, tmax, AUClast, AUC0-t, AUCinf, %AUCextrap, t*, CL, Vss, Vz, MRTinf, and *z of DMT. | — |
Countries
Netherlands
Outcome results
None listed