Understanding Neuroplasticity Induced by TrYptamines (UNITy): the effects of dimethyltryptamine (DMT) on drinking
Randomised, double-blind, placebo-controlled 2×2 factorial mechanistic study (n=120) testing 25 mg IV DMT vs placebo combined with alcohol memory reactivation in non-treatment-seeking hazardous/harmful drinkers.
Details
A 2×2 factorial randomised, double-blind mechanistic trial evaluates 25 mg IV N,N‑DMT fumarate or placebo given as a single 10 ml infusion (10 minutes) crossed with an alcohol memory reactivation versus control memory procedure in non-treatment-seeking excessive drinkers.
Primary outcome is mean alcohol consumption (g EtOH/day) by TLFB at baseline and follow-ups; secondary measures include blood phosphatidylethanol, cue-reactivity fMRI, craving questionnaires and daily EMA of consumption and craving.
Neuroimaging and mechanistic biomarkers (fMRI cue reactivity, neural connectivity) and safety/tolerability are assessed with follow-ups to 36 weeks; anonymised data and code will be shared via open repositories.