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.
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.
IV DMT (25 mg) combined with alcohol memory reactivation procedure.
25 mg N,N‑DMT fumarate in 10 ml (2.5 mg/ml) infused over 10 minutes.
IV DMT (25 mg) combined with control memory reactivation.
25 mg DMT fumarate in 10 ml infused over 10 minutes.
IV placebo buffer with alcohol memory reactivation.
10 ml buffer placebo infused over 10 minutes.
IV placebo buffer with control memory reactivation.
10 ml buffer placebo infused over 10 minutes.