This interventional study, named PREDICT and conducted by Maastricht University, aims to comprehensively evaluate the acute and subacute effects of 2C-B compared to psilocybin and a placebo. The study involves assessing various cognitive, emotional, and behavioural outcomes, including acute dosing day performance, cognition, behaviour, fMRI, pharmacokinetics, subjective effects, and subacute behavioural changes.
The primary outcome measure is acute dosing day performance, assessed by the digit symbol substitution task. The study aims to develop an imaging-metabolomics machine learning algorithm to predict the risk profile of novel psychoactive substances (NPS) using point-of-care blood samples. Eligible participants, aged 18 to 40, with previous psychedelic substance experience, will be randomly assigned to receive oral 2C-B, oral psilocybin, or a non-active control in a crossover design. The trial involves three dosing days with follow-ups on day 2 and day 5, with a two-week washout period between administrations.
Trial Details
2C-B is a novel psychoactive substance (NPS) which is widely used among recreational drug users, serving as a template pro-drug for new drugs of abuse and sharing phenomenological similarities with well characterised compounds such as psilocybin and MDMA. The study intends to provide a comprehensive neuropsychopharmacological evaluation of 2C-B's acute and persisting effects versus psilocybin. The overarching goal is to develop an imaging-metabolomics machine learning algorithm, which can predict the risk-profile of NPS using point of care blood samples.NCT Number NL8813
Sponsors & Collaborators
Maastricht UniversityMaastricht University is host to the psychopharmacology department (Psychopharmacology in Maastricht) where various researchers are investigating the effects of psychedelics.
Papers
Assessment of the acute effects of 2C-B vs psilocybin on subjective experience, mood and cognitionThis double-blind study (n=22) compares the effect of 2C-B (20mg) and psilocybin (15mg). It finds that 2C-B elicited alterations in consciousness of a psychedelic nature but with a shorter duration of self-reported effects than psilocybin. The study categorised 2C-B (at least at that dose) as a subjectively "lighter" psychedelic.