This unregistered trial (n=28) was a double-blind, placebo-controlled pilot RCT of esketamine combined with mindfulness-based intervention for alcohol use disorder in adults, which found that esketamine enhanced psychological engagement and transiently reduced alcohol cravings.
This synthetic trial has been added to our database because a psychedelic paper (about a clinical trial) references this trial, but no (live) registration can be found.
The study investigated whether a single dose of sublingual esketamine (115.1 mg) could enhance engagement in a two-week mindfulness-based intervention (MBI) for individuals with alcohol use disorder. Participants were randomly assigned to receive either esketamine or a vitamin C placebo in an oral thin film format, both alongside the daily MBI programme.
Results indicated that esketamine increased psychological engagement with the mindfulness practice and was associated with transient decreases in alcohol cravings. Additionally, the esketamine group reported significantly greater mystical experiences and dissociative states compared to the placebo group.
Sublingual esketamine hydrochloride (AWKN002) combined with 2 weeks of daily mindfulness-based intervention (MBI)
Administered in the form of two oral thin film strips
Sublingual vitamin C combined with 2 weeks of daily mindfulness-based intervention (MBI)
Vitamin C in the form of two oral thin film strips