Clinical TrialAlcohol Use Disorder (AUD)EsketaminePlaceboCompleted

Esketamine (AWKN002) Combined with Mindfulness-Based Intervention for Alcohol Use Disorder: A Double-Blind Pilot RCT (Gent 2024, University of Exeter)

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.

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Target Enrollment
28 participants
Study Type
Phase II interventional
Design
Randomized, double Blind

Detailed Description

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.

Study Arms & Interventions

Esketamine

experimental

Sublingual esketamine hydrochloride (AWKN002) combined with 2 weeks of daily mindfulness-based intervention (MBI)

Interventions

  • Esketamine115.1 mg
    via Sublingual• single dose• 1 doses total

    Administered in the form of two oral thin film strips

Placebo

placebo

Sublingual vitamin C combined with 2 weeks of daily mindfulness-based intervention (MBI)

Interventions

  • Placebo
    via sublingual• single dose• 1 doses total

    Vitamin C in the form of two oral thin film strips

Study Details

Locations

United Kingdom

Related Publications

Open AccessindividualPrimary

Esketamine combined with a mindfulness-based intervention for individuals with alcohol problems

In a double-blind, randomised pilot study of 28 people with alcohol problems, sublingual esketamine (115.1 mg) combined with two weeks of daily mindfulness-based intervention increased psychological engagement with the practice and produced transient reductions in alcohol craving versus placebo. Esketamine also elicited greater mystical and dissociative experiences, suggesting these altered states may underlie enhanced engagement and potential therapeutic benefit.

Published
Journal
Journal of Psychopharmacology
Authors
Gent, E. M., Bryan, J. W., Cleary, M. A., Clarke, T. I., Holmwood, H. D., Nassereddine, R. O., Salway, C., Depla, S., Statton, S., Krecké, J., Morgan, C. J.