Clinical TrialCompleted

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

Double-blind, parallel-group, placebo-controlled pilot RCT (J Psychopharmacol 2024; Gent EM, Bryan JW, Cleary MA, Clarke TI, Holmwood HD, Nassereddine RO, Salway C, Depla S, Statton S, Krecké J, Morgan CJ; Psychopharmacology and Addiction Research Centre, University of Exeter, UK; PMID 38863284). Participants: 28 adults with alcohol misuse problems randomly assigned 1:1. Intervention: a single dose of sublingual esketamine hydrochloride (AWKN002: 115.1 mg) vs vitamin C (placebo) in oral thin film format, combined with 2 weeks of daily mindfulness-based intervention (MBI). Primary outcomes: mindfulness engagement (physical and psychological), alcohol cravings and consumption. Secondary: mystical experiences, dissociative states. Paper states pre-registered but registry number not in PubMed DataBankList or CT.gov; likely ISRCTN or EudraCT (UK trial). PMCID PMC11179319.

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

Study Details

  • Status
    Completed
  • Type
    interventional
  • Design
    Randomizeddouble Blind
  • Target Enrollment28 participants
  • Timeline
    Start: 2021-01-01
    End: 2024-01-01

Related Publications

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

Published
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.

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