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Abstract

Objective:

Early evidence suggests that ketamine may be an effective treatment to sustain abstinence from alcohol. The authors investigated the safety and efficacy of ketamine compared with placebo in increasing abstinence in patients with alcohol use disorder. An additional aim was to pilot ketamine combined with mindfulness-based relapse prevention therapy compared with ketamine and alcohol education as a therapy control.

Methods:

In a double-blind placebo-controlled phase 2 clinical trial, 96 patients with severe alcohol use disorder were randomly assigned to one of four conditions: 1) three weekly ketamine infusions (0.8 mg/kg i.v. over 40 minutes) plus psychological therapy, 2) three saline infusions plus psychological therapy, 3) three ketamine infusions plus alcohol education, or 4) three saline infusions plus alcohol education. The primary outcomes were self-reported percentage of days abstinent and confirmed alcohol relapse at 6-month follow-up.

Results:

Ninety-six participants (35 women; mean age, 44.07 years [SD=10.59]) were included in the intention-to-treat analysis. The treatment was well tolerated, and no serious adverse events were associated with the study drug. Although confidence intervals were wide, consistent with a proof-of-concept study, there were a significantly greater number of days abstinent from alcohol in the ketamine group compared with the placebo group at 6-month follow-up (mean difference=10.1%, 95% CI=1.1, 19.0), with the greatest reduction in the ketamine plus therapy group compared with the saline plus education group (15.9%, 95% CI=3.8, 28.1). There was no significant difference in relapse rate between the ketamine and placebo groups.

Conclusions:

This study demonstrated that treatment with three infusions of ketamine was well tolerated in patients with alcohol use disorder and was associated with more days of abstinence from alcohol at 6-month follow-up. The findings suggest a possible beneficial effect of adding psychological therapy alongside ketamine treatment.

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Information & Authors

Information

Published In

Go to American Journal of Psychiatry
Go to American Journal of Psychiatry
American Journal of Psychiatry
Pages: 152 - 162
PubMed: 35012326

History

Received: 14 March 2021
Revision received: 18 June 2021
Revision received: 8 August 2021
Revision received: 28 September 2021
Accepted: 4 October 2021
Published online: 11 January 2022
Published in print: February 2022

Keywords

  1. Substance-Related and Addictive Disorders
  2. Alcohol
  3. Ketamine/Esketamine
  4. Psychotherapy

Authors

Details

Meryem Grabski, Ph.D.
Psychopharmacology and Addiction Research Centre (Grabski, McAndrew, Marsh, Raymen, Stevens, Hardy, Maschauer, Palmer, Mollaahmetoglu, Morgan) and College of Medicine and Health (Warren), University of Exeter, Exeter, U.K.; Clinical Psychopharmacology Unit (Grabski, Lawn, Marsh, Bloomfield, Borissova, Curran) and Translational Psychiatry Research Group (Bloomfield), University College London; Royal Devon and Exeter NHS Foundation Trust, Exeter, U.K. (Broomby, Price); University College London Hospitals NHS Foundation Trust, London (Coathup, Gilhooly, Gordon-Williams, Brandner); South London and Maudsley NHS Foundation Trust, London (Hill, Harris); Faculty of Medicine, Department of Brain Sciences, Imperial College London (Lingford-Hughes).
Amy McAndrew, Ph.D.
Psychopharmacology and Addiction Research Centre (Grabski, McAndrew, Marsh, Raymen, Stevens, Hardy, Maschauer, Palmer, Mollaahmetoglu, Morgan) and College of Medicine and Health (Warren), University of Exeter, Exeter, U.K.; Clinical Psychopharmacology Unit (Grabski, Lawn, Marsh, Bloomfield, Borissova, Curran) and Translational Psychiatry Research Group (Bloomfield), University College London; Royal Devon and Exeter NHS Foundation Trust, Exeter, U.K. (Broomby, Price); University College London Hospitals NHS Foundation Trust, London (Coathup, Gilhooly, Gordon-Williams, Brandner); South London and Maudsley NHS Foundation Trust, London (Hill, Harris); Faculty of Medicine, Department of Brain Sciences, Imperial College London (Lingford-Hughes).
Will Lawn, Ph.D.
Psychopharmacology and Addiction Research Centre (Grabski, McAndrew, Marsh, Raymen, Stevens, Hardy, Maschauer, Palmer, Mollaahmetoglu, Morgan) and College of Medicine and Health (Warren), University of Exeter, Exeter, U.K.; Clinical Psychopharmacology Unit (Grabski, Lawn, Marsh, Bloomfield, Borissova, Curran) and Translational Psychiatry Research Group (Bloomfield), University College London; Royal Devon and Exeter NHS Foundation Trust, Exeter, U.K. (Broomby, Price); University College London Hospitals NHS Foundation Trust, London (Coathup, Gilhooly, Gordon-Williams, Brandner); South London and Maudsley NHS Foundation Trust, London (Hill, Harris); Faculty of Medicine, Department of Brain Sciences, Imperial College London (Lingford-Hughes).
Beth Marsh, B.Sc.
Psychopharmacology and Addiction Research Centre (Grabski, McAndrew, Marsh, Raymen, Stevens, Hardy, Maschauer, Palmer, Mollaahmetoglu, Morgan) and College of Medicine and Health (Warren), University of Exeter, Exeter, U.K.; Clinical Psychopharmacology Unit (Grabski, Lawn, Marsh, Bloomfield, Borissova, Curran) and Translational Psychiatry Research Group (Bloomfield), University College London; Royal Devon and Exeter NHS Foundation Trust, Exeter, U.K. (Broomby, Price); University College London Hospitals NHS Foundation Trust, London (Coathup, Gilhooly, Gordon-Williams, Brandner); South London and Maudsley NHS Foundation Trust, London (Hill, Harris); Faculty of Medicine, Department of Brain Sciences, Imperial College London (Lingford-Hughes).
Laura Raymen, M.Sc.
Psychopharmacology and Addiction Research Centre (Grabski, McAndrew, Marsh, Raymen, Stevens, Hardy, Maschauer, Palmer, Mollaahmetoglu, Morgan) and College of Medicine and Health (Warren), University of Exeter, Exeter, U.K.; Clinical Psychopharmacology Unit (Grabski, Lawn, Marsh, Bloomfield, Borissova, Curran) and Translational Psychiatry Research Group (Bloomfield), University College London; Royal Devon and Exeter NHS Foundation Trust, Exeter, U.K. (Broomby, Price); University College London Hospitals NHS Foundation Trust, London (Coathup, Gilhooly, Gordon-Williams, Brandner); South London and Maudsley NHS Foundation Trust, London (Hill, Harris); Faculty of Medicine, Department of Brain Sciences, Imperial College London (Lingford-Hughes).
Tobias Stevens, Ph.D.
Psychopharmacology and Addiction Research Centre (Grabski, McAndrew, Marsh, Raymen, Stevens, Hardy, Maschauer, Palmer, Mollaahmetoglu, Morgan) and College of Medicine and Health (Warren), University of Exeter, Exeter, U.K.; Clinical Psychopharmacology Unit (Grabski, Lawn, Marsh, Bloomfield, Borissova, Curran) and Translational Psychiatry Research Group (Bloomfield), University College London; Royal Devon and Exeter NHS Foundation Trust, Exeter, U.K. (Broomby, Price); University College London Hospitals NHS Foundation Trust, London (Coathup, Gilhooly, Gordon-Williams, Brandner); South London and Maudsley NHS Foundation Trust, London (Hill, Harris); Faculty of Medicine, Department of Brain Sciences, Imperial College London (Lingford-Hughes).
Lorna Hardy, Ph.D.
Psychopharmacology and Addiction Research Centre (Grabski, McAndrew, Marsh, Raymen, Stevens, Hardy, Maschauer, Palmer, Mollaahmetoglu, Morgan) and College of Medicine and Health (Warren), University of Exeter, Exeter, U.K.; Clinical Psychopharmacology Unit (Grabski, Lawn, Marsh, Bloomfield, Borissova, Curran) and Translational Psychiatry Research Group (Bloomfield), University College London; Royal Devon and Exeter NHS Foundation Trust, Exeter, U.K. (Broomby, Price); University College London Hospitals NHS Foundation Trust, London (Coathup, Gilhooly, Gordon-Williams, Brandner); South London and Maudsley NHS Foundation Trust, London (Hill, Harris); Faculty of Medicine, Department of Brain Sciences, Imperial College London (Lingford-Hughes).
Fiona Warren, Ph.D.
Psychopharmacology and Addiction Research Centre (Grabski, McAndrew, Marsh, Raymen, Stevens, Hardy, Maschauer, Palmer, Mollaahmetoglu, Morgan) and College of Medicine and Health (Warren), University of Exeter, Exeter, U.K.; Clinical Psychopharmacology Unit (Grabski, Lawn, Marsh, Bloomfield, Borissova, Curran) and Translational Psychiatry Research Group (Bloomfield), University College London; Royal Devon and Exeter NHS Foundation Trust, Exeter, U.K. (Broomby, Price); University College London Hospitals NHS Foundation Trust, London (Coathup, Gilhooly, Gordon-Williams, Brandner); South London and Maudsley NHS Foundation Trust, London (Hill, Harris); Faculty of Medicine, Department of Brain Sciences, Imperial College London (Lingford-Hughes).
Michael Bloomfield, Ph.D.
Psychopharmacology and Addiction Research Centre (Grabski, McAndrew, Marsh, Raymen, Stevens, Hardy, Maschauer, Palmer, Mollaahmetoglu, Morgan) and College of Medicine and Health (Warren), University of Exeter, Exeter, U.K.; Clinical Psychopharmacology Unit (Grabski, Lawn, Marsh, Bloomfield, Borissova, Curran) and Translational Psychiatry Research Group (Bloomfield), University College London; Royal Devon and Exeter NHS Foundation Trust, Exeter, U.K. (Broomby, Price); University College London Hospitals NHS Foundation Trust, London (Coathup, Gilhooly, Gordon-Williams, Brandner); South London and Maudsley NHS Foundation Trust, London (Hill, Harris); Faculty of Medicine, Department of Brain Sciences, Imperial College London (Lingford-Hughes).
Anya Borissova, M.D.
Psychopharmacology and Addiction Research Centre (Grabski, McAndrew, Marsh, Raymen, Stevens, Hardy, Maschauer, Palmer, Mollaahmetoglu, Morgan) and College of Medicine and Health (Warren), University of Exeter, Exeter, U.K.; Clinical Psychopharmacology Unit (Grabski, Lawn, Marsh, Bloomfield, Borissova, Curran) and Translational Psychiatry Research Group (Bloomfield), University College London; Royal Devon and Exeter NHS Foundation Trust, Exeter, U.K. (Broomby, Price); University College London Hospitals NHS Foundation Trust, London (Coathup, Gilhooly, Gordon-Williams, Brandner); South London and Maudsley NHS Foundation Trust, London (Hill, Harris); Faculty of Medicine, Department of Brain Sciences, Imperial College London (Lingford-Hughes).
Emily Maschauer, M.Sc.
Psychopharmacology and Addiction Research Centre (Grabski, McAndrew, Marsh, Raymen, Stevens, Hardy, Maschauer, Palmer, Mollaahmetoglu, Morgan) and College of Medicine and Health (Warren), University of Exeter, Exeter, U.K.; Clinical Psychopharmacology Unit (Grabski, Lawn, Marsh, Bloomfield, Borissova, Curran) and Translational Psychiatry Research Group (Bloomfield), University College London; Royal Devon and Exeter NHS Foundation Trust, Exeter, U.K. (Broomby, Price); University College London Hospitals NHS Foundation Trust, London (Coathup, Gilhooly, Gordon-Williams, Brandner); South London and Maudsley NHS Foundation Trust, London (Hill, Harris); Faculty of Medicine, Department of Brain Sciences, Imperial College London (Lingford-Hughes).
Rupert Broomby, M.D.
Psychopharmacology and Addiction Research Centre (Grabski, McAndrew, Marsh, Raymen, Stevens, Hardy, Maschauer, Palmer, Mollaahmetoglu, Morgan) and College of Medicine and Health (Warren), University of Exeter, Exeter, U.K.; Clinical Psychopharmacology Unit (Grabski, Lawn, Marsh, Bloomfield, Borissova, Curran) and Translational Psychiatry Research Group (Bloomfield), University College London; Royal Devon and Exeter NHS Foundation Trust, Exeter, U.K. (Broomby, Price); University College London Hospitals NHS Foundation Trust, London (Coathup, Gilhooly, Gordon-Williams, Brandner); South London and Maudsley NHS Foundation Trust, London (Hill, Harris); Faculty of Medicine, Department of Brain Sciences, Imperial College London (Lingford-Hughes).
Robert Price, M.D.
Psychopharmacology and Addiction Research Centre (Grabski, McAndrew, Marsh, Raymen, Stevens, Hardy, Maschauer, Palmer, Mollaahmetoglu, Morgan) and College of Medicine and Health (Warren), University of Exeter, Exeter, U.K.; Clinical Psychopharmacology Unit (Grabski, Lawn, Marsh, Bloomfield, Borissova, Curran) and Translational Psychiatry Research Group (Bloomfield), University College London; Royal Devon and Exeter NHS Foundation Trust, Exeter, U.K. (Broomby, Price); University College London Hospitals NHS Foundation Trust, London (Coathup, Gilhooly, Gordon-Williams, Brandner); South London and Maudsley NHS Foundation Trust, London (Hill, Harris); Faculty of Medicine, Department of Brain Sciences, Imperial College London (Lingford-Hughes).
Rachel Coathup, M.D.
Psychopharmacology and Addiction Research Centre (Grabski, McAndrew, Marsh, Raymen, Stevens, Hardy, Maschauer, Palmer, Mollaahmetoglu, Morgan) and College of Medicine and Health (Warren), University of Exeter, Exeter, U.K.; Clinical Psychopharmacology Unit (Grabski, Lawn, Marsh, Bloomfield, Borissova, Curran) and Translational Psychiatry Research Group (Bloomfield), University College London; Royal Devon and Exeter NHS Foundation Trust, Exeter, U.K. (Broomby, Price); University College London Hospitals NHS Foundation Trust, London (Coathup, Gilhooly, Gordon-Williams, Brandner); South London and Maudsley NHS Foundation Trust, London (Hill, Harris); Faculty of Medicine, Department of Brain Sciences, Imperial College London (Lingford-Hughes).
David Gilhooly, M.D.
Psychopharmacology and Addiction Research Centre (Grabski, McAndrew, Marsh, Raymen, Stevens, Hardy, Maschauer, Palmer, Mollaahmetoglu, Morgan) and College of Medicine and Health (Warren), University of Exeter, Exeter, U.K.; Clinical Psychopharmacology Unit (Grabski, Lawn, Marsh, Bloomfield, Borissova, Curran) and Translational Psychiatry Research Group (Bloomfield), University College London; Royal Devon and Exeter NHS Foundation Trust, Exeter, U.K. (Broomby, Price); University College London Hospitals NHS Foundation Trust, London (Coathup, Gilhooly, Gordon-Williams, Brandner); South London and Maudsley NHS Foundation Trust, London (Hill, Harris); Faculty of Medicine, Department of Brain Sciences, Imperial College London (Lingford-Hughes).
Edward Palmer, M.D.
Psychopharmacology and Addiction Research Centre (Grabski, McAndrew, Marsh, Raymen, Stevens, Hardy, Maschauer, Palmer, Mollaahmetoglu, Morgan) and College of Medicine and Health (Warren), University of Exeter, Exeter, U.K.; Clinical Psychopharmacology Unit (Grabski, Lawn, Marsh, Bloomfield, Borissova, Curran) and Translational Psychiatry Research Group (Bloomfield), University College London; Royal Devon and Exeter NHS Foundation Trust, Exeter, U.K. (Broomby, Price); University College London Hospitals NHS Foundation Trust, London (Coathup, Gilhooly, Gordon-Williams, Brandner); South London and Maudsley NHS Foundation Trust, London (Hill, Harris); Faculty of Medicine, Department of Brain Sciences, Imperial College London (Lingford-Hughes).
Richard Gordon-Williams, M.D.
Psychopharmacology and Addiction Research Centre (Grabski, McAndrew, Marsh, Raymen, Stevens, Hardy, Maschauer, Palmer, Mollaahmetoglu, Morgan) and College of Medicine and Health (Warren), University of Exeter, Exeter, U.K.; Clinical Psychopharmacology Unit (Grabski, Lawn, Marsh, Bloomfield, Borissova, Curran) and Translational Psychiatry Research Group (Bloomfield), University College London; Royal Devon and Exeter NHS Foundation Trust, Exeter, U.K. (Broomby, Price); University College London Hospitals NHS Foundation Trust, London (Coathup, Gilhooly, Gordon-Williams, Brandner); South London and Maudsley NHS Foundation Trust, London (Hill, Harris); Faculty of Medicine, Department of Brain Sciences, Imperial College London (Lingford-Hughes).
Robert Hill, Ph.D.
Psychopharmacology and Addiction Research Centre (Grabski, McAndrew, Marsh, Raymen, Stevens, Hardy, Maschauer, Palmer, Mollaahmetoglu, Morgan) and College of Medicine and Health (Warren), University of Exeter, Exeter, U.K.; Clinical Psychopharmacology Unit (Grabski, Lawn, Marsh, Bloomfield, Borissova, Curran) and Translational Psychiatry Research Group (Bloomfield), University College London; Royal Devon and Exeter NHS Foundation Trust, Exeter, U.K. (Broomby, Price); University College London Hospitals NHS Foundation Trust, London (Coathup, Gilhooly, Gordon-Williams, Brandner); South London and Maudsley NHS Foundation Trust, London (Hill, Harris); Faculty of Medicine, Department of Brain Sciences, Imperial College London (Lingford-Hughes).
Jen Harris, D.Clin.Psych.
Psychopharmacology and Addiction Research Centre (Grabski, McAndrew, Marsh, Raymen, Stevens, Hardy, Maschauer, Palmer, Mollaahmetoglu, Morgan) and College of Medicine and Health (Warren), University of Exeter, Exeter, U.K.; Clinical Psychopharmacology Unit (Grabski, Lawn, Marsh, Bloomfield, Borissova, Curran) and Translational Psychiatry Research Group (Bloomfield), University College London; Royal Devon and Exeter NHS Foundation Trust, Exeter, U.K. (Broomby, Price); University College London Hospitals NHS Foundation Trust, London (Coathup, Gilhooly, Gordon-Williams, Brandner); South London and Maudsley NHS Foundation Trust, London (Hill, Harris); Faculty of Medicine, Department of Brain Sciences, Imperial College London (Lingford-Hughes).
O. Merve Mollaahmetoglu, M.Sc.
Psychopharmacology and Addiction Research Centre (Grabski, McAndrew, Marsh, Raymen, Stevens, Hardy, Maschauer, Palmer, Mollaahmetoglu, Morgan) and College of Medicine and Health (Warren), University of Exeter, Exeter, U.K.; Clinical Psychopharmacology Unit (Grabski, Lawn, Marsh, Bloomfield, Borissova, Curran) and Translational Psychiatry Research Group (Bloomfield), University College London; Royal Devon and Exeter NHS Foundation Trust, Exeter, U.K. (Broomby, Price); University College London Hospitals NHS Foundation Trust, London (Coathup, Gilhooly, Gordon-Williams, Brandner); South London and Maudsley NHS Foundation Trust, London (Hill, Harris); Faculty of Medicine, Department of Brain Sciences, Imperial College London (Lingford-Hughes).
H. Valerie Curran, D.Clin.Psych.
Psychopharmacology and Addiction Research Centre (Grabski, McAndrew, Marsh, Raymen, Stevens, Hardy, Maschauer, Palmer, Mollaahmetoglu, Morgan) and College of Medicine and Health (Warren), University of Exeter, Exeter, U.K.; Clinical Psychopharmacology Unit (Grabski, Lawn, Marsh, Bloomfield, Borissova, Curran) and Translational Psychiatry Research Group (Bloomfield), University College London; Royal Devon and Exeter NHS Foundation Trust, Exeter, U.K. (Broomby, Price); University College London Hospitals NHS Foundation Trust, London (Coathup, Gilhooly, Gordon-Williams, Brandner); South London and Maudsley NHS Foundation Trust, London (Hill, Harris); Faculty of Medicine, Department of Brain Sciences, Imperial College London (Lingford-Hughes).
Brigitta Brandner, M.D.
Psychopharmacology and Addiction Research Centre (Grabski, McAndrew, Marsh, Raymen, Stevens, Hardy, Maschauer, Palmer, Mollaahmetoglu, Morgan) and College of Medicine and Health (Warren), University of Exeter, Exeter, U.K.; Clinical Psychopharmacology Unit (Grabski, Lawn, Marsh, Bloomfield, Borissova, Curran) and Translational Psychiatry Research Group (Bloomfield), University College London; Royal Devon and Exeter NHS Foundation Trust, Exeter, U.K. (Broomby, Price); University College London Hospitals NHS Foundation Trust, London (Coathup, Gilhooly, Gordon-Williams, Brandner); South London and Maudsley NHS Foundation Trust, London (Hill, Harris); Faculty of Medicine, Department of Brain Sciences, Imperial College London (Lingford-Hughes).
Anne Lingford-Hughes, M.D., Ph.D.
Psychopharmacology and Addiction Research Centre (Grabski, McAndrew, Marsh, Raymen, Stevens, Hardy, Maschauer, Palmer, Mollaahmetoglu, Morgan) and College of Medicine and Health (Warren), University of Exeter, Exeter, U.K.; Clinical Psychopharmacology Unit (Grabski, Lawn, Marsh, Bloomfield, Borissova, Curran) and Translational Psychiatry Research Group (Bloomfield), University College London; Royal Devon and Exeter NHS Foundation Trust, Exeter, U.K. (Broomby, Price); University College London Hospitals NHS Foundation Trust, London (Coathup, Gilhooly, Gordon-Williams, Brandner); South London and Maudsley NHS Foundation Trust, London (Hill, Harris); Faculty of Medicine, Department of Brain Sciences, Imperial College London (Lingford-Hughes).
Psychopharmacology and Addiction Research Centre (Grabski, McAndrew, Marsh, Raymen, Stevens, Hardy, Maschauer, Palmer, Mollaahmetoglu, Morgan) and College of Medicine and Health (Warren), University of Exeter, Exeter, U.K.; Clinical Psychopharmacology Unit (Grabski, Lawn, Marsh, Bloomfield, Borissova, Curran) and Translational Psychiatry Research Group (Bloomfield), University College London; Royal Devon and Exeter NHS Foundation Trust, Exeter, U.K. (Broomby, Price); University College London Hospitals NHS Foundation Trust, London (Coathup, Gilhooly, Gordon-Williams, Brandner); South London and Maudsley NHS Foundation Trust, London (Hill, Harris); Faculty of Medicine, Department of Brain Sciences, Imperial College London (Lingford-Hughes).

Notes

Send correspondence to Prof. Morgan ([email protected]).

Author Contributions

Drs. Grabski and McAndrew are co-first authors.

Competing Interests

Drs. Grabski, McAndrew, Lawn, Marsh, Hill, Harris, and Morgan have received royalties for KARE therapy license distribution; KARE therapy is licensed from University of Exeter to Awakn Life Sciences. Ms. Mollaahmetoglu has conducted research work funded by Awakn Life Sciences. Dr. Bloomfield owns shares in Bloomfield Health Holdings Limited. Prof. Curran has served as a consultant for Janssen Research and Development. Prof. Lingford-Hughes has received Ph.D. funding from Alcarelle and an honorarium from Lundbeck for an educational talk and has served as a consultant for Silence Therapeutics. Prof. Morgan has received research funding from Awakn Life Sciences and has served as a consultant for Janssen Pharmaceuticals. The other authors report no financial relationships with commercial interests.

Funding Information

Supported by Medical Research Council grant L-023032 to Dr. Morgan, Dr. Lingford-Hughes, and Dr. Curran.

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