A proof-of-concept investigation into ketamine as a pharmacological treatment for alcohol dependence: study protocol for a randomised controlled trial
Amy Mcandrew, Will Lawn, Tobias Stevens, Lilla Alexandra Porffy, Brigitta Brandner, Celia J. A. Morgan
Trials April 4, 2017 DOI: 10.1186/s13063-017-1895-6 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Randomized controlled trial Placebo-controlled Double-blind Peer reviewed |
|---|---|
| Sample size | 96 |
| Population | Recently detoxified adults with alcohol dependence and comorbid depressive symptoms |
| Interventions | Ketamine psychological therapy alcohol education control |
| Dose | 0.8 mg/kg administered intravenously over 40 minutes; placebo 50 ml saline 0.9% IV over 40 minutes |
| Duration | Three treatment sessions; assessments at 3 and 6 months |
| Topics | Addiction Esketamine Ketamine |
| Citations | 20 |
| Registration | NCT02649231 |
| Key findings | The protocol proposes that combining repeated ketamine infusions with manualised psychological therapy may reduce relapse in severe alcohol use disorder, and describes a four-arm randomized trial designed to test this against placebo and an alcohol education control. No outcome data are reported; the authors state the trial will assess relapse rates and percentage days abstinent at six months. |
Abstract
Background: Worldwide, alcohol abuse is a burgeoning problem. Abstinence is key to allow recovery of physical and mental health as well as quality of life, but treatment for alcohol dependence is associated with high relapse rates. Preliminary data have suggested that a combined repeated ketamine and psychological therapy programme may be effective in reducing relapse in severe alcohol use disorder. This non-commercial proof-of-concept trial is aimed at making a preliminary assessment of the effectiveness of this combined treatment in this patient group. METHODS/DESIGN: This is a phase II, randomised, double-blind, placebo-controlled, parallel-group clinical trial taking place in two sites in the UK: the South West of England and London. Ninety-six recently detoxified alcoholics, with comorbid depressive symptoms, will be randomised to one of four treatment arms. Patients will receive either three sessions of ketamine (0.8 mg/kg administered intravenously (IV) over 40 minutes) or placebo (50 ml saline 0.9% IV over 40 minutes) plus either seven sessions of manualised psychological therapy or an alcohol education control. Patients will be assessed at 3 and 6 months on a range of psychological and biological variables. The primary endpoints are (1) relapse rates at 6 months and (2) percentage days abstinent at 6 months. Secondary endpoints include 3 and 6 month percentage days abstinence, tolerability (indicated by dropout), adverse events, depressive symptoms, craving and quality of life.
Discussion: This study will provide important information on a new combined psychological and pharmacological intervention aimed at reducing relapse rates in alcoholics. The findings would have broad application given the worldwide prevalence of alcoholism and its associated medical, psychological and social problems.
Trial Registration: ClinicalTrials.gov, NCT02649231 . Registered on 5 January 2016.
Comparable studies
Other randomized controlled trials on ketamine for addiction, most cited first.
Citations in the library
Cited by 12
- Adjunctive Ketamine With Relapse Prevention–Based Psychological Therapy in the Treatment of Alcohol Use Disorder American Journal of Psychiatry January 11, 2022
- Therapeutic Potentials of Ketamine and Esketamine in Obsessive–Compulsive Disorder (OCD), Substance Use Disorders (SUD) and Eating Disorders (ED): A Review of the Current Literature Brain Sciences June 27, 2021
- Integrating psychotherapy and psychopharmacology: psychedelic-assisted psychotherapy and other combined treatments Expert Review of Clinical Pharmacology June 1, 2020
- "This Is Something That Changed My Life": A Qualitative Study of Patients' Experiences in a Clinical Trial of Ketamine Treatment for Alcohol Use Disorders. Frontiers in Psychiatry 2021
- Classic and non‐classic psychedelics for substance use disorder: A review of their historic, past and current research Addiction Neuroscience June 22, 2022
and 7 more in the library
Cites 6
- A Randomized Trial of an N-methyl-D-aspartate Antagonist in Treatment-Resistant Major Depression Archives of General Psychiatry August 1, 2006
- mTOR-Dependent Synapse Formation Underlies the Rapid Antidepressant Effects of NMDA Antagonists Science August 19, 2010
- Ketamine Psychedelic Therapy (KPT): A Review of the Results of Ten Years of Research Journal of Psychoactive Drugs June 1, 1997
- Ketamine-Enhanced Psychotherapy: Preliminary Clinical Observations on its Effects in Treating Death Anxiety International Journal of Transpersonal Studies 2007
- Neurotoxicity and persistent cognitive deficits induced by combined MDMA and alcohol exposure in adolescent rats Addiction Biology October 1, 2010
and 1 more in the library