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dc.contributor.authorMcAndrew, A
dc.contributor.authorLawn, W
dc.contributor.authorStevens, T
dc.contributor.authorPorffy, L
dc.contributor.authorBrandner, B
dc.contributor.authorMorgan, CJA
dc.date.accessioned2017-06-20T12:39:04Z
dc.date.issued2017-04-04
dc.description.abstractBACKGROUND: 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.en_GB
dc.description.sponsorshipThis study is funded by a grant awarded to CM by the Medical Research Council (MR/L023032/1).en_GB
dc.identifier.citationVol. 18, pp. 159 -en_GB
dc.identifier.doi10.1186/s13063-017-1895-6
dc.identifier.other10.1186/s13063-017-1895-6
dc.identifier.urihttp://hdl.handle.net/10871/28108
dc.language.isoenen_GB
dc.publisherBioMed Centralen_GB
dc.relation.urlhttps://www.ncbi.nlm.nih.gov/pubmed/28372596en_GB
dc.rights© The Author(s). 2017 This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.en_GB
dc.subjectAlcoholismen_GB
dc.subjectDepressionen_GB
dc.subjectKetamineen_GB
dc.subjectRelapseen_GB
dc.titleA proof-of-concept investigation into ketamine as a pharmacological treatment for alcohol dependence: study protocol for a randomised controlled trial.en_GB
dc.typeArticleen_GB
dc.date.available2017-06-20T12:39:04Z
exeter.place-of-publicationEnglanden_GB
dc.descriptionPublished onlineen_GB
dc.descriptionJournal Articleen_GB
dc.descriptionThis is the final version of the article. Available from BioMed Central via the DOI in this record.en_GB
dc.identifier.eissn1745-6215
dc.identifier.journalTrialsen_GB


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