Evidence map›Paper›PMID 28372596›Full record

Trial reportTrials2017

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 Porffy, Brigitta Brandner, Celia J A Morgan

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02649231 (A Phase II, Randomised, Double-blind, Placebo- Controlled, Multi-site, Parallel Group Clinical Trial to Examine Ketamine as a Pharmacological Treatment for Alcohol Dependence in an Alcohol Dependent Population), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.5field-weighted citation impact, top 19% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02649231 phase2completednot on this map

A Phase II, Randomised, Double-blind, Placebo- Controlled, Multi-site, Parallel Group Clinical Trial to Examine Ketamine as a Pharmacological Treatment for Alcohol Dependence in an Alcohol Dependent Population

TypeinterventionalSponsorUniversity College, LondonRan2016 to 2020Enrolled96ConditionsPrimary Alcohol Use DisorderArmsKetamine, Placebo, Psychological Therapy, Alcohol Education
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 19 citations in OpenAlex.

  1. Review
  2. Article
  3. Article
  4. Neuroimmune signaling in alcohol use disorder.Pharmacology, biochemistry, and behavior · 2019
    Review
  5. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 3 institutions in 2 countries.

Amy McAndrewPsychopharmacology and Addiction Research Centre (PARC), College of Life and Environmental Science, University of Exeter, Washington Singer Building, Perry Road, Exeter, EX4 4QG, UK. a.mcandrew@exeter.ac.uk.ORCID 0000-0001-8021-3257
Will LawnClinical Psychopharmacology Unit, University College London, 1-19 Torrington Place, London, WC1E 7HB, UK.
Tobias StevensPsychopharmacology and Addiction Research Centre (PARC), College of Life and Environmental Science, University of Exeter, Washington Singer Building, Perry Road, Exeter, EX4 4QG, UK.
Lilla PorffyClinical Psychopharmacology Unit, University College London, 1-19 Torrington Place, London, WC1E 7HB, UK.
Brigitta BrandnerAnaesthetics Department, Podium 3, maple Link corridor, Unviersity College Hospital, 235 Euston Road, London, NW1 2BU, UK.
Celia J A MorganPsychopharmacology and Addiction Research Centre (PARC), College of Life and Environmental Science, University of Exeter, Washington Singer Building, Perry Road, Exeter, EX4 4QG, UK.
University of Exeter · GBUniversity College London · GBUniversity College Hospital · GB

Funding

Medical Research Council MR/L023032/1
6 · The paper itself

Abstract

backgroundWorldwide, 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/

designThis 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 registrationClinicalTrials.gov, NCT02649231 . Registered on 5 January 2016.

Indexed as

AdolescentAdultAlcohol AbstinenceAlcohol DrinkingAlcoholismCombined Modality TherapyDouble-Blind MethodDrug Administration ScheduleEnglandFemaleHumansInfusions, IntravenousKetamineMaleMiddle AgedPatient Education as TopicKetamineAlcoholismDepressionKetamineRelapse

Identifiers

PMID28372596
PMCPMC5379743
OpenAlexW2604340903

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.