Evidence map›Paper›PMID 27677382›Full record

ArticleTrials2016

Improving GHB withdrawal with baclofen: study protocol for a feasibility study for a randomised controlled trial.

Anne Lingford-Hughes, Yash Patel, Owen Bowden-Jones, Mike J Crawford, Paul I Dargan, Fabiana Gordon, Steve Parrott, Tim Weaver, David M Wood

Open access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
2.4field-weighted citation impact, top 14% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 49 citations in OpenAlex.

  1. Review
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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

9 authors at 5 institutions in 1 country.

Anne Lingford-HughesCentral North West London NHS Foundation Trust's Club Drug Clinic, 69 Warwick Rd, London, SW5 9HB, UK. anne.lingford-hughes@imperial.ac.uk.ORCID http://orcid.org/0000-0003-4512-3453
Yash PatelCentral North West London NHS Foundation Trust's Club Drug Clinic, 69 Warwick Rd, London, SW5 9HB, UK.
Owen Bowden-JonesCentral North West London NHS Foundation Trust's Club Drug Clinic, 69 Warwick Rd, London, SW5 9HB, UK.
Mike J CrawfordCentral North West London NHS Foundation Trust's Club Drug Clinic, 69 Warwick Rd, London, SW5 9HB, UK.
Paul I DarganGuy's and St. Thomas NHS Foundation Trust, London, UK.
Fabiana GordonStatistical Advisory Service, School Of Public Health, Imperial College London, London, UK.
Steve ParrottDepartment of Health Sciences, The University of York, York, UK.
Tim WeaverDepartment of Mental Health, Social Work and Integrative Medicine, Middlesex University, London, UK.
David M WoodGuy's and St. Thomas NHS Foundation Trust, London, UK.
Central and North West London NHS Foundation Trust · GBKing's College London · GBMiddlesex University · GBRoyal Statistical Society · GBUniversity of York · GB

Funding

Department of Health PB-PG-0212-27068
6 · The paper itself

Abstract

backgroundGHB (gamma-hydroxybutyrate) and its pro-drugs GBL (gamma-butyrolactone) and 1,4-butanediol (1,4-BD) are central nervous system depressants whose street names include 'G' and 'liquid ecstasy'. They are used recreationally predominately for their stimulant and pro-sexual effects or for sedation to help with sleep and/or to 'come down' after using stimulant recreational drugs. Although overall population prevalence is low (0.1 %), in some groups such as men who have sex with men, GHB/GBL use may reach 20 %. GHB/GBL dependence may be associated with severe withdrawal with individuals presenting either acutely to emergency departments or to addiction services for support. Benzodiazepines are currently prescribed for GHB/GBL detoxification but do not prevent all complications, such as behavioural disinhibition, that may require hospitalisation or admission to a high dependency/intensive care unit. The GABA METHODS/

designThis is a prospective, randomised, double-blind, placebo-controlled feasibility study that will recruit participants (aged over 18 years) who are GHB/GBL-dependent and wish to undergo planned GHB/GBL detoxification or are at risk of acute withdrawal and are inpatients requiring unplanned withdrawal. We aim to recruit 88 participants: 28 unplanned inpatients and 60 planned outpatients. During detoxification we will compare baclofen 10 mg three times a day with placebo as an adjunct to the usual benzodiazepine regimen. In the planned outpatient arm, we will also compare a 2-day preload of baclofen 10 mg three times a day with placebo. Ratings of GHB/GBL withdrawal, sleep, depression, anxiety as well as GHB/GBL use will be collected. The main data analyses will be descriptive about recruitment and characterising the impact of adding baclofen to the usual benzodiazepine regimen on measures and outcomes of GHB/GBL withdrawal to provide estimates of variability and effect size. A qualitative approach will evaluate research participant and clinician acceptability and data collected to inform cost-effectiveness. DISCUSSION: This feasibility study will inform a randomised controlled trial to establish whether adding baclofen to a benzodiazepine regimen reduces the severity and complications of GHB/GBL withdrawal.

trial registrationISRCTN59911189 . Registered 14 October 2015. PROTOCOL: v3.1, 1 February 2016.

Indexed as

BaclofenBenzodiazepineGABABGamma-butyrolactoneGamma-hydroxybutyrateGBLGHBGHB/GBL dependenceGHB/GBL withdrawal

Identifiers

PMID27677382
PMCPMC5039898
OpenAlexW2523965896

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.