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ISRCTN
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ISRCTN33971222
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ClinicalTrials.gov identifier
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Public title
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A double-blind randomised placebo controlled trial of symptom-triggered alcohol detoxification on a general psychiatric ward.
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0151123769
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Study hypothesis
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To test the null hypothesis that there is no significant difference in length of hospital stay between subjects administered symptom-triggered alcohol detoxification and those receiving a detoxification according to usual clinical practice.
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Lay summary
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Not provided at time of registration
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Mental and Behavioural Disorders: Alcohol dependence
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Participants - inclusion criteria
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70 patients admitted to one ward and who are identified by staff as requiring alcohol detoxification at the point of admission, and who meet International Statistical Classification of Diseases and Related Health Problems - tenth revision (ICD10) criteria for alcohol dependency.
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Participants - exclusion criteria
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Does not meet inclusion criteria
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Anticipated start date
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01/04/2003
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Anticipated end date
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30/03/2004
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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70
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Interventions
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Double blind randomised control trial of two methods of alcohol detoxification. Randomised to 'symptom-triggered alcohol detoxification' or detoxification according to 'usual clinical practice'.
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Primary outcome measure(s)
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1. Description of demographics: means, confidence intervals, medians, ranges.
2. Duration of detoxification: means, confidence intervals, t-tests.
3. Rates of completion of detoxification: percentages, chi-square.
4. Intensity of withdrawal symptoms: repeated measures analysis of variance (ANOVA).
5. Overall patient satisfaction: means, t-test.
6. Occurrence of complications of withdrawal: qualitative analysis for physical complications; repeated measures ANOVA for psychiatric symptoms.
7. Total medication used: means, t-tests.
8. Prognostic indicators for various outcomes: ANOVA, analysis of covariance (ANCOVA), linear and logistic regressions.
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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North Essex Mental Health Partnership NHS Trust (UK)
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Trial website
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Publications
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Contact name
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Dr
Bruce
Trathen
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Address
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CDAT
Aylmer House
Kitson Way
The High
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City/town
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Harlow
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Zip/Postcode
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CM20 1DL
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Country
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United Kingdom
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Sponsor
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Record Provided by the NHSTCT Register - 2004 Update - Department of Health (UK)
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Address
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The Department of Health,
Richmond House,
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.dh.gov.uk/Home/fs/en
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Date applied
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30/09/2004
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Last edited
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16/05/2012
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Date ISRCTN assigned
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30/09/2004
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