Condition category
Mental and Behavioural Disorders
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
03/11/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Bruce Trathen

ORCID ID

Contact details

CDAT
Aylmer House
Kitson Way
The High
Harlow
CM20 1DL
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0151123769

Study information

Scientific title

A double-blind randomised placebo-controlled trial of symptom-triggered alcohol detoxification on a general psychiatric ward

Acronym

Study hypothesis

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.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Mental and Behavioural Disorders: Alcohol dependence

Intervention

Double blind randomised control trial of two methods of alcohol detoxification. Randomised to 'symptom-triggered alcohol detoxification' or detoxification according to 'usual clinical practice'.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

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.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/04/2003

Overall trial end date

30/03/2004

Reason abandoned

Eligibility

Participant inclusion criteria

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.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

70

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/04/2003

Recruitment end date

30/03/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

CDAT
Harlow
CM20 1DL
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Hospital/treatment centre

Funder name

North Essex Mental Health Partnership NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

03/11/2015: no publications found on PubMed.