Condition category
Mental and Behavioural Disorders
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
12/01/2010
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 Ed Day

ORCID ID

Contact details

ABC
120 Corporation Street
Birmingham
B4 6SX
United Kingdom
+44 (0)121 685 6180
ejday@blueyonder.co.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0222126418

Study information

Scientific title

Acronym

Study hypothesis

How does the front-loading technique using diazepam compare to standard detoxification treatment for alcohol withdrawal in terms of:
1. Number of completed detoxifications
2. Average daily withdrawal severity score
3. Amount of medication used
4. Duration of detoxification
5. Patient satisfaction

Ethics approval

Not provided at time of registration

Study design

Non blind randomised controlled pilot study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Mental and Behavioural Disorders: Alcohol dependence

Intervention

A non blind randomised controlled trial comparing diazepam front loading treatment with a standard 10 day chlordiazepoxide regime.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Number of completed detoxification programmes
2. Average daily withdrawal severity as measured by the Clinical Institute Withdrawal Assessment for Alcohol, Revised (CIWA-Ar) score
3. Amount of medication used
4. Duration of detoxification
5. Patient satisfaction

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/2003

Overall trial end date

30/05/2003

Reason abandoned

Eligibility

Participant inclusion criteria

All patients will have a semi-structured alcohol history taken on admission (approx 30/40)

Each patient consenting to participate in the study will be randomly allocated to either the treatment group or the control group.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

40

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/01/2003

Recruitment end date

30/05/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

ABC
Birmingham
B4 6SX
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

Government

Funder name

Birmingham and Solihull Mental Health 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

Day E, Patel J & Georgiou G. A pilot study to evaluate a symptom-triggered front-loading detoxification technique for alcohol dependence Psychiatric Bulletin, (2004)28(11):407-410
http://pb.rcpsych.org/cgi/content/abstract/28/11/407

Publication citations

Additional files

Editorial Notes