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
A pilot randomised trial to compare a new alcohol detoxification technique with current practice
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 measure
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 (if study stopped)
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
Total final enrolment
23
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
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
Basic results (scientific)
Publication list
2004 results in https://www.cambridge.org/core/services/aop-cambridge-core/content/view/4119DCCF9B6A11D55530F4911968F526/S0955603600006784a.pdf/div-class-title-evaluation-of-a-symptom-triggered-front-loading-detoxification-technique-for-alcohol-dependence-a-pilot-study-div.pdf (added 19/02/2020)