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

ISRCTN	ISRCTN33971222
DOI	https://doi.org/10.1186/ISRCTN33971222
Protocol serial number	N0151123769
Sponsor	Department of Health
Funder	North Essex Mental Health Partnership NHS Trust (UK)

Submission date: 30/09/2004
Registration date: 30/09/2004
Last edited: 03/11/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Bruce Trathen
Scientific

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

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A double-blind randomised placebo-controlled trial of symptom-triggered alcohol detoxification on a general psychiatric ward
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	30/03/2004

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	70
Key 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.
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	01/04/2003
Date of final enrolment	30/03/2004

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

CDAT

Harlow
CM20 1DL
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

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