Randomised controlled trial of carbamazepine assisted detoxification in patients with benzodiazepine dependence

ISRCTN	ISRCTN44535130
DOI	https://doi.org/10.1186/ISRCTN44535130
Secondary identifying numbers	N0133160479

Submission date: 30/09/2005
Registration date: 30/09/2005
Last edited: 27/10/2015

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 Chris Daly
Scientific

Wentworth House
Mental Health Services of Salford
8 Westminster Road
Eccles
Salford
M30 9HF
United Kingdom

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Randomised controlled trial of carbamazepine assisted detoxification in patients with benzodiazepine dependence
Study objectives	1. Carbamazepine minimizes severity and incidence of benzodiazepine withdrawal symptoms. 2. Carbamazepine assisted detoxification increases the abstinence rates of benzodiazopines in short term.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Mental and Behavioural Disorders: Addiction
Intervention	1. Carbamazepine assisted benzodiazepine detox for 2 weeks 2. Traditional gradual withdrawal of diazepam Observers will be blinded from allocation of groups. Analysis of Variance (ANOVA) will be used to compare 2 groups.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Carbamazepine
Primary outcome measure	1. Benzodiazepine withdrawal symptom questionnaire (30 items) 2. Hamilton Depression Rating Scale (17 items) HAM-D) 3. Hamilton Anxiety Rating Scale (HAM-A) 4. Abstinence rates from benzodiazepines Patients will be assessed at 3 points: 1. Baseline 2. 1 week after starting the detoxification 3. 2 weeks (end of detoxification) Follow-up interview or phone call will be made 4 weeks after discharge asking if patient are abstinent from benzodiazepines.
Secondary outcome measures	Not provided at time of registration
Overall study start date	21/09/2004
Completion date	30/05/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	65 Years
Sex	Both
Target number of participants	Target total for recruitment: 50
Key inclusion criteria	Patients (18-65 years) who are admitted to Wentworth House or Kenyon House in-patient units, and are using daily doses of benzodiazepine for at least 3 months.
Key exclusion criteria	1. Significant psychiatric disorders (by ICD 10) 2. History of or current liver failure 3. Current Alanine Transaminase ( ALT) > or equal 150 IU/l in serum LFT 4. Current suicidal ideation 5. Patients who are already on Carbamazepine before referral for In Patient treatment.
Date of first enrolment	21/09/2004
Date of final enrolment	30/05/2006

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Wentworth House

Salford
M30 9HF
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone	+44 (0)20 7307 2622
Email	dhmail@doh.gsi.org.uk
Website	http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Bolton, Salford and Trafford Mental Health NHS Trust (UK), NHS R&D Support Funding

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan