Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0133160479
Study information
Scientific title
Randomised controlled trial of carbamazepine assisted detoxification in patients with benzodiazepine dependence
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
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: 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
Phase
Not Applicable
Drug names
Carbamazepine
Primary outcome measures
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 trial start date
21/09/2004
Overall trial end date
30/05/2006
Reason abandoned
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Target total for recruitment: 50
Participant 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.
Recruitment start date
21/09/2004
Recruitment end date
30/05/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Wentworth House
Salford
M30 9HF
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Bolton, Salford and Trafford Mental Health NHS Trust (UK), NHS R&D Support Funding
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