Condition category
Mental and Behavioural Disorders
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
27/10/2015
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 Chris Daly

ORCID ID

Contact details

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

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 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes