A pilot randomised trial to compare a new alcohol detoxification technique with current practice
| ISRCTN | ISRCTN75811340 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN75811340 |
| Secondary identifying numbers | N0222126418 |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 19/02/2020
- 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
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Ed Day
Scientific
Scientific
ABC
120 Corporation Street
Birmingham
B4 6SX
United Kingdom
| Phone | +44 (0)121 685 6180 |
|---|---|
| ejday@blueyonder.co.uk |
Study information
| Study design | Non blind randomised controlled pilot study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | A pilot randomised trial to compare a new alcohol detoxification technique with current practice |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/01/2003 |
| Completion date | 30/05/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 40 |
| Total final enrolment | 23 |
| Key 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. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/2003 |
| Date of final enrolment | 30/05/2003 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
ABC
Birmingham
B4 6SX
United Kingdom
B4 6SX
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
Government
Birmingham and Solihull Mental Health NHS Trust (UK)
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 02/01/2018 | 19/02/2020 | Yes | No |
Editorial Notes
19/02/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
