Reducing long-term benzodiazepine use: effectiveness and cost-effectiveness of two minimal interventions and development of guidelines for case management
| ISRCTN | ISRCTN69763877 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN69763877 |
| Secondary identifying numbers | PCC16 T84 8846 |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 12/04/2012
- 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 Nick Heather
Scientific
Scientific
Centre for Alcohol and Drug Studies
Northern Regional Alcohol & Drug Service
Plumer Court
Carliol Square
Newcastle upon Tyne
NE1 6UR
United Kingdom
| Phone | +44 (0)191 219 5648 |
|---|
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Not provided at time of registration |
| Study objectives | Recent studies have shown that two inexpensive interventions (a brief GP consultation and a letter from the patients GP) can be effective in leading to reduced benzodiazepine (BZD) intake in long-term users. In a randomised controlled trial, we will directly compare the effectiveness and cost-effectiveness of these two interventions and search for patient and other variables predictive of successful and unsuccessful response to intervention. We will then use the results to develop a set of guidelines for rational deployment of three levels of intervention against long-term BZD use: 1. A GP letter advising gradual reduction 2. A short GP consultation plus self-help booklet 3. Specialised intervention at a benzodiazepine withdrawal clinic |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Depression, anxiety, neuroses |
| Intervention | 1. A brief GP consultation 2. A letter from the GP advising gradual reduction |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Benzodiazepine |
| Primary outcome measure | Effectiveness in curtailing long term use of benzodiazepines and cost-effectiveness of the two interventions. The main outcome measure was change in BZD intake between the six-month periods before and after the intervention. This was taken from practice prescription records and was available for all 273 patients entering the analysis. BZD intake for each patient was converted to a standard measure of 10 mg diazepam equivalents (Ashton, 1994). |
| Secondary outcome measures | A subsidiary outcome measure was whether or not the patient was a "true reducer", defined as having reduced BZD intake by a quarter or more, including those who had stopped intake completely. |
| Overall study start date | 24/03/1997 |
| Completion date | 23/03/1999 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 284 |
| Key inclusion criteria | Patients on benzodiazepines. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 24/03/1997 |
| Date of final enrolment | 23/03/1999 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Centre for Alcohol and Drug Studies
Newcastle upon Tyne
NE1 6UR
United Kingdom
NE1 6UR
United Kingdom
Sponsor information
NHS R&D Regional Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.doh.gov.uk |
Funders
Funder type
Government
NHS Executive Northern and Yorkshire (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 | 01/10/2001 | Yes | No |
