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
Protocol serial number	PCC16 T84 8846
Sponsor	NHS R&D Regional Programme Register - Department of Health (UK)
Funder	NHS Executive Northern and Yorkshire (UK)

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

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant 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
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Benzodiazepine
Primary outcome measure(s)	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).
Key secondary outcome measure(s)	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.
Completion date	23/03/1999

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	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

United Kingdom
England

Study participating centre

Centre for Alcohol and Drug Studies

Newcastle upon Tyne
NE1 6UR
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes