Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
PCC16 T84 8846
Study information
Scientific title
Not provided at time of registration
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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 names
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 trial start date
24/03/1997
Overall trial end date
23/03/1999
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients on benzodiazepines.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
284
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
24/03/1997
Recruitment end date
23/03/1999
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Centre for Alcohol and Drug Studies
Newcastle upon Tyne
NE1 6UR
United Kingdom
Sponsor information
Organisation
NHS R&D Regional Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Executive Northern and Yorkshire (UK)
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
Basic results (scientific)
Publication list
1. 2001 results in http://www.ncbi.nlm.nih.gov/pubmed/11599510
Publication citations
-
Results
Heather N, Brief interventions for substance use disorders other than alcohol., Addiction, 2001, 96, 10, 1511-1512.