Condition category
Mental and Behavioural Disorders
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
12/04/2012
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 Nick Heather

ORCID ID

Contact details

Centre for Alcohol and Drug Studies
Northern Regional Alcohol & Drug Service
Plumer Court
Carliol Square
Newcastle upon Tyne
NE1 6UR
United Kingdom
+44 (0)191 219 5648

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 measures

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

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

http://www.doh.gov.uk

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

Results - basic reporting

Publication summary

1. 2001 results in http://www.ncbi.nlm.nih.gov/pubmed/11599510

Publication citations

  1. Results

    Heather N, Brief interventions for substance use disorders other than alcohol., Addiction, 2001, 96, 10, 1511-1512.

Additional files

Editorial Notes