Condition category
Mental and Behavioural Disorders
Date applied
30/07/2008
Date assigned
21/08/2008
Last edited
24/11/2008
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 Gabriel Rubio

ORCID ID

Contact details

Hospital Universitario 12 de Octubre
Department of Psychiatry
Avda Cordoba s/n
Madrid
28047
Spain
+34 63 920 1870
garuva@inicia.es

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

binger01

Study information

Scientific title

Efficacy of brief interventions (BI) for binge drinkers

Acronym

BINGER

Study hypothesis

To test the effect of brief interventions (BI) in a sample consisting exclusively of binge drinkers.

Please note that, as of 24/11/2008, the following amemndments were made to this trial record due to errors in inforamtion provided at time of registration:

1. Start and end dates were amended from 01/11/2008 and 01/11/2008 to 01/03/2003 and 01/03/2006, respectively
2. The target number of recruitment was changed from 2,433 to 752. The former is the number of participants who screened positive (i.e. binge drinking pattern and Alcohol Use Disorders Identification Test [AUDIT] score 15 or lower), whereas the latter is the number of participants who were randomised to the trial arms

Ethics approval

Ethics Committee of the University Hospital "12 de Octubre" (Hospital Universitario 12 de Octubre). Date of approval: 23/04/2008 (ref: 2008-45-2)

Study design

Multi-centre, randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details provided in the Interventions field to request a patient information sheet

Condition

High-risk alcohol drinkers

Intervention

This is a randomised controlled trial with a 12-month follow-up period conducted by 74 physicians in 20 primary care centres in Spain.

The brief intervention by the physician consisted of 2 short counselling sessions 4 weeks apart. Each 10 to 15-minute face-to-face counselling session was offered within the context of routine patient care by a physician using a scripted workbook. The intervention workbook included a review of alcohol-related health effects, a pie chart displaying the frequency of different types of at-risk drinkers, a list of methods for cutting down drinking, a treatment contract, and cognitive behavioural exercises.

Subjects assigned to the control group received a booklet on general health issues and were followed up at 6 and 12 months. They were instructed to address any health concerns in their usual manner.

Please use the following contact details to request a patient information sheet:
Hospital Universitario 12 de Octubre
Department of Psychiatry
Avda Cordoba s/n
Madrid, 28047
Spain
Tel: +34 91 390 8022

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Change in alcohol use: number of binge episodes (>5 drinks for men and >4 drinks for women on a single occasion) in the previous month and the percentage of bingers, assessed at baseline, 6 and 12 months.

Secondary outcome measures

Changes in weekly alcohol consumption and rates of excessive drinking in the previous 7 days (more than 18 drinks per week for men and more than 13 drinks per week for women), assessed at baseline, 6 and 12 months.

Overall trial start date

01/03/2003

Overall trial end date

01/03/2006

Reason abandoned

Eligibility

Participant inclusion criteria

All adults patients aged 18 to 65 years of age will be asked to undergo alcohol use disorders screening (Alcohol Use Disorders Identification Test [AUDIT]) (Rubio et al., 1998) by their primary care physicians (PCPh). All patients who screen positive will be contacted and invited to participate in a face-to-face interview to determine their eligibility for the trial. Patients will be eligible for the randomised trial if they report a pattern of binge drinking and score 15 or lower on the AUDIT (scores above 15 were referred to the Drug Abuse Programme for Treatment). Patients eligible for the study will be binge drinkers, defined as men who had drunk 5 or more standard drinks per occasion (12.8 g of alcohol per drink) on 1 or more occasions in the previous month. Women will be included in the study sample if they had drunk 4 or more standard drinks per occasion on 1 or more occasions in the previous month.

Rubio, G., Bermejo, J., Caballero, C., Santo-Domingo, J. Validación del test de identificación de trastornos por uso de alcohol (AUDIT) en atención primaria (Spanish validation of the Alcohol Use Disorders Identification Test [AUDIT] in primary care). Rev Clin Esp 1998; 198: 11-14.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

752

Participant exclusion criteria

1. Pregnant women
2. Plan to move out of the area within the year
3. Do not have a telephone
4. Those who are already participating in an alcohol intervention programme
5. Those who have an Axis I psychiatric disorder (American Psychiatric Association [APA] 2000) other than substance abuse that, in the judgment of the PCPh, prevents them from participating
6. Unable to complete the informed consent

Recruitment start date

01/03/2003

Recruitment end date

01/03/2006

Locations

Countries of recruitment

Spain

Trial participating centre

Hospital Universitario 12 de Octubre
Madrid
28047
Spain

Sponsor information

Organisation

Brain and Mind Foundation (Fundacion Cerebro y Mente) (Spain)

Sponsor details

General Oraa 67
Madrid
28041
Spain

Sponsor type

Research organisation

Website

http://www.cermente.com/en

Funders

Funder type

Research organisation

Funder name

Brain and Mind Foundation (Fundacion Cerebro y Mente) (Spain)

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

Publication citations

Additional files

Editorial Notes