NCT01348113

Brief Summary

Excessive alcohol consumption is a worldwide major public health problem. Brief interventions have shown to be an efficient treatment modality for problem drinkers, but have never been tested in scheduled surgery. Patients will be recruited in various surgery units in 7 hospital in France. All patients attending a scheduled surgery will be screened during the visit with the anaesthesist by the Alcohol Use Disorders Identification Test (AUDIT). Patients aged 30-75 with an AUDIT between 7 and 12, corresponding to at risk or harmful use, will be proposed to enter a control study and randomized between a brief intervention by a trained nurse during the post-surgery hospitalisation and no intervention. Twelve months after the surgery, a research technician will interview by telephone patients and evaluate AUDIT and alcohol consumption of the last month.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jul 2010

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

July 2, 2010

Completed
10 months until next milestone

First Posted

Study publicly available on registry

May 5, 2011

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

May 1, 2014

Status Verified

April 1, 2014

Enrollment Period

1.8 years

First QC Date

July 2, 2010

Last Update Submit

April 30, 2014

Conditions

Alcohol AbuseAlcohol ProblemAOD Misuse

Keywords

Alcohol Use Disorders Identification Testalcohol dependenceAlcohol problem

Outcome Measures

Primary Outcomes (1)

  • Rate of patients getting back to an Alcohol Use Disorders Identification Test score <7

    1 year

Secondary Outcomes (8)

  • Evolution of the Alcohol Use Disorders Identification Test score

    1 year

  • Alcohol consumption in the month preceding the final evaluation at 1 year

    1 year

  • Gamma-GT and CDT evolution

    1 year

  • Frequency of normalization of gamma-GT and CDT measures

    1 year

  • Rate of patients in the Brief Alcohol Intervention group getting back to an Alcohol Use Disorders Identification Test score <7, with stratification on the Prochaska score

    1 year

  • +3 more secondary outcomes

Study Arms (2)

Brief Alcohol Intervention

EXPERIMENTAL
Other: Brief Alcohol intervention

No intervention

NO INTERVENTION

Interventions

Brief Alcohol interventionOTHER

Brief intervention consists typically in a brief assessment, giving patients personal feedback, dealing with resistance and ambivalence, establishing a goal of reduced alcohol use, and giving a workbook; reinforcement visits or calls are included.

Also known as: BAI
Brief Alcohol Intervention

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Man or woman
  • Aged 30 to 75 years old
  • With a scheduled surgery
  • Presenting an Alcohol Use Disorders Identification Test score between 7 and 12 (included) during the routine visit with the anaesthesist prior to hospitalisation
  • Being capable of understanding the information note
  • Who gave a written informed consent
  • Affiliated to a medical insurance
  • Surgery in relation to alcohol consumption (chronic pancreatitis, oropharyngeal cancer for example) or modifying alcohol consumption (liver transplantation for example),
  • No telephone number
  • Dependence to alcohol (Alcohol Use Disorders Identification Test score ≥ 13)
  • History of alcohol weaning complications
  • History of addiction care
  • Life expectancy less than 5 years
  • Decompensated psychiatric disease
  • Usual consumption (more than three times a week) of illicit products
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unité d'Alcoologie et Hépatologie Générale, Département d'Anesthésie Réanimation- Hôpital de Pontchaillou

Rennes, 35033, France

Location

MeSH Terms

Conditions

AlcoholismAlcohol-Related Disorders

Interventions

EthanolMethods

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

AlcoholsOrganic ChemicalsInvestigative Techniques

Study Officials

  • Romain MOIRAND, MD, PhD

    Rennes University Hospital

    PRINCIPAL INVESTIGATOR

  • Jean-Michel REYMANN, PhD

    Rennes University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2010

First Posted

May 5, 2011

Study Start

July 1, 2010

Primary Completion

May 1, 2012

Study Completion

November 1, 2012

Last Updated

May 1, 2014

Record last verified: 2014-04

Locations

FR(1)