Alcohol Abuse Clinical Trial
— ITBCHIROfficial title:
Efficacy of a Brief Alcohol Intervention for Non Dependant Alcohol-misusing Patients Undergoing a Scheduled Surgery: a Randomized Controlled Trial
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.
Status | Terminated |
Enrollment | 3 |
Est. completion date | November 2012 |
Est. primary completion date | May 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 30 Years to 75 Years |
Eligibility |
Inclusion Criteria: - 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 Non inclusion Criteria: - 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 - Person deprived of freedom or under guardianship - Participation or intent to participate in another biomedical research |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
France | Unité d'Alcoologie et Hépatologie Générale, Département d'Anesthésie Réanimation- Hôpital de Pontchaillou | Rennes |
Lead Sponsor | Collaborator |
---|---|
Rennes University Hospital | Ministry of Health, France |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of patients getting back to an Alcohol Use Disorders Identification Test score <7 | 1 year | No | |
Secondary | Evolution of the Alcohol Use Disorders Identification Test score | 1 year | No | |
Secondary | Alcohol consumption in the month preceding the final evaluation at 1 year | 1 year | No | |
Secondary | Gamma-GT and CDT evolution | 1 year | No | |
Secondary | Frequency of normalization of gamma-GT and CDT measures | 1 year | No | |
Secondary | 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 | No | |
Secondary | Feeling of the patients towards the Brief Alcohol Intervention | recollection, acceptability, relevance, recollection of the recall at 3 months, acceptability of the recall at 3 months | 1 year | No |
Secondary | Prevalence of alcohol misuse, with or without dependence, in patients seen in pre-anaesthesia consultation | 6 months | No | |
Secondary | Proportion of total population presenting an increase in gamma-GT and CDT in comparison with upper limits of normal | 6 months | No |
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