Alcohol Dependence, Alcoholism
Conditions
Keywords
alcoholism, Alcohol dependence, Detoxification, Abstinence maintain, Efficacy, Ambulatory detoxification
Brief summary
Detoxification, in an inpatient or outpatient program, is the primary and essential step for managing alcohol dependence. The superiority of one or other method of detoxification has never been proved in several previous randomized clinical trials (RCT). The aim of this multicenter RCT was to compare efficiency, on the abstinence rate as the primary outcome, at 1 and 3 months follow-up of two alcohol detoxification programs (a 5/7-days inpatient detox vs. an ambulatory detox).
Detailed description
Among patients consulting in 4 alcohol treatment centers in France seeking treatment for withdrawal, we included those who met criteria for current alcohol-dependence (DSM IV) and having drinking during the past three days before randomization. Exclusion criteria were: patients' refusal of one or other method, contraindication for outpatient detoxification method (history of DELIRIUM TREMENS or withdrawal seizures), homelessness, Major Depressive Episode assessed by MADRS \> 25, current Substance Abuse Disorder (except nicotine), indication for hospitalization (severe somatic disorder), judicial injunction, family crisis, patients seeking antabuse treatment.
Interventions
PROCEDUREOutpatient detoxification program
Outpatient detoxification program
Sponsors
Direction Générale de la Santé, France
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Alcohol dependence according to DSM IV * Detoxification program requested by patients
Exclusion criteria
* Refusal of the patient for the hospitalization or ambulant weaning alcoholic * contraindication in ambulant weaning * The state of the patient requires a hospitalization * Ask of the patient for a treatment by the ESPERAL
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Abstinence rate at 3 Months & 6 Months follow-up. Abstinence is defined as no alcohol drinking during the period between the last day of the detoxification program and the evaluation. | at 3 Months & 6 Months |
Secondary
| Measure | Time frame |
|---|---|
| Relapse rate. Relapse is defined as drinking more than 4 Units per occasion (3 for women) and more than one occasion per week during the 6 months follow-up after the last day of detoxification program. | during the 6 months follow-up |
Countries
France
Outcome results
None listed