Outpatient Versus Inpatient Detoxification Program for Alcohol Dependent Patients Seeking Abstinence: The IN/OUT Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison of Efficacy of an Outpatient vs Inpatient Detoxification Program for Alcohol Dependent Patients Seeking Abstinence. A Prospective Randomized Clinical Trial.

Conditions
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Alcoholism, Alcohol Dependence

Intervention / Treatment
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* Procedure: Outpatient detoxification program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>at the hospital | Procedure: Outpatient detoxification program<br>* Outpatient detoxification program<br>|
| Active Comparator: 2<br>out of the hospital | Procedure: Outpatient detoxification program<br>* Outpatient detoxification program<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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alcoholism, Alcohol dependence, Detoxification, Abstinence maintain, Efficacy, Ambulatory detoxification