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

Not Applicable

Completed

• Conditions: Alcoholism; Alcohol Dependence
• Interventions: Procedure: Outpatient detoxification program

• Registration Number: NCT00226720
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study Start: 2002-09
• Primary Completion: 2004-11
• Study Completion: 2004-11
• Study First Submitted: 2005-09-23
• Study First Submitted QC: 2005-09-23
• Study First Posted: 2005-09-27
• Status Verified: 2007-04
• Last Update Submitted: 2008-05-05
• Last Update Posted: 2008-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Alcohol dependence according to DSM IV
• Detoxification program requested by patients

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Outpatient detoxification program	at the hospital
2	Outpatient detoxification program	out of the hospital

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

BEAUJON Hospital; 🇫🇷 Clichy, France