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

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ClinicalTrials.gov Identifier: NCT00226720
Recruitment Status : Completed
First Posted : September 27, 2005
Last Update Posted : May 6, 2008
Sponsor:
Collaborator:
Direction Générale de la Santé, France
Information provided by:
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).

Condition or disease Intervention/treatment Phase
Alcoholism Alcohol Dependence Procedure: Outpatient detoxification program Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Comparison of Efficacy of an Outpatient vs Inpatient Detoxification Program for Alcohol Dependent Patients Seeking Abstinence. A Prospective Randomized Clinical Trial.
Study Start Date : September 2002
Actual Primary Completion Date : November 2004
Actual Study Completion Date : November 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
at the hospital
Procedure: Outpatient detoxification program
Outpatient detoxification program
Active Comparator: 2
out of the hospital
Procedure: Outpatient detoxification program
Outpatient detoxification program



Primary Outcome Measures :
  1. 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. [ Time Frame: at 3 Months & 6 Months ]

Secondary Outcome Measures :
  1. 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. [ Time Frame: during the 6 months follow-up ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00226720


Locations
France
BEAUJON Hospital
Clichy, France, 92110
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Direction Générale de la Santé, France
Investigators
Principal Investigator: Philippe M. BATEL, MD Assistance Publique - Hôpitaux de Paris

Publications:

Responsible Party: Myriem TOUHAMI-CARRIER, Department Clinical Research of the Developpement
ClinicalTrials.gov Identifier: NCT00226720     History of Changes
Other Study ID Numbers: P000807
AOM98176
First Posted: September 27, 2005    Key Record Dates
Last Update Posted: May 6, 2008
Last Verified: April 2007

Keywords provided by Assistance Publique - Hôpitaux de Paris:
alcoholism
Alcohol dependence
Detoxification
Abstinence maintain
Efficacy
Ambulatory detoxification

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs