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Sponsors and Collaborators: |
Assistance Publique - Hôpitaux de Paris Direction Générale de la Santé |
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Information provided by: | Assistance Publique - Hôpitaux de Paris |
ClinicalTrials.gov Identifier: | NCT00226720 |
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 | Intervention |
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Alcoholism Alcohol Dependence |
Procedure: Outpatient detoxification program |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Comparison of Efficacy of an Outpatient vs Inpatient Detoxification Program for Alcohol Dependent Patients Seeking Abstinence. A Prospective Randomized Clinical Trial. |
Enrollment: | 500 |
Study Start Date: | September 2002 |
Study Completion Date: | November 2004 |
Primary Completion Date: | November 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
at the hospital
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Procedure: Outpatient detoxification program
Outpatient detoxification program
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2: Active Comparator
out of the hospital
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Procedure: Outpatient detoxification program
Outpatient detoxification program
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
France | |
BEAUJON Hospital | |
CLICHY, France, 92110 |
Principal Investigator: | Philippe M. BATEL, MD | Assistance Publique - Hôpitaux de Paris |
Responsible Party: | Department Clinical Research of the Developpement ( Myriem TOUHAMI-CARRIER ) |
Study ID Numbers: | P000807, AOM98176 |
Study First Received: | September 23, 2005 |
Last Updated: | May 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00226720 |
Health Authority: | France: Ministry of Health |
alcoholism Alcohol dependence Detoxification |
Abstinence maintain Efficacy Ambulatory detoxification |
Mental Disorders Alcoholism Benzocaine Substance-Related Disorders |
Disorders of Environmental Origin Alcohol-Related Disorders Ethanol |