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

This study has been completed.
Sponsor:
Collaborator:
Direction Générale de la Santé, France
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00226720
First received: September 23, 2005
Last updated: May 5, 2008
Last verified: April 2007
  Purpose

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
Alcoholism
Alcohol Dependence
Procedure: Outpatient detoxification program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

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
Experimental: 1
at the hospital
Procedure: Outpatient detoxification program
Outpatient detoxification program
Other Name: Outpatient detoxification program
Active Comparator: 2
out of the hospital
Procedure: Outpatient detoxification program
Outpatient detoxification program
Other Name: Outpatient detoxification program

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

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
Study First Received: September 23, 2005
Last Updated: May 5, 2008
Health Authority: France: Ministry of Health

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

ClinicalTrials.gov processed this record on July 31, 2014