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

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 |
- 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 ]
- 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, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
France | |
BEAUJON Hospital | |
Clichy, France, 92110 |
Principal Investigator: | Philippe M. BATEL, MD | Assistance Publique - Hôpitaux de Paris |
Responsible Party: | Myriem TOUHAMI-CARRIER, Department Clinical Research of the Developpement |
ClinicalTrials.gov Identifier: | NCT00226720 |
Other Study ID Numbers: |
P000807 AOM98176 |
First Posted: | September 27, 2005 Key Record Dates |
Last Update Posted: | May 6, 2008 |
Last Verified: | April 2007 |
alcoholism Alcohol dependence Detoxification |
Abstinence maintain Efficacy Ambulatory detoxification |
Alcoholism Alcohol-Related Disorders Substance-Related Disorders Chemically-Induced Disorders Mental Disorders |