Trials / Completed
CompletedNCT00226720
Outpatient Versus Inpatient Detoxification Program for Alcohol Dependent Patients Seeking Abstinence: The IN/OUT Study
Comparison of Efficacy of an Outpatient vs Inpatient Detoxification Program for Alcohol Dependent Patients Seeking Abstinence. A Prospective Randomized Clinical Trial.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 500 (actual)
- Sponsor
- Assistance Publique - Hôpitaux de Paris · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Outpatient detoxification program | Outpatient detoxification program |
Timeline
- Start date
- 2002-09-01
- Primary completion
- 2004-11-01
- Completion
- 2004-11-01
- First posted
- 2005-09-27
- Last updated
- 2008-05-06
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT00226720. Inclusion in this directory is not an endorsement.