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

NCT ID: NCT00226720

Last Updated: 2008-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-09-30

Study Completion Date

2004-11-30

Brief Summary

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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

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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.

Conditions

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Alcoholism Alcohol Dependence

Keywords

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alcoholism Alcohol dependence Detoxification Abstinence maintain Efficacy Ambulatory detoxification

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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1

at the hospital

Group Type EXPERIMENTAL

Outpatient detoxification program

Intervention Type PROCEDURE

Outpatient detoxification program

2

out of the hospital

Group Type ACTIVE_COMPARATOR

Outpatient detoxification program

Intervention Type PROCEDURE

Outpatient detoxification program

Interventions

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Outpatient detoxification program

Outpatient detoxification program

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Direction Générale de la Santé, France

OTHER

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Department Clinical Research of the Developpement

Principal Investigators

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Philippe M. BATEL, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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BEAUJON Hospital

Clichy, , France

Site Status

Countries

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France

References

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Limosin F, Romo L, Batel P, Ades J, Boni C, Gorwood P. Association between dopamine receptor D3 gene BalI polymorphism and cognitive impulsiveness in alcohol-dependent men. Eur Psychiatry. 2005 May;20(3):304-6. doi: 10.1016/j.eurpsy.2005.02.004.

Reference Type BACKGROUND
PMID: 15935433 (View on PubMed)

Batel P, Reynaud-Maurupt C, Lavignasse P, Constant MV, Kopp P, Jourdain JJ, Videau B, Mucchielli A, Riff B, Lowenstein W. [Risk factors of early drop-out during induction of high-dose buprenorphine substitution therapy. A study of 1085 opiate addicts]. Presse Med. 2004 Oct 23;33(18 Suppl):5-9. doi: 10.1016/s0755-4982(04)72375-1. French.

Reference Type BACKGROUND
PMID: 15617169 (View on PubMed)

Batel P, Balester-Mouret S. [Care network in addictive pathologies: where is it?]. Rev Prat. 2003 Jun 15;53(12):1335-9. French.

Reference Type BACKGROUND
PMID: 12920943 (View on PubMed)

Pessione F, Ramond MJ, Peters L, Pham BN, Batel P, Rueff B, Valla DC. Five-year survival predictive factors in patients with excessive alcohol intake and cirrhosis. Effect of alcoholic hepatitis, smoking and abstinence. Liver Int. 2003 Feb;23(1):45-53. doi: 10.1034/j.1600-0676.2003.01804.x.

Reference Type BACKGROUND
PMID: 12640727 (View on PubMed)

Gorwood P, Limosin F, Batel P, Hamon M, Ades J, Boni C. The A9 allele of the dopamine transporter gene is associated with delirium tremens and alcohol-withdrawal seizure. Biol Psychiatry. 2003 Jan 1;53(1):85-92. doi: 10.1016/s0006-3223(02)01440-3.

Reference Type BACKGROUND
PMID: 12513948 (View on PubMed)

Lavignasse P, Lowenstein W, Batel P, Constant MV, Jourdain JJ, Kopp P, Reynaud-Maurupt C, Riff B, Videau B, Mucchielli A. Economic and social effects of high-dose buprenorphine substitution therapy. Six-month results. Ann Med Interne (Paris). 2002 May;153(3 Suppl):1S20-6.

Reference Type BACKGROUND
PMID: 12218879 (View on PubMed)

Batel P, Michaud P. [Risky alcohol drinking or problems and brief interventions]. Gastroenterol Clin Biol. 2002 May;26(5 Suppl):B158-62. No abstract available. French.

Reference Type BACKGROUND
PMID: 12068283 (View on PubMed)

Gorwood P, Aissi F, Batel P, Ades J, Cohen-Salmon C, Hamon M, Boni C, Lanfumey L. Reappraisal of the serotonin 5-HT(1B) receptor gene in alcoholism: of mice and men. Brain Res Bull. 2002 Jan 1;57(1):103-7. doi: 10.1016/s0361-9230(01)00641-4.

Reference Type BACKGROUND
PMID: 11827742 (View on PubMed)

Gorwood P, Limosin F, Batel P, Duaux E, Gouya L, Ades J. The genetics of addiction: alcohol-dependence and D3 dopamine receptor gene. Pathol Biol (Paris). 2001 Nov;49(9):710-7. doi: 10.1016/s0369-8114(01)00236-x.

Reference Type BACKGROUND
PMID: 11762133 (View on PubMed)

Batel P, Lariviere P. [Late-onset alcohol withdrawal syndrome]. Ann Med Interne (Paris). 2000 Oct;151 Suppl B:B27-9. French.

Reference Type BACKGROUND
PMID: 11104941 (View on PubMed)

Gorwood P, Batel P, Ades J, Hamon M, Boni C. Serotonin transporter gene polymorphisms, alcoholism, and suicidal behavior. Biol Psychiatry. 2000 Aug 15;48(4):259-64. doi: 10.1016/s0006-3223(00)00840-4.

Reference Type BACKGROUND
PMID: 10960156 (View on PubMed)

Batel P. Addiction and schizophrenia. Eur Psychiatry. 2000 Mar;15(2):115-22. doi: 10.1016/s0924-9338(00)00203-0.

Reference Type BACKGROUND
PMID: 10881208 (View on PubMed)

Gorwood P, Batel P, Gouya L, Courtois F, Feingold J, Ades J. Reappraisal of the association between the DRD2 gene, alcoholism and addiction. Eur Psychiatry. 2000 Mar;15(2):90-6. doi: 10.1016/s0924-9338(00)00207-8.

Reference Type BACKGROUND
PMID: 10881204 (View on PubMed)

Batel P. [Alcohol withdrawal syndrome in the hospital]. Rev Prat. 1999 Feb 15;49(4):387-90. French.

Reference Type BACKGROUND
PMID: 10319688 (View on PubMed)

Quinones-Jenab V, Batel P, Schlussman SD, Ho A, Kreek MJ. Cocaine impairs maternal nest building in pregnant rats. Pharmacol Biochem Behav. 1997 Dec;58(4):1009-13. doi: 10.1016/s0091-3057(97)00311-0.

Reference Type BACKGROUND
PMID: 9408207 (View on PubMed)

Batel-Copel LM, Kornblith AB, Batel PC, Holland JC. Do oncologists have an increasing interest in the quality of life of their patients? A literature review of the last 15 years. Eur J Cancer. 1997 Jan;33(1):29-32. doi: 10.1016/s0959-8049(96)00414-5.

Reference Type BACKGROUND
PMID: 9071895 (View on PubMed)

Batel P. A critique of chapter 3: "Individual drinking and degree of risk". Addiction. 1995 Nov;90(11):1450-1. doi: 10.1111/j.1360-0443.1995.tb02804.x. No abstract available.

Reference Type BACKGROUND
PMID: 8528027 (View on PubMed)

Batel P. The treatment of alcoholism in France. Drug Alcohol Depend. 1995 Sep;39 Suppl 1:S15-21. doi: 10.1016/0376-8716(95)01169-y.

Reference Type BACKGROUND
PMID: 8565793 (View on PubMed)

Batel P, Pessione F, Maitre C, Rueff B. Relationship between alcohol and tobacco dependencies among alcoholics who smoke. Addiction. 1995 Jul;90(7):977-80. doi: 10.1046/j.1360-0443.1995.90797711.x.

Reference Type BACKGROUND
PMID: 7663320 (View on PubMed)

Batel P, Pessione F, Bouvier AM, Rueff B. Prompting alcoholics to be referred to an alcohol clinic: the effectiveness of a simple letter. Addiction. 1995 Jun;90(6):811-4. doi: 10.1046/j.1360-0443.1995.9068118.x.

Reference Type BACKGROUND
PMID: 7633298 (View on PubMed)

Other Identifiers

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AOM98176

Identifier Type: -

Identifier Source: secondary_id

P000807

Identifier Type: -

Identifier Source: org_study_id