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

NCT00226720 | Completed

• 2 other identifiers: P000807AOM98176
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Alcoholism; Alcohol Dependence

Keywords

alcoholism; Alcohol dependence; Detoxification; Abstinence maintain; Efficacy; Ambulatory detoxification

Outcome Measures

Primary Outcomes (1)

• 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.

  at 3 Months & 6 Months

Secondary Outcomes (1)

• 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.

  during the 6 months follow-up

Study Arms (2)

1

EXPERIMENTAL

at the hospital

Procedure: Outpatient detoxification program

2

ACTIVE COMPARATOR

out of the hospital

Procedure: Outpatient detoxification program

Interventions

Outpatient detoxification program PROCEDURE

Outpatient detoxification program

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Alcohol dependence according to DSM IV
• Detoxification program requested by patients

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Direction Générale de la Santé, France: collaborator

Study Sites (1)

BEAUJON Hospital

Clichy, 92110, France

Location

Related Publications (20)

• 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.

  PMID: 15935433 BACKGROUND

• 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.

  PMID: 15617169 BACKGROUND

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

  PMID: 12920943 BACKGROUND

• 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.

  PMID: 12640727 BACKGROUND

• 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.

  PMID: 12513948 BACKGROUND

• 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.

  PMID: 12218879 BACKGROUND

• 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.

  PMID: 12068283 BACKGROUND

• 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.

  PMID: 11827742 BACKGROUND

• 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.

  PMID: 11762133 BACKGROUND

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

  PMID: 11104941 BACKGROUND

• 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.

  PMID: 10960156 BACKGROUND

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

  PMID: 10881208 BACKGROUND

• 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.

  PMID: 10881204 BACKGROUND

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

  PMID: 10319688 BACKGROUND

• 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.

  PMID: 9408207 BACKGROUND

• 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.

  PMID: 9071895 BACKGROUND

• 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.

  PMID: 8528027 BACKGROUND

• 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.

  PMID: 8565793 BACKGROUND

• 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.

  PMID: 7663320 BACKGROUND

• 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.

  PMID: 7633298 BACKGROUND

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Philippe M. BATEL, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 23, 2005
• First Posted: September 27, 2005
• Study Start: September 1, 2002
• Primary Completion: November 1, 2004
• Study Completion: November 1, 2004
• Last Updated: May 6, 2008

Record last verified: 2007-04

Locations

FR (1)