Outpatient Versus Inpatient Detoxification Program for Alcohol Dependent Patients Seeking Abstinence: The IN/OUT Study
5. maj 2008 opdateret af: Assistance Publique - Hôpitaux de Paris
Comparison of Efficacy of an Outpatient vs Inpatient Detoxification Program for Alcohol Dependent Patients Seeking Abstinence. A Prospective Randomized Clinical Trial.
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).
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
500
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Clichy, Frankrig, 92110
- Beaujon Hospital
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 1
at the hospital
|
Outpatient detoxification program
|
|
Aktiv komparator: 2
out of the hospital
|
Outpatient detoxification program
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
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.
Tidsramme: at 3 Months & 6 Months
|
at 3 Months & 6 Months
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
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.
Tidsramme: during the 6 months follow-up
|
during the 6 months follow-up
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Philippe M. BATEL, MD, Assistance Publique - Hôpitaux de Paris
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
- 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.
- Batel P, Balester-Mouret S. [Care network in addictive pathologies: where is it?]. Rev Prat. 2003 Jun 15;53(12):1335-9. French.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Batel P, Lariviere P. [Late-onset alcohol withdrawal syndrome]. Ann Med Interne (Paris). 2000 Oct;151 Suppl B:B27-9. French.
- 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.
- Batel P. Addiction and schizophrenia. Eur Psychiatry. 2000 Mar;15(2):115-22. doi: 10.1016/s0924-9338(00)00203-0.
- 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.
- Batel P. [Alcohol withdrawal syndrome in the hospital]. Rev Prat. 1999 Feb 15;49(4):387-90. French.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. september 2002
Primær færdiggørelse (Faktiske)
1. november 2004
Studieafslutning (Faktiske)
1. november 2004
Datoer for studieregistrering
Først indsendt
23. september 2005
Først indsendt, der opfyldte QC-kriterier
23. september 2005
Først opslået (Skøn)
27. september 2005
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
6. maj 2008
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
5. maj 2008
Sidst verificeret
1. april 2007
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- P000807
- AOM98176
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .