Comparative Trial Of Disulfiram, Naltrexone And Acamprosate In The Treatment Of Alcohol Dependence (DNA)
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|ClinicalTrials.gov Identifier: NCT00435435|
Recruitment Status : Completed
First Posted : February 15, 2007
Last Update Posted : February 16, 2007
|Condition or disease||Intervention/treatment||Phase|
|Alcohol Dependence||Drug: Disulfiram Drug: Acamprosate Drug: Naltexone||Phase 4|
Context Alcoholism is common clinical problem and its treatment has no standard and is controversy. Different pharmacotherapy's, acamporsate, nalterxone and disulfiram have shown to improve the drinking outcomes, but there is no randomized comparative studies on the effects of these three medications.
Objectives The aim of this study was to compare the effect of manual based cognitive therapy in adjunct of three different pharmacotherapy.
Design and setting Randomized, open label, multicentre naturalistic study, 12 week continuous medication followed by targeted medication up to 52weeks and 67 week follow up on voluntary treatment seeking alcohol dependent outpatients.
Participants 243 alcohol dependent adults. Intervention Subjects were randomized 1:1:1 to receive naltrexone, acamprosate or disulfiram, 50 mg, 1998 mg or 200 mg correspondingly per day. The patients were met weekly in first month, then after 3, 6 and 12 months.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||243 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase Four Randomized, Multicentre, Open-Label, Comparative Trial Of Disulfiram, Nalterexone And Acamprosate In The Treatment Of Alcohol Dependence|
|Study Start Date :||September 2000|
|Study Completion Date :||April 2005|
- Time(days) to first heavy drinking (HDD)day after medication started
- Time (days) to first drinking after medication started
- Abstinence days (0 drinks/ day) by group
- Average alcohol intake (weekly by group)
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): NCT00435435
|National Public Health Institute, Department of Mental Health and Alcohol Research|
|Helsinki, Finland, 00251|
|Study Director:||Hannu Alho, MD, PhD||National Public Health Institute, Department of Mental health and Alcohol Research|