Comparative Trial Of Disulfiram, Naltrexone And Acamprosate In The Treatment Of Alcohol Dependence - Tabular View

Tracking Information

First Received Date ^ICMJE

February 14, 2007

Last Updated Date

February 15, 2007

Start Date ^ICMJE

September 2000

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Time(days) to first heavy drinking (HDD)day after medication started

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00435435 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Time (days) to first drinking after medication started
Abstinence days (0 drinks/ day) by group
Average alcohol intake (weekly by group)
ALAT
GGT
SADD
AUDIT
EQ-5

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Comparative Trial Of Disulfiram, Naltrexone And Acamprosate In The Treatment Of Alcohol Dependence

Official Title ^ICMJE

Phase Four Randomized, Multicentre, Open-Label, Comparative Trial Of Disulfiram, Nalterexone And Acamprosate In The Treatment Of Alcohol Dependence

Brief Summary

The aim of this study was to compare the effect of manual based cognitive therapy in adjunct of three different pharmacotherapy.

Detailed Description

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 Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Alcohol Dependence

Intervention ^ICMJE

Drug: Disulfiram
Drug: Acamprosate
Drug: Naltexone

Study Arms / Comparison Groups

Publications *

Morley KC, Teesson M, Reid SC, Sannibale C, Thomson C, Phung N, Weltman M, Bell JR, Richardson K, Haber PS. Naltrexone versus acamprosate in the treatment of alcohol dependence: A multi-centre, randomized, double-blind, placebo-controlled trial. Addiction. 2006 Oct;101(10):1451-62.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

243

Completion Date

April 2005

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Alcohol dependence (ICD-10)

Exclusion Criteria:

Clinically significant symptoms of alcohol withdrawal
Significant recently diagnosed psychiatric disease (psychosis, personality disorder or suicidal tendency that appeared during the initial interview)
Current psychiatric disease demanding special treatment or medication including DSM-IV determined drug dependence other than alcohol or nicotine dependence
Current use of any opioids within four weeks before screening
Significant brain, thyroid, kidney, uncompensated heart disease, or clinically significant liver disease (cirrhosis, aqlcoholic hepatitis or ALAT > 200)
Pregnancy, nursing, or women refused to use a reliable method for birth control

Gender

Both

Ages

25 Years to 65 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Finland

Administrative Information

NCT ID ^ICMJE

NCT00435435

Responsible Party

Study ID Numbers ^ICMJE

KTL-175-1

Study Sponsor ^ICMJE

National Institute for Health and Welfare, Finland

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Hannu Alho, MD, PhD

National Public Health Institute, Department of Mental health and Alcohol Research

Information Provided By

National Institute for Health and Welfare, Finland

Verification Date

February 2000

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP