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

Sponsor:	National Institute for Health and Welfare, Finland
Information provided by:	National Institute for Health and Welfare, Finland
ClinicalTrials.gov Identifier:	NCT00435435

Purpose

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

Condition	Intervention	Phase
Alcohol Dependence	Drug: Disulfiram Drug: Acamprosate Drug: Naltexone	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study
Official Title:	Phase Four Randomized, Multicentre, Open-Label, Comparative Trial Of Disulfiram, Nalterexone And Acamprosate In The Treatment Of Alcohol Dependence

Resource links provided by NLM:

MedlinePlus related topics: Alcoholism

Drug Information available for: Ethanol Naltrexone Acamprosate calcium Acamprosate Disulfiram

U.S. FDA Resources

Further study details as provided by National Institute for Health and Welfare, Finland:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	243
Study Start Date:	September 2000
Estimated Study Completion Date:	April 2005

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.

Eligibility

Ages Eligible for Study:	25 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00435435

Locations

Finland
National Public Health Institute, Department of Mental Health and Alcohol Research
Helsinki, Finland, 00251

Sponsors and Collaborators

National Institute for Health and Welfare, Finland

Investigators

Study Director:

Hannu Alho, MD, PhD

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

More Information

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.

Study ID Numbers:	KTL-175-1
Study First Received:	February 14, 2007
Last Updated:	February 15, 2007
ClinicalTrials.gov Identifier:	NCT00435435 History of Changes
Health Authority:	Finland: Finnish Medicines Agency

Keywords provided by National Institute for Health and Welfare, Finland:

Alcoholism
Dependence
Randomization
Effect

Disulfiram
Naltrexone
Acamprosate

Additional relevant MeSH terms:

Disulfiram
Molecular Mechanisms of Pharmacological Action
Disorders of Environmental Origin
Enzyme Inhibitors
Pharmacologic Actions
Acamprosate
Mental Disorders

Therapeutic Uses
Alcoholism
Substance-Related Disorders
Alcohol-Related Disorders
Central Nervous System Agents
Alcohol Deterrents

ClinicalTrials.gov processed this record on November 22, 2009