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

Finnish Institute for Health and Welfare

Status and phase

Completed

Phase 4

Conditions

Alcohol Dependence

Treatments

Drug: Naltexone

Drug: Acamprosate

Drug: Disulfiram

Study type

Interventional

Funder types

Other

Identifiers

NCT00435435

KTL-175-1

Details and patient eligibility

About

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

Full 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.

Sex

All

Ages

25 to 65 years old

Volunteers

Accepts Healthy Volunteers

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