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

Alcohol Dependence Clinical Trial

— DNA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00435435
• Other study ID #: KTL-175-1
• Status: Completed
• Phase: Phase 4
• First received: February 14, 2007
• Last updated: February 15, 2007
• Start date: September 2000
• Est. completion date: April 2005

Study information

• Verified date: February 2000
• Source: National Institute for Health and Welfare, Finland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 243
• Est. completion date: April 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcohol Dependence
• Alcoholism

Intervention

Drug:
• Disulfiram

• Acamprosate

• Naltexone

Locations

Country	Name	City	State
Finland	National Public Health Institute, Department of Mental Health and Alcohol Research	Helsinki

Sponsors (1)

Lead Sponsor	Collaborator
National Institute for Health and Welfare, Finland

Country where clinical trial is conducted

Finland, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time(days) to first heavy drinking (HDD)day after medication started
Secondary	Time (days) to first drinking after medication started
Secondary	Abstinence days (0 drinks/ day) by group
Secondary	Average alcohol intake (weekly by group)
Secondary	ALAT
Secondary	GGT
Secondary	SADD
Secondary	AUDIT
Secondary	EQ-5