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Completed

NCT Number: NCT00435435

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

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

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Key information

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Helsinki, 00251, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Disulfiram

Drug

acamprosate

Drug

Naltexone

Drug

Primary outcomes

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

Secondary outcomes

  1. Time (days) to first drinking after medication started

  2. Abstinence days (0 drinks/ day) by group

  3. Average alcohol intake (weekly by group)

  4. ALAT

  5. GGT

  6. SADD

  7. AUDIT

  8. EQ-5

Sponsors and collaborators

Lead sponsor

Finnish Institute for Health and Welfare

Other Gov

Registry information

Official study title

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

Acronym: DNA

Important dates

Study start
2000
Study completion
2005
First posted
Feb 15, 2007
Registry last updated
Feb 16, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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