ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00435435
Recruitment Status : Completed
First Posted : February 15, 2007
Last Update Posted : February 16, 2007
Sponsor:
Information provided by:
National Institute for Health and Welfare, Finland

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

Condition or disease Intervention/treatment Phase
Alcohol Dependence Drug: Disulfiram Drug: Acamprosate Drug: Naltexone Phase 4

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 Type : Interventional  (Clinical Trial)
Enrollment : 243 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase Four Randomized, Multicentre, Open-Label, Comparative Trial Of Disulfiram, Nalterexone And Acamprosate In The Treatment Of Alcohol Dependence
Study Start Date : September 2000
Study Completion Date : April 2005

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Time(days) to first heavy drinking (HDD)day after medication started

Secondary Outcome Measures :
  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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
ClinicalTrials.gov Identifier: NCT00435435     History of Changes
Other Study ID Numbers: KTL-175-1
First Posted: February 15, 2007    Key Record Dates
Last Update Posted: February 16, 2007
Last Verified: February 2000

Keywords provided by National Institute for Health and Welfare, Finland:
Alcoholism
Dependence
Randomization
Effect
Disulfiram
Naltrexone
Acamprosate

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Naltrexone
Acamprosate
Disulfiram
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Alcohol Deterrents
Acetaldehyde Dehydrogenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action