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

Primary Purpose

Alcohol Dependence

Status
Completed
Phase
Phase 4
Locations
Finland
Study Type
Interventional
Intervention
Disulfiram
Acamprosate
Naltexone
Sponsored by
Finnish Institute for Health and Welfare
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Dependence focused on measuring Alcoholism, Dependence, Randomization, Effect, Disulfiram, Naltrexone, Acamprosate

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

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

Outcomes

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

Full Information

First Posted
February 14, 2007
Last Updated
February 15, 2007
Sponsor
Finnish Institute for Health and Welfare
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1. Study Identification

Unique Protocol Identification Number
NCT00435435
Brief Title
Comparative Trial Of Disulfiram, Naltrexone And Acamprosate In The Treatment Of Alcohol Dependence
Acronym
DNA
Official Title
Phase Four Randomized, Multicentre, Open-Label, Comparative Trial Of Disulfiram, Nalterexone And Acamprosate In The Treatment Of Alcohol Dependence
Study Type
Interventional

2. Study Status

Record Verification Date
February 2000
Overall Recruitment Status
Completed
Study Start Date
September 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Finnish Institute for Health and Welfare

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Dependence
Keywords
Alcoholism, Dependence, Randomization, Effect, Disulfiram, Naltrexone, Acamprosate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
243 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Disulfiram
Intervention Type
Drug
Intervention Name(s)
Acamprosate
Intervention Type
Drug
Intervention Name(s)
Naltexone
Primary Outcome Measure Information:
Title
Time(days) to first heavy drinking (HDD)day after medication started
Secondary Outcome Measure Information:
Title
Time (days) to first drinking after medication started
Title
Abstinence days (0 drinks/ day) by group
Title
Average alcohol intake (weekly by group)
Title
ALAT
Title
GGT
Title
SADD
Title
AUDIT
Title
EQ-5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hannu Alho, MD, PhD
Organizational Affiliation
National Public Health Institute, Department of Mental health and Alcohol Research
Official's Role
Study Director
Facility Information:
Facility Name
National Public Health Institute, Department of Mental Health and Alcohol Research
City
Helsinki
ZIP/Postal Code
00251
Country
Finland

12. IPD Sharing Statement

Citations:
PubMed Identifier
16968347
Citation
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. doi: 10.1111/j.1360-0443.2006.01555.x.
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Comparative Trial Of Disulfiram, Naltrexone And Acamprosate In The Treatment Of Alcohol Dependence

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