Comparative Trial Of Disulfiram, Naltrexone And Acamprosate In The Treatment Of Alcohol Dependence
DNA
Phase Four Randomized, Multicentre, Open-Label, Comparative Trial Of Disulfiram, Nalterexone And Acamprosate In The Treatment Of Alcohol Dependence
1 other identifier
interventional
243
1 country
1
Brief Summary
The aim of this study was to compare the effect of manual based cognitive therapy in adjunct of three different pharmacotherapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Sep 2000
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2000
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2005
CompletedFirst Submitted
Initial submission to the registry
February 14, 2007
CompletedFirst Posted
Study publicly available on registry
February 15, 2007
CompletedFebruary 16, 2007
February 1, 2000
February 14, 2007
February 15, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time(days) to first heavy drinking (HDD)day after medication started
Secondary Outcomes (8)
Time (days) to first drinking after medication started
Abstinence days (0 drinks/ day) by group
Average alcohol intake (weekly by group)
ALAT
GGT
- +3 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- Alcohol dependence (ICD-10)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Public Health Institute, Department of Mental Health and Alcohol Research
Helsinki, 00251, Finland
Related 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. doi: 10.1111/j.1360-0443.2006.01555.x.
PMID: 16968347BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Hannu Alho, MD, PhD
National Public Health Institute, Department of Mental health and Alcohol Research
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
February 14, 2007
First Posted
February 15, 2007
Study Start
September 1, 2000
Study Completion
April 1, 2005
Last Updated
February 16, 2007
Record last verified: 2000-02