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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00435435 |
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Date of registration:
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14/02/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Comparative Trial Of Disulfiram, Naltrexone And Acamprosate In The Treatment Of Alcohol Dependence
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Scientific title:
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Phase Four Randomized, Multicentre, Open-Label, Comparative Trial Of Disulfiram, Nalterexone And Acamprosate In The Treatment Of Alcohol Dependence |
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Date of first enrolment:
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September 2000 |
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Target sample size:
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243 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00435435 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Finland
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Contacts
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Name:
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Hannu Alho, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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National Public Health Institute, Department of Mental health and Alcohol Research |
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Key inclusion & exclusion criteria
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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
Age minimum:
25 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Alcohol Dependence
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Intervention(s)
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Drug: Disulfiram
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Drug: Naltexone
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Drug: Acamprosate
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Primary Outcome(s)
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Time(days) to first heavy drinking (HDD)day after medication started
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Secondary Outcome(s)
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Average alcohol intake (weekly by group)
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AUDIT
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Abstinence days (0 drinks/ day) by group
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ALAT
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Time (days) to first drinking after medication started
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EQ-5
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GGT
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SADD
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Secondary ID(s)
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KTL-175-1
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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