Alcohol Dependence
Conditions
Keywords
Alcoholism, Dependence, Randomization, Effect, Disulfiram, Naltrexone, Acamprosate
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.
Interventions
DRUGDisulfiram
DRUGAcamprosate
DRUGNaltexone
Sponsors
Finnish Institute for Health and Welfare
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time(days) to first heavy drinking (HDD)day after medication started | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Finland
Outcome results
None listed