Clinical trial NCT00435435: Comparative Trial Of Disulfiram, Naltrexone And Acamprosate In The Treatment Of Alcohol Dependence
Official title: Phase Four Randomized, Multicentre, Open-Label, Comparative Trial Of Disulfiram, Nalterexone And Acamprosate In The Treatment Of Alcohol Dependence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Alcohol Dependence
Keywords: Alcoholism
Dependence
Randomization
Effect
Disulfiram
Naltrexone
Acamprosate
Lead sponsor: Finnish Institute for Health and Welfare
Sponsor class: OTHER_GOV
First posted: 2007-02-15
Enrollment: 243
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Time(days) to first heavy drinking (HDD)day after medication started
Secondary outcomes:
measure: Time (days) to first drinking after medication started
measure: Abstinence days (0 drinks/ day) by group
measure: Average alcohol intake (weekly by group)
measure: ALAT
measure: GGT
measure: SADD
measure: AUDIT
measure: EQ-5
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: National Public Health Institute, Department of Mental Health and Alcohol Research
Study officials:
affiliation: National Public Health Institute, Department of Mental health and Alcohol Research
name: Hannu Alho, MD, PhD
role: STUDY_DIRECTOR
References:
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.