The varenicline for alcohol dependence trial investigates the efficacy of varenicline versus placebo for maintaining abstinence in the postacute treatment of alcohol dependent subjects. The main study hypothesis is that subjects treated with varenicline have more abstinent days during the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
40
Varenicline 0,5mg daily on day 1-3, Varenicline 1mg daily on day 4-7 and Varenicline 2mg on day 8-84.
Placebo
Department of psychiatry, psychosomatics and psychotherapie, Markus hospital, Frankfurt am Main
Frankfurt am Main, Hesse, Germany
RECRUITINGDepartment of psychiatry and psychotherapy, University medical center of the Johannes Gutenberg.university Mainz
Mainz, Rhineland-Palatinate, Germany
RECRUITINGNumber of total alcohol abstinent days during he 12 weeks study period, percentage of the treatment days
Time frame: 12 weeks
Time in days to first alcoholic drink, assessed by the time-line-follow-back-interview
Time frame: 12 weeks
Proportion of abstinent patients during the study, percentage of all patients
Time frame: 12 weeks
Number of standard drinks per drinking day, assessed by the time-line-follow-back-interview.
Time frame: 12 weeks
Time in days to first heavy drinking, assessed by the time-line-follow-back-interview.
Time frame: 12 weeks
Number of days with heavy drinking as percentage of all treatment days, assessed by time-line-follow-back-interview.
Time frame: 12 weeks
Changes in gamma-glutamyl transpeptidase levels
Time frame: 12 weeks
Occurrence of adverse events
Time frame: 12 weeks
Compliance of the subjects
Time frame: 12 weeks
alcohol craving assessed by the obsessive compulsive drinking scale (OCDS) and a visual analog scale (VAS)
Time frame: 12 weeks
Severity of the alcohol dependence assessed by the European Addiction Severity Index (EuropASI)
Markus Dr. Lorscheider, clinical coordinator
CONTACT
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Time frame: 12 weeks
Absolute change in the Clinical Global Impression of Change (CGI)
Time frame: 12 weeks
Quality of life, assessed by the questionnaire for health condition Fragebogen zum allgemeinen Gesundheitszustand (SF-12)
Time frame: 12 weeks
Number of cigarettes per day
Time frame: 12 weeks
Number of nicotine abstinent days, percentage of the treatment days
Time frame: 12 weeks
Severity of the nicotine dependence, assessed by the Fagerstrom test for nicotine dependence
Time frame: 12 weeks
Intensity of depressive symptoms, assessed by the Beck Depression Inventors (BDI)
Time frame: 12 weeks