To determine the reduction in alcohol consumption in patients with alcohol dependence treated with 18 mg Selincro® as-needed use, in conjunction with continuous psychosocial support in primary care
635 patients are planned (total number of patients) with 475 patients treated with Selincro® (Cohort A) and 160 patients not treated with Selincro® (Cohort B) to determine the reduction in alcohol consumption in patients with alcohol dependence. Cohort A will comprise patients who maintain a high drinking risk level (DRL, defined by World Health Organization (WHO) as \>60g alcohol/day for a man or \>40g alcohol/day for a woman), or above, in the period between the Screening and Inclusion Visits. Cohort B will comprise patients who reduce their alcohol consumption in the period between the Screening and Inclusion visits, that is, patients who do not maintain at least a high DRL at the Inclusion Visit (and are therefore not eligible for treatment with nalmefene according to the SmPC).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
378
Change in the number of Heavy Drinking Days (HDDs) (days/month)
Cohort A
Time frame: Baseline to Month 3
Change in Total Alcohol Consumption (TAC) (g/day)
Cohort A
Time frame: Baseline to Month 3
Drinking Risk Level response (RSDRL); defined as a downward shift in Drinking Risk Level (DRL); for patients with a very high DRL at baseline, a shift to medium DRL or below; for patients with a high DRL at baseline, a shift to low DRL or below
Cohort A
Time frame: Baseline to Month 3
RLDRL response; defined as a downward shift in DRL to low DRL or below
Cohort A
Time frame: Baseline to Month 3
Response defined as ≥70% reduction in TAC
Cohort A
Time frame: Baseline to Month 3
Response defined as 0 to 4 HDDs (days/month)
Cohort A
Time frame: Month 3
Change in Clinical Global Impression - Severity of Illness (CGI-S) score
Cohort A
Time frame: Baseline to Week 12
Clinical Global Impression - Global Improvement (CGI-I)
Cohort A
Time frame: Week 12
y-glutamyl transferase (y-GT)
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FR010
Bécon-les-Granits, France
FR001
Bordeaux, France
FR005
Bordeaux, France
FR009
Cestas, France
FR012
Chauny, France
FR002
Coulounieix-Chamiers, France
FR008
La Teste-de-Buch, France
FR007
Mont-de-Marsan, France
FR011
Narbonne, France
FR003
Targon, France
...and 38 more locations
Cohort A
Time frame: Week 12
Alanine aminotransferase (ALT)
Cohort A
Time frame: Week 12
Aspartate aminotransferase (AST)
Cohort A
Time frame: Week 12
Change in 36-item Short-form Health Survey version 2 (SF-36) (only for patients in France and the United Kingdom)
Cohort A
Time frame: Baseline to Week 12