Alcohol Dependency MedDRA version: 16.1 Level: SOC Classification code 10037175 Term: Psychiatric disorders System Organ Class: 10037175 - Psychiatric disorders MedDRA version: 16.1 Level: LLT Classification code 10001594 Term: Alcohol dependence syndrome System Organ Class: 10037175 - Psychiatric disorders
Conditions
Sponsors
H. Lundbeck A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • The patient has alcohol dependence diagnosed according to ICD-10. • The patient has had a high Drinking Risk Level (DRL; defined by WHO as >60g alcohol/day for a man or >40g alcohol/day for a woman) in the 4 weeks preceding the Screening Visit. • The patient is a man or woman, aged =18 years. • The patient provides a stable address and telephone number. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 620 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: • The patient has one or more contraindications to the prescription of Selincro®: a. hypersensitivity to the active substance or to any of the excipients, b. taking opioid analgesics, c. current or recent opioid addiction, d. acute symptoms of opioid withdrawal, e. recent use of opioids suspected, f. severe hepatic impairment (Child-Pugh classification), g. severe renal impairment (eGFR 60g for men or >40g for women) in the 4 weeks preceding the Screening Visit. • The patient has physical alcohol withdrawal symptoms and requires immediate detoxification for which inpatient treatment is required. • The patient is currently participating or has recently (in the 4 weeks preceding the Screening Visit) participated in a treatment or support programme for alcohol-use disorders, including Alcohol Anonymous, detoxification treatment, and treatment of alcohol withdrawal symptoms, or the patient is already taking nalmefene or has taken nalmefene in the 6 months preceding the Screening Visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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 (Cohort A).;Secondary Objective: -To evaluate the change in patients treated with 18 mg Selincro®, as-needed use, on clinical status, liver function, quality of life. -To determine the reduction in alcohol consumption in patients with alcohol dependence who reduce their alcohol consumption to below a high drinking risk level (according to WHO) in the screening period (and are therefore not eligible for Selincro® (nalmefene) treatment according to the Summary of Product Characteristics (SmPC)) (Cohort B). -To evaluate the psychometric properties of the Alcohol Quality of Life Scale (AQoLS). -To evaluate the safety and tolerability of 18 mg Selincro®, as-needed use, in primary care.;Primary end point(s): Primary Outcome Measure: • Change in the number of Heavy Drinking Days (HDDs) (days/month) [Cohort A];Timepoint(s) of evaluation of this end point: Primary Outcome Measure: • Change in the number of Heavy Drinking Days (HDDs) (days/month) [Cohort A] Time Frame: Baseline to Month 3 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Outcome Measures: • Change in Total Alcohol Consumption (TAC) (g/day) [Cohort A] • 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] • RLDRL response; defined as a downward shift in DRL to low DRL or below [Cohort A] • Response defined as =70% reduction in TAC Month 3 [Cohort A] • Response defined as 0 to 4 HDDs (days/month) [Cohort A] • Change in Clinical Global Impression - Severity of Illness (CGI-S) score [Cohort A] • Clinical Global Impression - Global Improvement (CGI-I) [Cohort A] • y-glutamyl transferase (y-GT) [Cohort A] • Alanine aminotransferase (ALT) [Cohort A] • Aspartate aminotransferase (AST) [Cohort A] • Change in 36-item Short-form Health Survey version 2 (SF-36) (only for patients in France and the United Kingdom) [Cohort A] • Change in Alcohol Quality of Life Scale (AQoLS) (only for patients in France and the United Kingdom) [Cohort A] • Change in the number of HDDs (days/month) [Cohort B] • Change in TAC (g/day) [Cohort B] • Adverse events [Cohorts A and B];Timepoint(s) of evaluation of this end point: Secondary Outcome Measures: • Change in TAC [Cohort A] - Baseline to Month 3 • RSDRL [Cohort A] - Baseline to Month 3 • RLDRL [Cohort A] - Baseline to Month 3] • Response: =70% reduction in TAC [Cohort A] - Baseline to Month 3 • Response: 0 to 4 HDDs (days/month) [Cohort A] - Month 3 • CGI-S score [Cohort A] - Baseline to Week 12 • CGI-I [Cohort A] - Week 12 • y-GT [Cohort A] - Week 12 • ALT [Cohort A] - Week 12 • AST [Cohort A] - Week 12 • Change in SF-36 (France, UK) [Cohort A] - Baseline to Week 12 • Change in AQoLS (France, UK) [Cohort A] - Baseline to Week 12 • Change in the number of HDDs (days/month) [Cohort B] - Baseline to Month 3 • Change in TAC [Cohort B] - Baseline to Month | — |
Countries
Germany, Spain, United Kingdom
Contacts
Public ContactLundbeckClinicalTrials@lundbeck.com
H. Lundbeck A/S
Outcome results
None listed