Study of 18 mg Selincro® As-needed Use in Alcohol Dependent Patients
Research type
Research Study
Full title
Interventional, open-label study of 18 mg Selincro® as needed use, in the treatment of patients with alcohol dependence in primary care
IRAS ID
151745
Contact name
Edmund Stewart
Contact email
Sponsor organisation
H. Lundbeck A/S
Eudract number
2013-004688-30
Duration of Study in the UK
1 years, 4 months, 0 days
Research summary
Selincro® (nalmefene) is a recently approved and registered medication and is used together with psychosocial support to reduce alcohol consumption in patients with alcohol dependence who still have a high level of alcohol consumption during the period of observation that follows an initial assessment by their doctor.
Selincro® has been tested at specialist centres throughout Europe but not in a primary care setting. This is an interventional, open-label trial planned to be conducted in a primary care setting in multiple-sites from UK, Germany, France, Italy and Spain. The study will consist of two Cohorts, A and B as described below.The main purpose of the study is to determine the reduction in alcohol consumption in patients with alcohol dependence who will be treated with Selincro® (as-needed use) in conjunction with continuous psychosocial support(Cohort A).
The secondary purpose of the study is to determine the reduction in alcohol consumption in patients with alcohol dependence who reduce their alcohol consumption on their own in the 2-week observation period after the initial assessment of their alcohol consumption by the study doctor. These patients are not eligible for Selincro® treatment and will enter the observational group after having received initial psychosocial support (Cohort B).
We propose to enroll approximately 635 patients from 55 sites in 5 countries. We expect to have 127 patients participating in each country (95 people in Cohort A and 32 patients in Cohort B).
The duration of the study will be 14 or 16 weeks for Cohort A and Cohort B, respectively.
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
14/EM/1065
Date of REC Opinion
13 Aug 2014
REC opinion
Favourable Opinion