NCT02195817

Study of 18 mg Selincro® As-needed Use, in the Treatment of Patients With Alcohol Dependence in Primary Care

Interventional, Open-label Study of 18 mg Selincro® As-needed Use, in the Treatment of Patients With Alcohol Dependence in Primary Care

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 378 (actual)
• Sponsor: H. Lundbeck A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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).

Conditions

• Alcohol Dependence

Interventions

Type	Name	Description
DRUG	Selincro® 18 mg with continuous psychosocial support: Cohort A
OTHER	Initial psychosocial support: Cohort B

Timeline

• Start date: 2014-08-01
• Primary completion: 2016-02-01
• Completion: 2016-02-01
• First posted: 2014-07-21
• Last updated: 2017-02-28

Locations

48 sites across 4 countries: France, Germany, Spain, United Kingdom