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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02195817

Enrollment

378

Registered

2014-07-21

Start date

2014-08-31

Completion date

2016-02-29

Last updated

2017-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Dependence

Brief 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).

Interventions

DRUGSelincro® 18 mg with continuous psychosocial support: Cohort A

OTHERInitial psychosocial support: Cohort B

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

To ensure the study is broadly representative of primary care clinical practice, minimal inclusion and

Exclusion criteria

are imposed with the main

Design outcomes

Primary

Measure	Time frame	Description
Change in the number of Heavy Drinking Days (HDDs) (days/month)	Baseline to Month 3	Cohort A

Secondary

Measure	Time frame	Description
Change in Clinical Global Impression - Severity of Illness (CGI-S) score	Baseline to Week 12	Cohort A
Change in Total Alcohol Consumption (TAC) (g/day)	Baseline to Month 3	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	Baseline to Month 3	Cohort A
RLDRL response; defined as a downward shift in DRL to low DRL or below	Baseline to Month 3	Cohort A
Response defined as ≥70% reduction in TAC	Baseline to Month 3	Cohort A
Response defined as 0 to 4 HDDs (days/month)	Month 3	Cohort A
y-glutamyl transferase (y-GT)	Week 12	Cohort A
Alanine aminotransferase (ALT)	Week 12	Cohort A
Aspartate aminotransferase (AST)	Week 12	Cohort A
Change in 36-item Short-form Health Survey version 2 (SF-36) (only for patients in France and the United Kingdom)	Baseline to Week 12	Cohort A
Clinical Global Impression - Global Improvement (CGI-I)	Week 12	Cohort A

Countries

France, Germany, Spain, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026