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

February 27, 2017 updated by: H. Lundbeck A/S

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

378

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Becon-les-Granits, France
        • FR010
      • Bordeaux, France
        • FR001
      • Bordeaux, France
        • FR005
      • Cestas, France
        • FR009
      • Chauny, France
        • FR012
      • Coulounieix-Chamiers, France
        • FR002
      • La Teste De Buch, France
        • FR008
      • Mont de Marsan, France
        • FR007
      • Narbonne, France
        • FR011
      • Targon, France
        • FR003
      • Tonneins, France
        • FR006
      • Vieux Boucau, France
        • FR004
  • Germany
      • Berlin, Germany
        • DE002
      • Berlin, Germany
        • DE005
      • Essen, Germany
        • DE006
      • Jahnsdorf, Germany
        • DE003
      • Jahnsdorf, Germany
        • DE004
      • Mannheim, Germany
        • DE011
      • Nurnberg, Germany
        • DE009
      • Offenbach, Germany
        • DE010
      • Wallerfing, Germany
        • DE001
      • Weilburg, Germany
        • DE007
      • Weinheim, Germany
        • DE008
  • Spain
      • Badalona, Spain
        • ES001
      • Badalona, Spain
        • ES010
      • Barcelona, Spain
        • ES003
      • Barcelona, Spain
        • ES004
      • Canet de Mar, Spain
        • ES008
      • El Prat de Llobregat, Spain
        • ES007
      • Hospitalet del Llobregat, Spain
        • ES006
      • Hospitalet del Llobregat, Spain
        • ES009
      • Hospitalet del Llobregat, Spain
        • ES011
      • Matar, Spain
        • ES013
      • Mataro, Spain
        • ES002
      • Sabadell, Spain
        • ES012
      • Tarragona, Spain
        • ES005
  • United Kingdom
      • Ballymena, United Kingdom
        • GB011
      • Belfast, United Kingdom
        • GB008
      • Belfast, United Kingdom
        • GB009
      • Cardiff, United Kingdom
        • GB004
      • Cardiff, United Kingdom
        • GB005
      • Coatbridge, United Kingdom
        • GB001
      • Glasgow, United Kingdom
        • GB002
      • Lanarkshire, United Kingdom
        • GB003
      • Swansea, United Kingdom
        • GB006
      • Swansea, United Kingdom
        • GB007
      • Swansea, United Kingdom
        • GB010
      • Swansea, United Kingdom
        • GB106

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

To ensure the study is broadly representative of primary care clinical practice, minimal inclusion and exclusion criteria are imposed with the main exclusion criteria relating to contraindications to the prescription of Selincro® and reflecting the indication wording in the SmPC.

Inclusion Criteria:

  • The patient has alcohol dependence diagnosed according to ICD-10.
  • The patient has had a high DRL 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.

Exclusion Criteria:

  • The patient has one or more contraindications to the prescription of Selincro®:

    • hypersensitivity to the active substance or to any of the excipients
    • taking opioid analgesics
    • current or recent opioid addiction
    • acute symptoms of opioid withdrawal
    • recent use of opioids suspected
    • severe hepatic impairment (Child-Pugh classification)
    • severe renal impairment (eGFR <30 ml/min per 1.73 m2)
    • a recent history of acute alcohol withdrawal syndrome (including hallucinations, seizures, or delirium tremens)
  • The patient has had <6 HDDs (defined by the European Medicines Agency as a day with an alcohol consumption >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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Selincro® 18 mg with continuous psychosocial support: Cohort A
Selincro® as-needed; tablets, orally, 12-week Treatment Period in conjunction with continuous psychosocial support
Drug: Selincro® 18 mg with continuous psychosocial support: Cohort A
Other Names:
  • nalmefene
Other: Initial psychosocial support: Cohort B
Initial psychosocial support followed by usual care practice, 12-week Observational Period
Other: Initial psychosocial support: Cohort B

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

H. Lundbeck A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2014

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

July 17, 2014

First Submitted That Met QC Criteria

July 18, 2014

First Posted (Estimate)

July 21, 2014

Study Record Updates

Last Update Posted (Actual)

February 28, 2017

Last Update Submitted That Met QC Criteria

February 27, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15892A
  • 2013-004688-30 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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