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

Primary Purpose

Alcohol Dependence

Status
Terminated
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Selincro® 18 mg with continuous psychosocial support: Cohort A
Initial psychosocial support: Cohort B
Sponsored by
H. Lundbeck A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Dependence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • FR010
  • FR001
  • FR005
  • FR009
  • FR012
  • FR002
  • FR008
  • FR007
  • FR011
  • FR003
  • FR006
  • FR004
  • DE002
  • DE005
  • DE006
  • DE003
  • DE004
  • DE011
  • DE009
  • DE010
  • DE001
  • DE007
  • DE008
  • ES001
  • ES010
  • ES003
  • ES004
  • ES008
  • ES007
  • ES006
  • ES009
  • ES011
  • ES002
  • ES013
  • ES012
  • ES005
  • GB011
  • GB008
  • GB009
  • GB004
  • GB005
  • GB001
  • GB002
  • GB003
  • GB006
  • GB007
  • GB010
  • GB106

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Selincro® 18 mg with continuous psychosocial support: Cohort A

Initial psychosocial support: Cohort B

Arm Description

Selincro® as-needed; tablets, orally, 12-week Treatment Period in conjunction with continuous psychosocial support

Initial psychosocial support followed by usual care practice, 12-week Observational Period

Outcomes

Primary Outcome Measures

Change in the number of Heavy Drinking Days (HDDs) (days/month)
Cohort A

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
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

Full Information

First Posted
July 17, 2014
Last Updated
February 27, 2017
Sponsor
H. Lundbeck A/S
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1. Study Identification

Unique Protocol Identification Number
NCT02195817
Brief Title
Study of 18 mg Selincro® As-needed Use, in the Treatment of Patients With Alcohol Dependence in Primary Care
Official Title
Interventional, Open-label Study of 18 mg Selincro® As-needed Use, in the Treatment of Patients With Alcohol Dependence in Primary Care
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated due to enrolment challenges
Study Start Date
August 2014 (Actual)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lundbeck A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Dependence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
378 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Selincro® 18 mg with continuous psychosocial support: Cohort A
Arm Type
Other
Arm Description
Selincro® as-needed; tablets, orally, 12-week Treatment Period in conjunction with continuous psychosocial support
Arm Title
Initial psychosocial support: Cohort B
Arm Type
Other
Arm Description
Initial psychosocial support followed by usual care practice, 12-week Observational Period
Intervention Type
Drug
Intervention Name(s)
Selincro® 18 mg with continuous psychosocial support: Cohort A
Other Intervention Name(s)
nalmefene
Intervention Type
Other
Intervention Name(s)
Initial psychosocial support: Cohort B
Primary Outcome Measure Information:
Title
Change in the number of Heavy Drinking Days (HDDs) (days/month)
Description
Cohort A
Time Frame
Baseline to Month 3
Secondary Outcome Measure Information:
Title
Change in Total Alcohol Consumption (TAC) (g/day)
Description
Cohort A
Time Frame
Baseline to Month 3
Title
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
Description
Cohort A
Time Frame
Baseline to Month 3
Title
RLDRL response; defined as a downward shift in DRL to low DRL or below
Description
Cohort A
Time Frame
Baseline to Month 3
Title
Response defined as ≥70% reduction in TAC
Description
Cohort A
Time Frame
Baseline to Month 3
Title
Response defined as 0 to 4 HDDs (days/month)
Description
Cohort A
Time Frame
Month 3
Title
Change in Clinical Global Impression - Severity of Illness (CGI-S) score
Description
Cohort A
Time Frame
Baseline to Week 12
Title
Clinical Global Impression - Global Improvement (CGI-I)
Description
Cohort A
Time Frame
Week 12
Title
y-glutamyl transferase (y-GT)
Description
Cohort A
Time Frame
Week 12
Title
Alanine aminotransferase (ALT)
Description
Cohort A
Time Frame
Week 12
Title
Aspartate aminotransferase (AST)
Description
Cohort A
Time Frame
Week 12
Title
Change in 36-item Short-form Health Survey version 2 (SF-36) (only for patients in France and the United Kingdom)
Description
Cohort A
Time Frame
Baseline to Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Email contact via H. Lundbeck A/S
Organizational Affiliation
LundbeckClinicalTrials@lundbeck.com
Official's Role
Study Director
Facility Information:
Facility Name
FR010
City
Becon-les-Granits
Country
France
Facility Name
FR001
City
Bordeaux
Country
France
Facility Name
FR005
City
Bordeaux
Country
France
Facility Name
FR009
City
Cestas
Country
France
Facility Name
FR012
City
Chauny
Country
France
Facility Name
FR002
City
Coulounieix-Chamiers
Country
France
Facility Name
FR008
City
La Teste De Buch
Country
France
Facility Name
FR007
City
Mont de Marsan
Country
France
Facility Name
FR011
City
Narbonne
Country
France
Facility Name
FR003
City
Targon
Country
France
Facility Name
FR006
City
Tonneins
Country
France
Facility Name
FR004
City
Vieux Boucau
Country
France
Facility Name
DE002
City
Berlin
Country
Germany
Facility Name
DE005
City
Berlin
Country
Germany
Facility Name
DE006
City
Essen
Country
Germany
Facility Name
DE003
City
Jahnsdorf
Country
Germany
Facility Name
DE004
City
Jahnsdorf
Country
Germany
Facility Name
DE011
City
Mannheim
Country
Germany
Facility Name
DE009
City
Nurnberg
Country
Germany
Facility Name
DE010
City
Offenbach
Country
Germany
Facility Name
DE001
City
Wallerfing
Country
Germany
Facility Name
DE007
City
Weilburg
Country
Germany
Facility Name
DE008
City
Weinheim
Country
Germany
Facility Name
ES001
City
Badalona
Country
Spain
Facility Name
ES010
City
Badalona
Country
Spain
Facility Name
ES003
City
Barcelona
Country
Spain
Facility Name
ES004
City
Barcelona
Country
Spain
Facility Name
ES008
City
Canet de Mar
Country
Spain
Facility Name
ES007
City
El Prat de Llobregat
Country
Spain
Facility Name
ES006
City
Hospitalet del Llobregat
Country
Spain
Facility Name
ES009
City
Hospitalet del Llobregat
Country
Spain
Facility Name
ES011
City
Hospitalet del Llobregat
Country
Spain
Facility Name
ES002
City
Mataro
Country
Spain
Facility Name
ES013
City
Matar
Country
Spain
Facility Name
ES012
City
Sabadell
Country
Spain
Facility Name
ES005
City
Tarragona
Country
Spain
Facility Name
GB011
City
Ballymena
Country
United Kingdom
Facility Name
GB008
City
Belfast
Country
United Kingdom
Facility Name
GB009
City
Belfast
Country
United Kingdom
Facility Name
GB004
City
Cardiff
Country
United Kingdom
Facility Name
GB005
City
Cardiff
Country
United Kingdom
Facility Name
GB001
City
Coatbridge
Country
United Kingdom
Facility Name
GB002
City
Glasgow
Country
United Kingdom
Facility Name
GB003
City
Lanarkshire
Country
United Kingdom
Facility Name
GB006
City
Swansea
Country
United Kingdom
Facility Name
GB007
City
Swansea
Country
United Kingdom
Facility Name
GB010
City
Swansea
Country
United Kingdom
Facility Name
GB106
City
Swansea
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
https://www.clinicaltrialsregister.eu/ctr-search/trial/2013-004688-30/results
Description
EMA EudraCT Results: 2013-004688-30

Learn more about this trial

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

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