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

NCT02195817 | Terminated Phase 4

• 2 other identifiers: 15892A2013-004688-30
• Study Type: interventional
• Target: 378
• Locations: 4 countries
• Sites: 48

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

Conditions

Alcohol Dependence

Outcome Measures

Primary Outcomes (1)

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

  Cohort A

  Baseline to Month 3

Secondary Outcomes (11)

• Change in Total Alcohol Consumption (TAC) (g/day)

  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

  Baseline to Month 3

• RLDRL response; defined as a downward shift in DRL to low DRL or below

  Baseline to Month 3

• Response defined as ≥70% reduction in TAC

  Baseline to Month 3

• Response defined as 0 to 4 HDDs (days/month)

  Month 3

Study Arms (2)

Selincro® 18 mg with continuous psychosocial support: Cohort A

OTHER

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

Initial psychosocial support: Cohort B

OTHER

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

Other: Initial psychosocial support: Cohort B

Interventions

Selincro® 18 mg with continuous psychosocial support: Cohort A DRUG

Also known as: nalmefene

Selincro® 18 mg with continuous psychosocial support: Cohort A

Initial psychosocial support: Cohort B OTHER

Initial psychosocial support: Cohort B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• H. Lundbeck A/S: lead

Study Sites (48)

FR010

Bécon-les-Granits, France

Location

FR001

Bordeaux, France

Location

FR005

Bordeaux, France

Location

FR009

Cestas, France

Location

FR012

Chauny, France

Location

FR002

Coulounieix-Chamiers, France

Location

FR008

La Teste-de-Buch, France

Location

FR007

Mont-de-Marsan, France

Location

FR011

Narbonne, France

Location

FR003

Targon, France

Location

FR006

Tonneins, France

Location

FR004

Vieux-Boucau-les-Bains, France

Location

DE002

Berlin, Germany

Location

DE005

Berlin, Germany

Location

DE006

Essen, Germany

Location

DE003

Jahnsdorf, Germany

Location

DE004

Jahnsdorf, Germany

Location

DE011

Mannheim, Germany

Location

DE009

Nuremberg, Germany

Location

DE010

Offenbach, Germany

Location

DE001

Wallerfing, Germany

Location

DE007

Weilburg, Germany

Location

DE008

Weinheim, Germany

Location

ES001

Badalona, Spain

Location

ES010

Badalona, Spain

Location

ES003

Barcelona, Spain

Location

ES004

Barcelona, Spain

Location

ES008

Canet de Mar, Spain

Location

ES007

el Prat de Llobregat, Spain

Location

ES006

Hospitalet Del Llobregat, Spain

Location

ES009

Hospitalet Del Llobregat, Spain

Location

ES011

Hospitalet Del Llobregat, Spain

Location

ES002

Mataró, Spain

Location

ES013

Matar, Spain

Location

ES012

Sabadell, Spain

Location

ES005

Tarragona, Spain

Location

GB011

Ballymena, United Kingdom

Location

GB008

Belfast, United Kingdom

Location

GB009

Belfast, United Kingdom

Location

GB004

Cardiff, United Kingdom

Location

GB005

Cardiff, United Kingdom

Location

GB001

Coatbridge, United Kingdom

Location

GB002

Glasgow, United Kingdom

Location

GB003

Lanarkshire, United Kingdom

Location

GB006

Swansea, United Kingdom

Location

GB007

Swansea, United Kingdom

Location

GB010

Swansea, United Kingdom

Location

GB106

Swansea, United Kingdom

Location

Related Links

• EMA EudraCT Results: 2013-004688-30

MeSH Terms

Conditions

Alcoholism

Interventions

nalmefene

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Email contact via H. Lundbeck A/S

  LundbeckClinicalTrials@lundbeck.com

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2014
• First Posted: July 21, 2014
• Study Start: August 1, 2014
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: February 28, 2017

Record last verified: 2017-02

Locations

GB (12); ES (13); FR (12); DE (11)