Study of 18 mg Selincro® As-needed Use, in the Treatment of Patients With Alcohol Dependence in Primary Care
NCT ID: NCT02195817
Last Updated: 2017-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE4
378 participants
INTERVENTIONAL
2014-08-31
2016-02-29
Brief Summary
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Detailed Description
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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
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Selincro® 18 mg with continuous psychosocial support: Cohort A
Selincro® as-needed; tablets, orally, 12-week Treatment Period in conjunction with continuous psychosocial support
Selincro® 18 mg with continuous psychosocial support: Cohort A
Initial psychosocial support: Cohort B
Initial psychosocial support followed by usual care practice, 12-week Observational Period
Initial psychosocial support: Cohort B
Interventions
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Selincro® 18 mg with continuous psychosocial support: Cohort A
Initial psychosocial support: Cohort B
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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H. Lundbeck A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Locations
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FR010
Bécon-les-Granits, , France
FR001
Bordeaux, , France
FR005
Bordeaux, , France
FR009
Cestas, , France
FR012
Chauny, , France
FR002
Coulounieix-Chamiers, , France
FR008
La Teste-de-Buch, , France
FR007
Mont-de-Marsan, , France
FR011
Narbonne, , France
FR003
Targon, , France
FR006
Tonneins, , France
FR004
Vieux-Boucau-les-Bains, , France
DE002
Berlin, , Germany
DE005
Berlin, , Germany
DE006
Essen, , Germany
DE003
Jahnsdorf, , Germany
DE004
Jahnsdorf, , Germany
DE011
Mannheim, , Germany
DE009
Nuremberg, , Germany
DE010
Offenbach, , Germany
DE001
Wallerfing, , Germany
DE007
Weilburg, , Germany
DE008
Weinheim, , Germany
ES001
Badalona, , Spain
ES010
Badalona, , Spain
ES003
Barcelona, , Spain
ES004
Barcelona, , Spain
ES008
Canet de Mar, , Spain
ES007
el Prat de Llobregat, , Spain
ES006
Hospitalet Del Llobregat, , Spain
ES009
Hospitalet Del Llobregat, , Spain
ES011
Hospitalet Del Llobregat, , Spain
ES002
Mataró, , Spain
ES013
Matar, , Spain
ES012
Sabadell, , Spain
ES005
Tarragona, , Spain
GB011
Ballymena, , United Kingdom
GB008
Belfast, , United Kingdom
GB009
Belfast, , United Kingdom
GB004
Cardiff, , United Kingdom
GB005
Cardiff, , United Kingdom
GB001
Coatbridge, , United Kingdom
GB002
Glasgow, , United Kingdom
GB003
Lanarkshire, , United Kingdom
GB006
Swansea, , United Kingdom
GB007
Swansea, , United Kingdom
GB010
Swansea, , United Kingdom
GB106
Swansea, , United Kingdom
Countries
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Related Links
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EMA EudraCT Results: 2013-004688-30
Other Identifiers
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2013-004688-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
15892A
Identifier Type: -
Identifier Source: org_study_id
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