Clinical trial NCT02195817: 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
Overall status: TERMINATED
Phase: PHASE4
Conditions: Alcohol Dependence
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2014-07-21
Enrollment: 378
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Change in the number of Heavy Drinking Days (HDDs) (days/month)
timeFrame: Baseline to Month 3
Secondary outcomes:
measure: Change in Total Alcohol Consumption (TAC) (g/day)
timeFrame: Baseline to Month 3
measure: 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
timeFrame: Baseline to Month 3
measure: RLDRL response; defined as a downward shift in DRL to low DRL or below
timeFrame: Baseline to Month 3
measure: Response defined as ≥70% reduction in TAC
timeFrame: Baseline to Month 3
measure: Response defined as 0 to 4 HDDs (days/month)
timeFrame: Month 3
measure: Change in Clinical Global Impression - Severity of Illness (CGI-S) score
timeFrame: Baseline to Week 12
measure: Clinical Global Impression - Global Improvement (CGI-I)
timeFrame: Week 12
measure: y-glutamyl transferase (y-GT)
timeFrame: Week 12
measure: Alanine aminotransferase (ALT)
timeFrame: Week 12
measure: Aspartate aminotransferase (AST)
timeFrame: Week 12
measure: Change in 36-item Short-form Health Survey version 2 (SF-36) (only for patients in France and the United Kingdom)
timeFrame: Baseline to Week 12
Other outcomes:
Locations:
city: Becon-les-Granits
country: France
facility: FR010
city: Bordeaux
country: France
facility: FR001
city: Bordeaux
country: France
facility: FR005
city: Cestas
country: France
facility: FR009
city: Chauny
country: France
facility: FR012
city: Coulounieix-Chamiers
country: France
facility: FR002
city: La Teste De Buch
country: France
facility: FR008
city: Mont de Marsan
country: France
facility: FR007
city: Narbonne
country: France
facility: FR011
city: Targon
country: France
facility: FR003
city: Tonneins
country: France
facility: FR006
city: Vieux Boucau
country: France
facility: FR004
city: Berlin
country: Germany
facility: DE002
city: Berlin
country: Germany
facility: DE005
city: Essen
country: Germany
facility: DE006
city: Jahnsdorf
country: Germany
facility: DE003
city: Jahnsdorf
country: Germany
facility: DE004
city: Mannheim
country: Germany
facility: DE011
city: Nurnberg
country: Germany
facility: DE009
city: Offenbach
country: Germany
facility: DE010
city: Wallerfing
country: Germany
facility: DE001
city: Weilburg
country: Germany
facility: DE007
city: Weinheim
country: Germany
facility: DE008
city: Badalona
country: Spain
facility: ES001
city: Badalona
country: Spain
facility: ES010
city: Barcelona
country: Spain
facility: ES003
city: Barcelona
country: Spain
facility: ES004
city: Canet de Mar
country: Spain
facility: ES008
city: El Prat de Llobregat
country: Spain
facility: ES007
city: Hospitalet del Llobregat
country: Spain
facility: ES006
city: Hospitalet del Llobregat
country: Spain
facility: ES009
city: Hospitalet del Llobregat
country: Spain
facility: ES011
city: Mataro
country: Spain
facility: ES002
city: Matar
country: Spain
facility: ES013
city: Sabadell
country: Spain
facility: ES012
city: Tarragona
country: Spain
facility: ES005
city: Ballymena
country: United Kingdom
facility: GB011
city: Belfast
country: United Kingdom
facility: GB008
city: Belfast
country: United Kingdom
facility: GB009
city: Cardiff
country: United Kingdom
facility: GB004
city: Cardiff
country: United Kingdom
facility: GB005
city: Coatbridge
country: United Kingdom
facility: GB001
city: Glasgow
country: United Kingdom
facility: GB002
city: Lanarkshire
country: United Kingdom
facility: GB003
city: Swansea
country: United Kingdom
facility: GB006
city: Swansea
country: United Kingdom
facility: GB007
city: Swansea
country: United Kingdom
facility: GB010
city: Swansea
country: United Kingdom
facility: GB106
Study officials:
affiliation: LundbeckClinicalTrials@lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References: