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

Alcohol Dependence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02195817
• Other study ID #: 15892A
• Secondary ID: 2013-004688-30
• Status: Terminated
• Phase: Phase 4
• First received: July 17, 2014
• Last updated: February 27, 2017
• Start date: August 2014
• Est. completion date: February 2016

Study information

• Verified date: February 2017
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 378
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol Dependence
• Alcoholism

Intervention

Drug:
• Selincro® 18 mg with continuous psychosocial support: Cohort A

Other:
• Initial psychosocial support: Cohort B

Locations

Country	Name	City	State
France	FR010	Becon-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
Germany	DE002	Berlin
Germany	DE005	Berlin
Germany	DE006	Essen
Germany	DE003	Jahnsdorf
Germany	DE004	Jahnsdorf
Germany	DE011	Mannheim
Germany	DE009	Nurnberg
Germany	DE010	Offenbach
Germany	DE001	Wallerfing
Germany	DE007	Weilburg
Germany	DE008	Weinheim
Spain	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	ES013	Matar
Spain	ES002	Mataro
Spain	ES012	Sabadell
Spain	ES005	Tarragona
United Kingdom	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

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Countries where clinical trial is conducted

France,  Germany,  Spain,  United Kingdom, 

Outcome

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

External Links

•   EMA EudraCT Results: 2013-004688-30