Status:
TERMINATED
Study of 18 mg Selincro® As-needed Use, in the Treatment of Patients With Alcohol Dependence in Primary Care
Lead Sponsor:
H. Lundbeck A/S
Conditions:
Alcohol Dependence
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 con...
Eligibility Criteria
Inclusion
- 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.
- 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
- 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.
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2016
Estimated Enrollment :
378 Patients enrolled
Trial Details
Trial ID
NCT02195817
Start Date
August 1 2014
End Date
February 1 2016
Last Update
February 28 2017
Active Locations (48)
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1
FR010
Bécon-les-Granits, France
2
FR001
Bordeaux, France
3
FR005
Bordeaux, France
4
FR009
Cestas, France