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

Lundbeck

Status and phase

Terminated

Phase 4

Conditions

Alcohol Dependence

Treatments

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

Other: Initial psychosocial support: Cohort B

Study type

Interventional

Funder types

Industry

Identifiers

NCT02195817

2013-004688-30 (EudraCT Number)

15892A

Details and patient eligibility

About

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

Full 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).

Enrollment

378 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.