Alcohol dependence MedDRA version: 9.1 Level: LLT Classification code 10001594 Term: Alcohol dependence syndrome
Conditions
Sponsors
H. Lundbeck A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The patient is able to read and understand the Subject Information Sheet 2. The patient has signed the Informed Consent Form 3. The patient has a BAC of =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. The patient has less than 6 heavy drinking days (HDD) in the 4 weeks preceding the screening visit. A HDD is defined as a day with alcohol consumption of 60 g or more for males and 40 g or more for females 2. The patient has an average alcohol consumption below medium risk levels in the 4 weeks preceeding the screening visit (for males, =40 grams of ethanol/day, for females =20 grams of ethanol/day) 3. The patient has more than 14 consecutive abstinent days in the 4 weeks preceding the screening visit 4. The patient has a CIWA-Ar score of 10 or more 5. The patient has a • DSM-IV Axis I disorder other than alcohol dependence or nicotine dependence evaluated by MINI, • antisocial personality disorder evaluated by MINI, • or other disorders for which the treatment takes priority over treatment of the drinking problem, or are likely to interfere with study treatment or impair treatment compliance Use of cannabis is not reason for exclusion unless fulfilling criteria for cannabis dependence. 6. The patient has risk of suicide evaluated by the suicidality module of MINI (the patient answers ‘yes’ to any of the questions C2, C3, C4, C5, or C6) 7. The patient has a history of delirium tremens or alcohol withdrawal seizures 8. The patient has a cognitive disorder as judged by the investigator 9. The patient reports or urine drug screen reveals current use of substances of abuse other than alcohol, cannabis, nicotine or benzodiazepines 10. The patient has seizure disorder, mental retardation, or encephalopathy 11. The patient has a clinically significant unstable illness, for example, hepatic or renal insufficiency, or a cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, infectious, neoplastic, or metabolic disturbance 12. The patient has clinically significant abnormal vital signs 13. The patient has S-ASAT and/or S-ALAT levels greater than 3 times of upper normal limit, or one or more laboratory values outside the normal range, based on the blood or urine samples taken at the Screening Visit, that are considered by the investigator to be clinically significant 14. The patient has a clinically significant abnormal ECG 15. The patient has a history of severe drug allergy or hypersensitivity 16. The patient reports current or recent (within 3 months preceding screening) treatment with disulfiram, acamprosate or naltrexone, topiramate, or with any opioid antagonists 17. The patient reports current or recent (within 1 week preceding screening) treatment with opioid agonists or partial agonists 18. The patient reports current or recent (within 8 weeks preceding screening) treatment with antipsychotics or antidepressants 19. The patient used/uses disallowed recent or concomitant medication (specified in Appendix II) or it is anticipated that the patient will require treatment with at least one of the disallowed concomitant medications during the study 20. The patient has a disease or takes medication that, in the opinion of the investigator, could interfere with the assessments of safety, tolerability, or efficacy 21. The patient has been treated with any investigational medicinal product within 30 days or 5 half lives (whichever is longer) prior to screening 22. The patient is currently participating or has recently (8 weeks prior to the screening visit) participated in a treatment or support programme for alcohol use disorders 23. The patient is pregnant or breast-feeding 24. The patient, in the opinion of the investi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of as needed use of 20 mg nalmefene on alcohol consumption by the monthly number of heavy drinking days and the monthly total consumption in patients with alcohol dependence during a treatment period of 24 weeks;Secondary Objective: o To evaluate the effect of as needed use of 20 mg nalmefene in patients with alcohol dependence during a treatment period of 24 weeks, on: - proportion of responders based on drinking measures - alcohol dependence symptoms and clinical status - liver function and other biological laboratory tests - pharmacoeconomic outcomes o To evaluate treatment discontinuation effects after 24-week as needed nalmefene treatment o To evaluate the safety and tolerability of as needed use of 20 mg nalmefene in patients with alcohol dependence. ;Primary end point(s): Baseline for the co-primary and secondary drinking parameters are defined as the 4 weeks preceding the screening visit. One month is defined as 4 weeks (28 days). • Co-primary variables: – Change from baseline at month 6 in the monthly number of heavy drinking days (HDD), defined as a day of alcohol consumption of 60 g or more for males and 40 g or more for females. – Change from baseline at month 6 in the total alcohol consumption, defined as mean daily alcohol consumption in grams/day over a month. | — |
Countries
Belgium, Czech Republic, France, Italy, Poland, Portugal, Spain
Outcome results
None listed