almefene Efficacy Study I: Randomised, double-blind, placebo-controlled, parallel-group, efficacy study of 20 mg nalmefene, as needed use, in patients with alcohol dependence

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 600

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 < 0.02 % at the screening visit
4. The patient has a diagnosis of Alcohol Dependence (diagnostic code 303.90) according to DSM-IV-TR
5. The patient is a man or woman, aged 18 years or over
6. The patient provides a stable address and telephone number
7. The patient provides an identified locator person that can be contacted during the study in the event of loss of contact
8. The patient, if female must:
- agree not to try to become pregnant during the study, and
- use adequate contraception (adequate contraception is defined as oral/systemic contraception, intrauterine device, diaphragm in combination with spermicide, or condom for male partner in combination with spermicide), or
- have had her last natural menstruation at least 24 months prior to baseline, or
- have been surgically sterilised prior to baseline, or
- have had a hysterectomy prior to baseline, or
- not be sexually active with men

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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 cognitive impairment which judged by the investigator is likely to interfere with the patient’s understanding of the study and its procedures
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, topiramate, naltrexone or carbimide, 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 (4 weeks prior to the screening visit) participated in a treatment or support programme for al

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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