A 52-week, randomised, double-blind, placebo-controlled, parallel-group, safety, tolerability and efficacy study of nalmefene, as needed use, in patients with alcohol dependence
- Conditions
- Alcohol dependenceMedDRA version: 9.1Level: LLTClassification code 10001594Term: Alcohol dependence syndrome
- Registration Number
- EUCTR2007-002315-92-LT
- Lead Sponsor
- H. Lundbeck A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 668
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 a 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
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 of alcohol consumption with 60 g or more for males and 40 g or more for females.
2. The patient has more than 14 consecutive abstinent days in the 4 weeks preceding the screening visit.
3. The patient has a CIWA-Ar score of 10 or more.
4. The patient has a severe psychiatric disorder (such as psychosis, schizophrenia, severe depression, eating disorders, bipolar disorder), antisocial personality disorder or other disorders for which the treatment takes priority over treatment of the drinking problem, or is likely to interfere with study treatment or impairs treatment compliance.
5. 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).
6. The patient has a history of delirium tremens or alcohol withdrawal seizures.
7. The patient has a cognitive impairment which judged by the investigator is likely to
interfere with the patient’s understanding of the study and its procedures.
8. The patient reports or urine drug screen reveals current use of substances of abuse other than alcohol, cannabis, nicotine or benzodiazepines.
9. The patient has seizure disorder, mental retardation, or encephalopathy in the medical history.
10. 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.
11. The patient has clinically significant abnormal vital signs.
12. 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.
13. The patient has clinically significant abnormal findings in ECG.
14. The patient has a history of severe drug allergy or hypersensitivity.
15. The patient reports current or recent (within 3 months preceding screening) treatment with disulfiram, acamprosate, topiramate, naltrexone or carbimide, or with any opioid antagonists.
16. The patient reports current or recent (within 1 week preceding screening) treatment with opioid agonists or partial agonists.
17. The patient used/uses disallowed recent or concomitant medication (specified in Appendix II, Recent and Concomitant Medication) or it is anticipated that the patient will require treatment with at least one of the disallowed concomitant medications during the study.
18. 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.
19. The patient is currently participating or has recently (4 weeks prior to 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.
20. The patient has been treated with any investigational medicinal product within 30 days or 5 half lives (whichever is longer) prior to screening.
21. The patient is pregnant or breast-feeding.
22. The patient, in the opinion of the investigator, is unlikely to comply with the clinical study protocol or is unsuitable for any reason.
23. The patient is a member of the site pe
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