Randomised,Double-blind,placebo trial, Nalmefene in Alcohol Dependence

• Research type

  Research Study

• Full title

  A 52-week, randomised, double-blind, placebo-controlled, parallel-group, safety and tolerability study of nalmefene, as needed use, in patients with alcohol dependence

• IRAS ID

  8792

• Contact name

  Jonathan Chick

• Sponsor organisation

  H. Lundbeck A/S

• Eudract number

  2007-002315-92

• Clinicaltrials.gov Identifier

  00811941

• Research summary

  The purpose of this study is to evaluate the long term safety and tolerability of as needed use of 20 mg nalmefene versus placebo over a period of 52 weeks in patients with alcohol dependence. On the basis of a previous phase 3 study with a flexible dose schedule (10-40 mg as needed), it appears that the 20mg dose of nalmefene taken prior to the anticipated time of drinking is effective and well tolerated. After 1-2 weeks of screening, patients meeting all inclusion criteria and none of the exclusion criteria will be randomized 3:1 to one of the two treatment arms. Patients will be instructed to take one tablet orally on days when the patient perceives a risk of drinking alcohol, preferably 1-2 hours prior to anticipated time of drinking. If the patient has started drinking alcohol without taking a tablet, the patient should take one tablet as soon as possible. Tablets can be used up to once daily if needed.

• REC name

  West of Scotland REC 1

• REC reference

  08/S0703/148

• Date of REC Opinion

  6 Mar 2009

• REC opinion

  Further Information Favourable Opinion