This is a double-blind placebo controlled randomized parallel-group multi-centre clinical study to access efficiency and safety conducted in adaptive design with two periods in patients with alcohol abuse.
The main study objective is to demonstrate therapeutic efficacy of the investigational product, which is nasal drops, in patients suffering from alcohol disorder, according to one of the two criteria: either stabilization of remission on the 16th week of therapy or decrease in consumption of alcohol on the 16th week of therapy, comparing to the same index before the investigational drug administration.
Among the additional objectives of the current study, the following can be marked out:
Previously conducted pre-clinical studies of the investigational nasal drops showed that its administration in animals (rats) who had a free choice between alcohol solution and water had led to prolonged decline in consumption of alcohol. Moreover, the distinctive feature of the investigational drug is its delayed and growing effect after the completion of administration.
The safety of these nasal drops has been previously investigated in the framework of the phase I study in 12 healthy volunteers.
Alcohol abuse is a major public health problem in Russia, which has one of the highest rates of alcohol consumption in the world. This is the major reason why many European and American pharmaceutical and biotechnology companies place trials in alcoholic patients and patients with alcohol abuse-related diseases in this region. The Sponsor of the current study is a Russian biotechnology company, and it is planned to screen 137 patients, 115 of which will be randomized, in the current study.