Аннотация:
Introduction. According to experts of the World Health Organization, alcohol dependence is considered one of the most common and burdensome mental disorders and is a priority public health problem in most countries of the world community. According to statistics in 2021, the total number of people with alcohol dependence in Russia is 4.96 million people – 3.4% of the total population. Mental and behavioral disorders caused by alcohol consumption in the Russian Federation are included in the list of socially significant diseases. Inclusion in this list is determined by the danger to others, the severity of the damage caused to society, the role of the disease in primary disability and mortality, and a decrease in life expectancy. High social significance determines the priority of approaches to treatment issues, dictates the need to develop new drugs and improve methodological approaches to assessing their effectiveness and safety.
Aim: to optimize methodological approaches for conducting clinical trials of drugs intended for the treatment of alcohol dependence.
Methods. The study uses an information-analytical method of selecting relevant information by keywords in available scientific databases in accordance with the research objectives: RSCI, Scopus, Microsoft Academic, MedLine, PubMed, Wiley (Collection of journals (2016–2021)).
Results. The article presents current epidemiological data on morbidity, gives a comprehensive overview of modern ideas about pathogenesis, classification, diagnosis and treatment. The features of the expert evaluation of psychotropic drugs and the organization of clinical trials in patients with alcohol dependence are considered in detail. Various psychometric scales specific to clinical narcology are recommended. A number of features of the protocol are noted, which are important to consider when compiling the design of the study. Methodological aspects of studies of new drugs in risk groups with increased alcohol consumption are given. The information presented in the article can help in the development of a design and strategy for conducting clinical trials of new drugs for the treatment of alcohol dependence.
Ключевые слова:
alcohol dependence, diagnostic scales; assessment scales of severity of withdrawal disorders, prevention of relapse of alcohol dependence, psychotropic drugs, methodology of clinical trials.