The effectiveness of the original anticonvulsant Galodif® — a GABAA receptor modulator for alcohol withdrawal syndrome

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Abstract

BACKGROUND: The development of new drugs to improve the effectiveness of treatment and rehabilitation programs for patients suffering from addiction diseases, which are non-addictive and have a stimulating effect on detoxification processes in the body, can increase the effectiveness of therapy and reduce the cost of treatment. A deficiency of GABAergic inhibition in brain structures plays a leading role in the occurrence of paroxysmalness. The innovative anticonvulsant Galodif® (1-[(3-chlorophenyl)(phenyl)methyl]urea), a GABAA receptor modulator, has low toxicity and hepatoprotective properties, which allows it to be recommended for use in the treatment of patients with alcohol dependence.

AIM: The aim of this study is to evaluation of the effectiveness of the use of the anticonvulsant drug galodif1 in complex therapy in patients with alcohol dependence with compulsive and paroxysmal disorders with pathological craving for alcohol when withdrawing of alcohol.

MATERIALS AND METHODS: A limited open-type clinical study of the therapeutic effectiveness of the innovative anticonvulsant galodif1 included 128 male patients (average age 38.3 ± 8.9 years) with a diagnosis of “Mental and behavioral disorders as a result of alcohol consumption, dependence syndrome” (F10.232) and “Mental and behavioral disorders as a result of alcohol consumption, withdrawal states” (F10.302). 68 patients received Galodif® 300 mg per day as an anticonvulsant for 21 days. 60 patients made up the comparison group, receiving carbamazepine at a dose of 400 mg per day.

RESULTS: The use of the anticonvulsant Galodif® in complex therapy of patients revealed: normothymoleptic activity of the drug; when assessing depression on the Hamilton Depression Rating Scale (HDRS), the average total score decreased from 28.3 ± 1.3 to 5.7 ± 1.9, and a reduction in unmotivated fear and anxiety was noted; vegetative stabilizing effect with a sympathicolytic component with normalization of heart rate; reduction of headaches; weakening or disappearance of pathological desire during withdrawal syndrome in 88% of cases, in the post-withdrawal state — in 57% of cases; taking the drug did not cause any unwanted side effects.

CONCLUSIONS: The use of the anticonvulsant Galodif®, which modulates GABAA receptors, has low toxicity and detoxification properties and does not cause side effects, has been proposed as one of the modern pharmacotherapeutic approaches in the treatment of patients with alcohol dependence.

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About the authors

Tamara V. Shushpanova

Tomsk National Research Medical Center of the Russian Academy of Sciences

Author for correspondence.
Email: shush59@mail.ru
ORCID iD: 0000-0002-9455-0358
SPIN-code: 9158-9235
Scopus Author ID: 6506299310
ResearcherId: J-2817-2017

MD, Cand. Sci. (Medicine), Mental Health Research Institute

Russian Federation, Tomsk

Anna I. Mandel

Tomsk National Research Medical Center of the Russian Academy of Sciences

Email: anna-mandel@mail.ru
ORCID iD: 0000-0002-6020-6604
SPIN-code: 7428-9823
Scopus Author ID: 57197930313
ResearcherId: J-1692-2017

MD, Dr. Sci. (Medicine), Professor, Mental Health Research Institute

Russian Federation, Tomsk

Nikolay A. Bokhan

Tomsk National Research Medical Center of the Russian Academy of Sciences; Siberian State Medical University

Email: mental@tnimc.ru
ORCID iD: 0000-0002-1052-855X
SPIN-code: 2419-1263
Scopus Author ID: 6506895310
ResearcherId: P-1720-2014

MD, Dr. Sci. (Medicine), Professor, Academician of Russian Academy of Sciences, Mental Health Research Institute

Russian Federation, Tomsk; Tomsk

Evgeny D. Schastnyy

Tomsk National Research Medical Center of the Russian Academy of Sciences

Email: evgeny.schastnyy@gmail.com
ORCID iD: 0000-0003-2148-297X
SPIN-code: 6482-2439
Scopus Author ID: 57207962881
ResearcherId: S-3674-2016

MD, Dr. Sci. (Medicine), Professor, Mental Health Research Institute

Russian Federation, Tomsk

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