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Krupitskiĭ E.M.
Sankt-Peterburgskiĭ nauchno-issledovatel'skiĭ psikhonevrologicheskiĭ institut im. V.M. Bekhtereva
Rybakova K.V.
Sankt-Peterburgskiĭ nauchno-issledovatel'skiĭ psikhonevrologicheskiĭ institut im. V.M. Bekhtereva, Sankt-Peterburg
Skurat E.P.
St. Petersburg V.M. Bekhterev Research Psychoneurological Institute, St. Peterburg, Russia
Semenova N.V.
FGBU "Nauchnyĭ tsentr problem zdorov'ia sem'i i reproduktsii cheloveka" Sibirskogo otdeleniia RAMN, Irkutsk
Neznanov N.G.
Sankt-Peterburgskiĭ gosudarstvennyĭ meditsinskiĭ universitet im. I.P. Pavlova;
Sankt-Peterburgskiĭ nauchno-issledovatel'skiĭ psikhonevrologicheskiĭ institut im. V.M. Bekhtereva;
fakul'tet psikhiatrii Universiteta shtata Pensil'vaniia (SShA)
A double blind placebo controlled randomized clinical trial of the efficacy and safety of pregabalin in induction of remission in patients with alcohol dependence
Journal: S.S. Korsakov Journal of Neurology and Psychiatry. 2020;120(1): 33‑43
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To cite this article:
Krupitskiĭ EM, Rybakova KV, Skurat EP, Semenova NV, Neznanov NG. A double blind placebo controlled randomized clinical trial of the efficacy and safety of pregabalin in induction of remission in patients with alcohol dependence. S.S. Korsakov Journal of Neurology and Psychiatry.
2020;120(1):33‑43. (In Russ.)
https://doi.org/10.17116/jnevro202012001133
Objective. To study the efficacy of pregabalin for relapse prevention and reduction of drinking in patients with alcohol dependence. Material and methods. One hundred recently detoxified out-patients with alcohol dependence were randomly assigned to one of two treatment groups. Patients of the first group (n=50; 38 men, 12 women, age 43.0±1.27) received pregabalin (150 mg once a day at night time) for 3 months, while patients of the second group (n=50; 45 men, 5 women, age 45.92±1.4) received identically looking placebo. All patients received standardized manualized weekly counseling (medical management). Drinking was measured on the weekly basis with Time Line Follow Back technique and GGT enzyme activity. Also, craving for alcohol, depression, and anxiety were measured weekly with the number of scales. Results. Kaplan—Meier survival analysis demonstrated significantly higher retention in treatment and in remission in the pregabalin group (lower drop out and relapse rate) mediana (CL)-12 (10.4—13.6) weeks in the pregabalin group vs. 6 (4.5—7.5) in the placebo group, Log Rank Mantel-Cox test = 0.005). Proportion of patients, who completed treatment in the pregabalin group, was significantly higher compared to the placebo group: 50% vs. 24%. Mean duration of participation in the treatment program was also higher in the pregabalin group: 9.1±0.5 weeks vs. 7.1±0.5 in the placebo group. General linear model demonstrated the significant treatment group effect on: (1) total alcohol consumption (TAC) (mean grams of alcohol per day) with lower TAC in the pregabalin group and (2) on the number of heavy drinking days (NHDD) with lower NHDD in the pregabalin group. Mean NHDD per patient for the period of participation in the study was lower in the pregabalin group (3.6±0.7 vs. 6.4±0.8; p=0.009), while the mean number of abstinent (sober) days was higher (55.9±3.6 vs. 40.0±3.3; p=0.001). No significant differences between the two groups were found in the scores on craving for alcohol, depression and anxiety scales. GGT activity was also similar in both groups throughout the study with no significant between group differences. The rate of adverse events (sleepiness, dizziness, and headache) was insignificantly higher in the pregabalin group compared with the placebo group. All adverse events were mild, gradually disappeared, and did not require any medication. Conclusion. Results of this study provide evidence that pregabalin in a low dose of 150 mg per day is an effective and safe medication for relapse prevention and reduction of drinking in patients with alcohol dependence.
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Krupitskiĭ E.M.
Sankt-Peterburgskiĭ nauchno-issledovatel'skiĭ psikhonevrologicheskiĭ institut im. V.M. Bekhtereva
Rybakova K.V.
Sankt-Peterburgskiĭ nauchno-issledovatel'skiĭ psikhonevrologicheskiĭ institut im. V.M. Bekhtereva, Sankt-Peterburg
Skurat E.P.
St. Petersburg V.M. Bekhterev Research Psychoneurological Institute, St. Peterburg, Russia
Semenova N.V.
FGBU "Nauchnyĭ tsentr problem zdorov'ia sem'i i reproduktsii cheloveka" Sibirskogo otdeleniia RAMN, Irkutsk
Neznanov N.G.
Sankt-Peterburgskiĭ gosudarstvennyĭ meditsinskiĭ universitet im. I.P. Pavlova;
Sankt-Peterburgskiĭ nauchno-issledovatel'skiĭ psikhonevrologicheskiĭ institut im. V.M. Bekhtereva;
fakul'tet psikhiatrii Universiteta shtata Pensil'vaniia (SShA)
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