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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

Authors:

Krupitskiĭ E.M., Rybakova K.V., Skurat E.P., Semenova N.V., Neznanov N.G.

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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

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References:

  1. Ministry of Health of Russia. Statistical Compendium 2017. Accessed October 22, 2018 (In Russ.). https://www.rosminzdrav.ru/ministry/61/22/stranitsa-979/statisticheskie-i-informatsionnye-materialy/statisticheskiy-sbornik-2017-god
  2. Limosin F. Epidemiologic warnings from studies on alcohol use disorders. Encephale. 2014;40(2):129-135. https://doi.org/10.1016/j.encep.2014.02.005
  3. Grant BF, Goldstein RB, Saha TD, Chou SP, Jung J, Zhang H, Pickering RP, Ruan WJ, Smith SM, Huang B, Hasin DS. Epidemiology of DSM-5 Alcohol Use Disorder: Results From the National Epidemiologic Survey on Alcohol and Related Conditions III. JAMA Psychiatry. 2015;72(8):757-766. https://doi.org/10.1001/jamapsychiatry.2015.0584
  4. Nemtsov AV, Shelygin KV. Alcohol is an essential factor of suicides. Konsul’tativnaya Psikhologiya i Psikhoterapiya. 2016;24(3):164-180. (In Russ.) https://doi.org/10.17759/cpp.2016240310
  5. Laramée P, Kusel J, Leonard S, Aubin HJ, François C, Daeppen JB. The economic burden of alcohol dependence in Europe. Alcohol and Alcoholism. 2013;48(3):259-269. https://doi.org/10.1093/alcalc/agt004
  6. Manthey J, Laramée P, Parrott S, Rehm J. Economic burden associated with alcohol dependence in a German primary care sample: a bottom-up study. BMC Public Health. 2016;16(1):906. https://doi.org/10.1186/s12889-016-3578-8
  7. Jonas DE, Amick HR, Feltner C, Bobashev G, Thomas K, Wines R, Kim MM, Shanahan E, Gass CE, Rowe CJ, Garbutt JC. Pharmacotherapy for adults with alcohol use disorders in outpatient settings: a systematic review and meta-analysis. JAMA. 2014;311(18):1889-1900. https://doi.org/10.1001/jama.2014.3628
  8. Palpacuer C, Duprez R, Huneau A, Locher C, Boussageon R, Laviolle B, Naudet F. Pharmacologically controlled drinking in the treatment of alcohol dependence or alcohol use disorders: a systematic review with direct and network meta-analyses on nalmefene, naltrexone, acamprosate, baclofen and topiramate. Addiction. 2018;113(2):220-237. https://doi.org/10.1111/add.13974
  9. Kranzler HR, Soyka M. Diagnosis and Pharmacotherapy of Alcohol Use Disorder: A Review. JAMA. 2018;320(8):815-824. https://doi.org/10.1001/jama.2018.11406
  10. Krystal JH, Petrakis IL, Krupitsky E, Schutz C, Trevisan L, D’Souza DC. NMDA receptor antagonism and the ethanol intoxication signal: from alcoholism risk to pharmacotherapy. Annals of New York Academy of Sciences. 2003;1003:176-184. https://doi.org/10.1196/annals.1300.010
  11. Krystal JH, Madonick S, Perry E, Gueorguieva R, Brush L, Wray Y, Belger A, D’Souza DC. Potentiation of low dose ketamine effects by naltrexone: potential implications for the pharmacotherapy of alcoholism. Neuropsychopharmacology. 2006;31(8):1793-1800. https://doi.org/10.1038/sj.npp.1300994
  12. Noronha ABC, Cui C, Harris RA, Crabbe JC, eds. Neurobiology of Alcohol Dependence. London, England: Academic Press; 2014.
  13. Bell RL, Hauser SR, McClintick J, Rahman S, Edenberg HJ, Szumlinski KK, McBride WJ. Ethanol-associated changes in glutamate reward neurocircuitry: a minireview of clinical and preclinical genetic findings. Progress in Molecular Biology and Translational Science. 2016;137:41-85. https://doi.org/10.1016/bs.pmbts.2015.10.018
  14. di Volo M, Morozova EO, Lapish CC, Kuznetsov A, Gutkin B. Dynamical ventral tegmental area circuit mechanisms of alcohol-dependent dopamine release. The European Journal of Neuroscence. 2018. https://doi.org/10.1111/ejn.14147
  15. Mason BJ, Quello S, Goodell V, Shadan F, Kyle M, Begovic A. Gabapentin treatment for alcohol dependence: a randomized clinical trial. JAMA Intern Med. 2014;174(1):70-77. https://doi.org/10.1001/jamainternmed.2013.11950
  16. Stahl SM, Porreca F, Taylor CP, Cheung R, Thorpe AF, Clair A. The diverse therapeutic actions of pregabalin: is a single mechanism responsible for several pharmacological activities? Trends in Pharmacological Sciences. 2013;33(6):332-339. https://doi.org/10.1016/j.tips.2013.04.001
  17. Mueller TI, Pagano ME, Rodriguez BF, Bruce SE, Stout RL, Keller MB. Long-term use of benzodiazepines in participants with comorbid anxiety and alcohol use disorders. Alcoholism Clinical & Experimental Research. 2005;29(8):1411-1418. https://doi.org/10.1097/01.alc.0000175016.01790.f1
  18. Schank JR. The neurokinin-1 receptor in addictive processes. The Journal of Pharmacology Experimental Therapeutics. 2014;351(1):2-8. https://doi.org/10.1124/jpet.113.210799
  19. Caputo F, Vignoli T, Tarli C, Domenicali M, Zoli G, Bernardi M, Addolorato G. A brief up-date of the use of sodium oxybate for the treatment of alcohol use disorder. International Journal of Environmental Research and Public Health. 2016;13(3):290. https://doi.org/10.3390/ijerph13030290
  20. Schank JR, Heilig M. Substance P and the Neurokinin-1 Receptor: The New CRF. International Review of Neurobiology. 2017;136:151-175. https://doi.org/10.1016/bs.irn.2017.06.008
  21. van den Brink W, Addolorato G, Aubin HJ, Benyamina A, Caputo F, Dematteis M, Gual A, Lesch OM, Mann K, Maremmani I, Nutt D, Paille F, Perney P, Rehm J, Reynaud M, Simon N, Sӧderplam B, Sommer WH, Walter H, Spanagel R. Efficacy and safety of sodium oxybate in alcohol-dependent patients with a very high drinkingrisk level. Addiction Biology. 2018;23(4):969-986. https://doi.org/10.1111/adb.12645
  22. Greenwald MK. Anti-stress neuropharmacological mechanisms and targets for addiction treatment: A translational framework. Neurobiology of Stress. 2018;11(9):84-104. https://doi.org/10.1016/j.ynstr.2018.08.003
  23. Sobell MB, Sobell LC, Klajner F, Pavan D, Basian E. The reliability of a timeline method for assessing normal drinker college students’ recent drinking history: utility for alcohol research. Addictive Behaviors. 1986;11(2):149-161. https://doi.org/10.1016/0306-4603(86)90040-7
  24. Busner J, Targum SD, Miller DS. The Clinical Global Impressions Scale: Errors in Understanding and Use. Comprehensive Psychiatry. 2009;50:3:257-262. https://doi.org/10.1016/j.comppsych.2008.08.005
  25. Hamilton M. The assessment of anxiety states by rating. British Journal of Clinical Psychology. 1959;32:50-55. Accessed October 22, 2018. https://dcf.psychiatry.ufl.edu/files/2011/05/HAMILTON-ANXIETY.pdf
  26. Spielberger CD, Gorsuch RL, Lushene RE. Manual for the state-trait anxiety inventory. Palo Alto, CA: Consulting Press. 1970.
  27. Montgomery SA, Asberg M. A new depression scale designed to be sensitive to change. British Journal of Psychiatry. 1979;134:382-389. https://doi.org/10.1192/bjp.134.4.382
  28. Flannery BA, Volpicelli JR, Pettinati HM. Psychometric properties of the Penn alcohol craving scale. Alcoholism Clinical and Experimental Research. 1999;23(8):1289-1295. https://doi.org/10.1111/j.1530-0277.1999.tb04349.x
  29. Anton RF, Moak DH, Latham PK. The obsessive compulsive drinking scale. Archives of General Psychiatry. 1996;53(3):225-231. https://doi.org/10.1001/archpsyc.1996.01830030047008
  30. Vinnitskaya EV. Alcoholic liver disease: clinical course, therapy. Farmateka. 2007;13(147):53-58. Accessed October 22, 2018 (In Russ.) https://pharmateca.ru/ru/archive/article/6948
  31. Pettinati HM, Weiss RD, Miller WR, Dundon W. Medical management treatment manual: a clinical research guide for medically trained clinicians providing pharmacotherapy as part of the treatment for alcohol dependence. Bethesda, MD: US Department of Health and Human Services. 2004.
  32. Seneviratne C, Johnson B. Advances in medications and tailoring treatment for alcohol use disorder. Alcohol Research: Current Reviews. 2015;37(1):15-28. https://www.arcr.niaaa.nih.gov/arcr371/article02.pdf
  33. Mann K, Kiefer F, Smolka M, Gann H, Wellek S, Heinz A; PREDICT Study Research Team. Searching for responders to acamprosate and naltrexone in alcoholism treatment: rationale and design of the PREDICT study. Alcoholism Clinical & Experimental Research. 2009;33(4):674-683. https://doi.org/10.1111/j.1530-0277.2008.00884.x
  34. Karpyak VM, Biernacka JM, Geske JR, Jenkins GD, Cunningham JM, Rüegg J, Kononenko O, Leontovich AA, Abulseoud OA, Hall-Flavin DK, Loukianova LL, Schneekloth TD, Skime MK, Frank J, Nöthen MM, Rietschel M, Kiefer F, Mann KF, Weinshilboum RM, Frye MA, Choi DS. Genetic markers associated with abstinence length in alcohol-dependent subjects treated with acamprosate. Translational Psychiatry. 2014;4:e462. https://doi.org/10.1038/tp.2014.103
  35. Hillemacher T, Leggio L, Heberlein A. Investigational therapies for the pharmacological treatment of alcoholism. Expert Opinion on Investigational Drugs. 2015;24(1):17-30. https://doi.org/10.1517/13543784.2014.954037
  36. Rao PS, Bell RL, Engleman EA, Sary Y. Targeting glutamate uptake to treat alcohol use disorders. Frontier of Neurocience. 2015;23(9):144. https://doi.org/10.3389/fnins.2015.00144
  37. Goodwani S, Saternos H, Alasmari F, Sari Y. Metabotropic and ionotropic glutamate receptors as potential targets for the treatment of alcohol use disorder. Neuroscience Biobehavioral Reviews. 2017;77:14-31. https://doi.org/10.1016/j.neubiorev.2017.02.024
  38. Falk DE, Ryan ML, Fertig JB, Devine EG, Cruz R, Brown ES, Burns H, Salloum IM, Newport DJ, Mendelson J, Galloway G, Kampman K, Brooks C, Green AI, Brunette KMF, Rosenthal RN, Dunn KE, Strain EC, Ray L, Shoptaw S, Tiouririne NAD, Gunderson EW, Ransom J, Scott C, Leggio L, Caras S, Mason BJ, Litten RZ. Gabapentin enacarbil extended-release for alcohol use disorder: a randomized, double-blind, placebo-controlled, multisite trial assessing efficacy and safety. Alcohol Clinical and Experimental Research. 2019;42(1):158-169. https://doi.org/10.1111/acer.13917
  39. Oulis P, Konstantakopoulos G. Pregabalin in the treatment of alcohol and benzodiazepines dependence. CNS Neuroscience & Therapeutics. 2010;16(1):45-50. https://doi.org/10.1111/j.1755-5949.2009.00120.x
  40. Oulis P, Konstantakopoulos G. Efficacy and safety of pregabalin in the treatment of alcohol and benzodiazepine dependence. Expert Opinion on Investigational Drugs. 2012;21(7):1019-1029. https://doi.org/10.1517/13543784.2012.685651
  41. Guglielmo R, Martinotti G, Clerici M, Janiri L. Pregabalin for alcohol dependence: a critical review of the literature. Advances in Therapy. 2012;29(11):947-957. https://doi.org/10.1007/s12325-012-0061-5
  42. Forg A, Hein J, Volkmar K, Winter M, Richter C, Heinz A, Müller C.A. Efficacy and safety of pregabalin in the treatment of alcohol withdrawal syndrome: a randomized placebo-controlled trial. Alcohol and Alcoholism. 2012;47(2):149-155. https://doi.org/10.1093/alcalc/agr153
  43. Mason BJ, Crean R, Goodell V, Light JM, Quello S, Shadan F, Buffkins K, Kyle M, Adusumalli M, Begovic A, Rao S. A proof-of-concept randomized controlled study of gabapentin: effects on cannabis use, withdrawal and executive function deficits in cannabis-dependent adults. Neuropsychopharmacology. 2012;37(7):1689-1698. https://doi.org/10.1038/npp.2012.14
  44. Kissin MYa, Khalezova NB, Gibitova EA, Tarnorutskaya AV, Ivanov AN. Pregabalin use in HIV-infected patients with opioid dependence syndrome. Obozrenie Psikhiatrii i Meditsinskoi Psikhologii im. V.M. Bekhtereva. 2018;2:70-79. (In Russ.) https://doi.org/10.31363/2313-7053-2018-2-70-79
  45. Papazisis G, Tzachanis D. Pregabalin’s abuse potential: a mini review focusing on the pharmacological profile. International Journal of Clinical Pharmacology and Therapeutics. 2014;52(8):709-716. https://doi.org/10.5414/CP202118
  46. Cairns R, Schaffer AL; Ryan N, Pearson SA, Buckley NA. Rising pregabalin use and misuse in Australia: trends in utilization and intentional poisonings. Addiction. 2018. https://doi.org/10.1111/add.14412
  47. Stannard C. Misuse of gabapentin and pregabalin: a marker for a more serious malaise? Addiction. 2016;111(10):1699-1700. https://doi.org/10.1111/add.13408

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