A Double-Blind, Placebo-Controlled Trial Assessing the Efficacy of Levetiracetam Extended-Release in Very Heavy Drinking Alcohol-Dependent Patients

Alcoholism: Clinical and Experimental Research

Volumn 36, Issue 8, 2012, Pages 1421-1430

  Fertig, Joanne B ^a   Ryan, Megan L ^a   Falk, Daniel E ^a   Litten, Raye Z ^a   Mattson, Margaret E ^b   Ransom, Janet ^c   Rickman, William J ^c   Scott, Charles ^c   Ciraulo, Domenic ^d   Green, Alan I ^e   Tiouririne, Nassima A ^f   Johnson, Bankole ^g   Pettinati, Helen ^h   Strain, Eric C ⁱ   Devine, Eric ^d   Brunette, Mary F ^e   Kampman, Kyle ^h   A Tompkins, David ⁱ   Stout, Robert ^j  

^a NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM   (United States)

^b SUBSTANCE ABUSE AND MENTAL HEALTH SERVICES ADMINISTRATION   (United States)

^c Fast Track Drugs and Biologics   (United States)

^d BOSTON UNIVERSITY SCHOOL OF MEDICINE   (United States)

^e DARTMOUTH MEDICAL SCHOOL   (United States)

^f UNIVERSITY OF VIRGINIA   (United States)

^g UNIVERSITY OF VIRGINIA   (United States)

^h UNIVERSITY OF PENNSYLVANIA   (United States)

ⁱ JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^j Pacific Institute for Research and Evaluation   (United States)

more..

Author keywords

Alcohol dependence; Alcohol use disorder; Keppra ; Levetiracetam; Medications development

Indexed keywords

ALCOHOL; ETIRACETAM; GAMMA GLUTAMYLTRANSFERASE; PLACEBO;

ADULT; AGED; ALCOHOL BLOOD LEVEL; ALCOHOL WITHDRAWAL; ALCOHOLISM; ANXIETY; ANXIETY DISORDER; ARTHRALGIA; ARTICLE; BACKACHE; CONTROLLED STUDY; DEPRESSION; DIARRHEA; DIZZINESS; DOUBLE BLIND PROCEDURE; DRINKING BEHAVIOR; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FATIGUE; FEMALE; FOLLOW UP; GAMMA GLUTAMYL TRANSFERASE BLOOD LEVEL; HEADACHE; HUMAN; INSOMNIA; IRRITABILITY; MAJOR CLINICAL STUDY; MALE; MOOD; NAUSEA; PARESTHESIA; PATIENT COMPLIANCE; PRIORITY JOURNAL; PRURITUS; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; SOMNOLENCE; TREATMENT DURATION; UPPER RESPIRATORY TRACT INFECTION; VOMITING;

ADULT; AFFECT; AGED; ALCOHOLISM; ANTICONVULSANTS; ANXIETY; BREATH TESTS; DELAYED-ACTION PREPARATIONS; DEPRESSION; DIAGNOSTIC AND STATISTICAL MANUAL OF MENTAL DISORDERS; DOUBLE-BLIND METHOD; FEMALE; HUMANS; MALE; MIDDLE AGED; NEUROPSYCHOLOGICAL TESTS; PATIENT COMPLIANCE; PIRACETAM; QUALITY OF LIFE; SOCIOECONOMIC FACTORS; TREATMENT OUTCOME;

EID: 84864564520     PISSN: 01456008     EISSN: 15300277     Source Type: Journal    
DOI: 10.1111/j.1530-0277.2011.01716.x     Document Type: Article

References (39)

1. Abou-Khalil B (2008) Levetiracetam in the treatment of epilepsy. Neuropsychiatric Dis Treat 4:507-523.
2. American Psychiatric Association (1994) Diagnostic and Statistical Manual of Mental Disorders. 4th ed [DSM-IV]. American Psychiatric Publishing, Inc., Washington, DC.
3. Anton RF, Myrick H, Baros AM, Latham PK, Randall PK, Wright TM, Stewart SH, Waid R, Malcolm R (2009) Efficacy of a combination of flumazenil and gabapentin in the treatment of alcohol dependence: relationship to alcohol withdrawal symptoms. J Clin Psychopharmacol 29:334-342.
4. Anton RF, Myrick H, Wright TM, Latham PK, Baros AM, Waid LR, Randall PK (2011) Gabapentin combined with naltrexone for the treatment of alcohol dependence. Am J Psychiatry 168:709-717.
5. Arias AJ, Feinn R, Oncken C, Covault J, Kranzler HR (2010) Placebo-controlled trial of zonisamide for the treatment of alcohol dependence. J Clin Psychopharmacol 30:318-322.
6. Book SW, Myrick H (2005) Novel anticonvolusants in the treatment of alcoholism. Expert Opin Investig Drugs 14:371-376.
7. Carunchio I, Pieri M, Ciotti MT, Albo F, Zona C (2007) Modulation of AMPA receptors in cultured cortical neurons induced by the antiepileptic drug levetiracetam. Epilepsia 48:654-662.
8. De Smedt T, Raedt R, Vonck K, Boon P (2007a) Levetiracetam: the profile of a novel anticonvulsant drug-part I: preclinical data. CNS Drug Rev 13:43-56.
9. De Smedt T, Raedt R, Vonck K, Boon P (2007b) Levetiracetam: part II, the clinical profile of a novel anticonvulsant drug. CNS Drug Rev 13:57-78.
10. De Sousa A (2010) The role of topiramate and other anticonvulsants in the treatment of alcohol dependence: a clinical review. CNS Neurol Disord Drug Targets 9(1):45-49.
11. De Wit M, Jones DG, Sessler CN, Zilberberg MD, Weaver MF (2010) Alcohol-use disorders in the critically ill patient. Chest 138:994-1003.
12. Falk D, Wang XQ, Liu L, Fertig J, Mattson M, Ryan M, Johnson B, Stout R, Litten RZ (2010) Percentage of subjects with no heavy drinking days: evaluation as an efficacy endpoint for alcohol clinical trials. Alcohol Clin Exp Res 34:2022-2034.
13. Felter EF, Haig G(2011) Evaluation of the subjective and reinforcing effects of diphenhydramine, levetiracetam, and valproic acid. J Psychopharmacol 25:763-773.
14. Gomer B, Wagner K, Frings L, Saar J, Carius A, Harle M, Steinhoff BJ, Schulze-Bonhage A (2007) The influence of antiepileptic drugs on cognition: a comparison of levetiracetam with topiramate. Epilepsy Behav 10:486-494.
15. Grant BF, Dawson DA, Stinson FS, Chou SP, Dufour MC, Pickering RP (2004) The 12-month prevalence and trends in DSM-IV alcohol abuse and dependence: United States, 1991-1992 and 2001-2002. Drug Alcohol Depend 74:223-234.
16. Guy W (1976) HAMA Hamilton Anxiety Scale, in EDCEU Assessment Manual. U.S. Department of Health and Human Services, Rockville, MD.
17. Heatherton TF, Kozlowski LT, Frecker RC, Fagerstrom K (1991) The Fagerstrom test for nicotine dependence: a revision of the Fagerstrom tolerance questionnaire. Br J Addict 86:1119-1127.
18. International Conference on Harmonisation (1996) ICH E6: Good Clinical Practice: Consolidated guideline. Available at:. Accessed September 21, 2011.
19. Johnson BA (2008) Update on neuropharmacological treatments for alcoholism: scientific basis and clinical findings. Biochem Pharmacol 75:34-75.
20. Johnson BA, Rosenthal N, Capece JA, Wiegand F, Mao L, Beyers K, McKay A, Ait-Daoud N, Anton RF, Ciraulo DA, Kranzler HR, Mann K, O'Malley SS, Swift RM (2007) Topiramate for treating alcohol dependence. JAMA 298:1641-1651.
21. Kaminski RM, Matagne A, Leclercq K, Gillard M, Michel P, Kenda B, Talaga P, Klitgaard H (2008) SV2A protein is a broad-spectrum anticonvulsant target: functional correlation between protein binding and seizure protection in models of both partial and generalized epilepsy. Neuropharmacology 54:715-720.
22. Krebs M, Leopold K, Richter C, Kienast T, Hinzpeter A, Heinz A, Schaefer M (2006) Levetiracetam for the treatment of alcohol withdrawal syndrome: an open-label pilot trial. J Clin Psychopharmacol 26:347-349.
23. Litten RZ, Fertig J, Mattson ME, Egli M (2005) Development of medications for alcohol use disorders: recent advances and ongoing challenges. Expert Opin Emerging Drugs 10:323-343.
24. Mariani JJ, Levin FR (2008) Levetiracetam for the treatment of co-occurring alcohol dependence and anxiety: case series and review. Am J Drug Alcohol Abuse 34:683-691.
25. Miller W (1995) The Drinker Inventory of Consequences (DrInC): an instrument for assessing adverse consequences of alcohol abuse, in NIAAA Project MATCH Monograph Series (Vol. 4) (Mattson M, Marshall LA, eds), pp 1-94. National Institute on Alcohol Abuse and Alcoholism, Bethesda, MD.
26. Miller W (1996) Form 90: A Structured Assessment Interview for Drinking and Related Behaviors (Test Manual). National Institute on Alcohol Abuse and Alcoholism, Bethesda, MD.
27. Miller W, Heather N, Hall W (1991) Calculating standard drink units: international comparisons. Br J Addict 86:43-47.
28. Montgomerty S, Asberg M (1979) A new depression scale designed to be sensitive to change. Br J Psychiatry 134:382-389.
29. Muller CA, Schafer M, Schneider S, Helimann HM, Hinzpeter A, Volkmar K, Forg A, Heinz A, Hein J (2010) Efficacy and safety of levetiracetam for outpatient alcohol detoxification. Pharmacopsychiatry 43:184-189.
30. Perkins DI, Trudell JR, Crawford DK, Alkana RL, Davies DL (2010) Molecular targets and mechanisms for ethanol action in glycine receptors. Pharmacol Therap 127:53-65.
31. Rehm J, Mathers C, Popova S., Thavorncharoensap M, Teerawattananon Y, Patra J (2009) Global burden of disease and injury and economic cost attributable to alcohol use and alcohol-use disorders. Lancet 373:2223-2233.
32. Richter C, Hinzpeter A, Schmidt F, Kienast T, Preuss UW, Plenge T, Heinz A, Schaefer M (2010) Levetiracetam for the treatment of alcohol withdrawal syndrome. J Clin Psychopharmacol 30:720-725.
33. Rigo JM, Hans G, Nguyen L, Rocher V, Belachew S, Malgrange B, Leprince P, Moonen G, Selak I, Matagne A, Klitgaard H (2002) The anti-epileptic drug levetiracetam reverses the inhibition by negative allosteric modulators of neuronal GABA- and glycine-gated currents. Br J Pharmacol 136:659-672.
34. Sanchis-Segura C, Borchardt T, Vengeliene V, Zghoul T, Bachteler D, Gass P, Sprengel R (2006) Involvement of the AMPA receptor GluR-C subunit in alcohol-seeking behavior and relapse. J Neurosci 26:1231-1238.
35. Sarid-Segal O, Piechniczek-Buczek J, Knapp C, Afshar M, Devine E, Sickles L, Uwodukunda E, Richambault C, Koplow J, Ciraulo D (2008) The effects of levetiracetam on alcohol consumption in alcohol-dependent subjects: an open label study. Am J Drug Alcohol Abuse 34:441-447.
36. Sobell L, Sobell M (1992) Timeline follow-back: A technique for assessing self-reported alcohol consumption, in Measuring Alcohol Consumption: Psychosocial and Biochemical Methods (Litten R, Allen J eds), pp 41-72. Humana Press, Totowa, NJ.
37. Sullivan J, Sykora K, Schniederman J, Naranjo C, Sellers E (1989) Assessment of alcohol withdrawal: the revised clinical institute withdrawal assessment for alcohol scale (CIWA-AR). Br J Addict 84:1353-1357.
38. Szabo S (1996) The World Health Organization Quality of Life (WHOQOL), in Quality of Life and Pharmacoeconomics in Clinical Trials (Spiker B, ed), pp 355-362. Lippincott-Raven Publishers, Philadelphia.
39. Zalewska-Kaszubska J, Bajer B, Czarnecka E, Dyr W, Gorska D (2011) Voluntary alcohol consumption and plasma beta-endorphin levels in alcohol preferring rats chronically treated with levetiracetam: a preliminary study. Physiol Behav 102:538-541.