A randomized double-blind pilot trial of gabapentin versus placebo to treat alcohol dependence and comorbid insomnia

Alcoholism: Clinical and Experimental Research

Volumn 32, Issue 8, 2008, Pages 1429-1438

  Brower, Kirk J ^a,b   Myra Kim, Hyungjin ^a,d   Strobbe, Stephen ^a,b   Karam Hage, Maher A ^e   Consens, Flavia ^a,c   Zucker, Robert A ^a,b  

^a UNIVERSITY OF MICHIGAN   (United States)

^b UNIVERSITY OF MICHIGAN MEDICAL SCHOOL   (United States)

^c Medical School   (United States)

^d Section on Statistical Genetics   (United States)

^e UNIVERSITY OF TEXAS   (United States)

Author keywords

Alcohol Dependence; Gabapentin; Insomnia; Pharmacotherapy; Relapse

Indexed keywords

GABAPENTIN;

ADULT; ALCOHOLISM; ANAMNESIS; ARTICLE; ATAXIA; BEDTIME DOSAGE; BLOOD SAMPLING; CLINICAL ARTICLE; CLINICAL TRIAL; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG DOSE INCREASE; DRUG DOSE TITRATION; DRUG INDUCED HEADACHE; FEMALE; HUMAN; INDIGESTION; INSOMNIA; MALE; MEMORY DISORDER; MENSTRUATION DISORDER; MUSCLE TWITCH; MYALGIA; PALLOR; PATIENT COMPLIANCE; PHYSICAL EXAMINATION; PILL; PILOT STUDY; PRIORITY JOURNAL; RANDOMIZATION; RANDOMIZED CONTROLLED TRIAL; RELAPSE; SIDE EFFECT; SKIN TINGLING; SOMNOLENCE; STRUCTURED INTERVIEW; TREATMENT DURATION; URINALYSIS; XEROSTOMIA;

ADULT; ALCOHOL DRINKING; ALCOHOLISM; AMINES; ANTIMANIC AGENTS; CYCLOHEXANECARBOXYLIC ACIDS; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; FEMALE; GAMMA-AMINOBUTYRIC ACID; HUMANS; MALE; MIDDLE AGED; PATIENT COMPLIANCE; PILOT PROJECTS; SLEEP INITIATION AND MAINTENANCE DISORDERS; TREATMENT OUTCOME;

EID: 48749116784     PISSN: 01456008     EISSN: 15300277     Source Type: Journal    
DOI: 10.1111/j.1530-0277.2008.00706.x     Document Type: Article

References (62)

1. Alling C, Balldin J, Bokstrom K, Gottfries CG, Karlsson I, Langstrom G (1982) Studies on duration of a late recovery period after chronic abuse of ethanol. A cross-sectional study of biochemical and psychiatric indicators. Acta Psychiatr Scand 66 : 384 397.
2. American Psychiatric Association (2000) DSM-IV-TR: Diagnostic and Statistical Manual of Mental Disorders. 4th ed. Text Revision. American Psychiatric Association, Washington DC.
3. Anton RF, Moak DH, Latham PK (1996) The Obsessive Compulsive Drinking Scale: a new method of assessing outcome in alcoholism treatment studies. Arch Gen Psychiatry 53 : 225 231.
4. Arnedt JT, Conroy D, Rutt J, Aloia MS, Brower KJ, Armitage R (2007) An open trial of cognitive-behavioral treatment for insomnia comorbid with alcohol dependence. Sleep Med 8 : 176 180.
5. Bazil CW, Battista J, Basner RC (2005) Gabapentin improves sleep in the presence of alcohol. J Clin Sleep Med 1 : 284 287.
6. Beydoun A, Uthman BM, Sackellares JC (1995) Gabapentin: pharmacokinetics, efficacy, and safety. Clin Neuropharmacol 18 : 469 481.
7. Bisaga A, Evans SM (2006) The acute effects of gabapentin in combination with alcohol in heavy drinkers. Drug Alcohol Depend 83 : 25 32.
8. Bonnet MH, Banger M, Leweke FM, Specka M, Muller BW, Hashemi T, Nyhuis PW, Kutscher S, Burtscheidt W, Gastpar M (2003) Treatment of acute alcohol withdrawal with gabapentin: results from a controlled two-center trial. J Clin Psychopharmacol 23 : 514 519.
9. Bonnet U, Specka M, Leweke FM, Nyhuis P, Banger M (2007) Gabapentin's acute effect on mood profile - a controlled study on patients with alcohol withdrawal. Prog Neuropsychopharmacol Biol Psychiatry 31 : 434 438.
10. Brower KJ (2001) Alcohol's effects on sleep in alcoholics. Alcohol Res Health 25 : 110 125.
11. Brower KJ (2003) Insomnia, alcoholism and relapse. Sleep Med Rev 7 : 523 539.
12. Carroll K, O'Malley S (1996) Compliance Enhancement: A Manual for the Psychopharmacotherapy of Alcohol Dependence. Yale University, New Haven, CT.
13. Cohn TJ, Foster JH, Peters TJ (2003) Sequential studies of sleep disturbance and quality of life in abstaining alcoholics. Addiction Biology 8 : 455 462.
14. Conroy DA, Todd Arnedt J, Brower KJ, Strobbe S, Consens F, Hoffmann R, Armitage R (2006) Perception of sleep in recovering alcohol-dependent patients with insomnia: relationship with future drinking. Alcohol Clin Exp Res 30 : 1992 1999.
15. Cora-Locatelli G, Greenberg BD, Martin JD, Murphy DL (1998) Rebound psychiatric and physical symptoms after gabapentin discontinuation [letter]. J Clin Psychiatry 59 : 131.
16. Cramer JA, Mattson RH, Prevey ML, Scheyer RD, Ouellette VL (1989) How often is medication taken as prescribed? A novel assessment technique. JAMA 261 : 3273 3277.
17. Currie SR, Clark SHDC, el-Guebaly N (2004a) Randomized controlled trial of brief cognitive-behavioural interventions for insomnia in recovering alcoholics. Addiction 99 : 1121 1132.
18. Currie SR, Clark S, Rimac S, Malhotra S (2003) Comprehensive assessment of insomnia in recovering alcoholics using daily sleep diaries and ambulatory monitoring. Alcohol Clin Exp Res 27 : 1262 1269.
19. Currie SR, Malhotra S, Clark S (2004b) Agreement among subjective, objective, and collateral measures of insomnia in postwithdrawal recovering alcoholics. Behav Sleep Med 2 : 148 161.
20. Danel T, Jeanson R, Touitou Y (2003) Temporal pattern in consumption of the first drink of the day in alcohol-dependent persons. Chronobiol Int 20 : 1093 1102.
21. Dooley DJ, Taylor CP, Donevan S, Feltner D (2007) Ca2+ channel alpha2delta ligands: novel modulators of neurotransmission. Trends Pharmacol Sci 28 : 75 82.
22. Feige B, Scaal S, Hornyak M, Gann H, Riemann D (2007) Sleep electroencephalographic spectral power after withdrawal from alcohol in alcohol-dependent patients. Alcohol Clin Exp Res 31 : 19 27.
23. Feinn R, Tennen H, Kranzler HR (2003) Psychometric properties of the short index of problems as a measure of recent alcohol-related problems. Alcohol Clin Exp Res 27 : 1436 1441.
24. First MB, Spitzer RL, Gibbon M, Williams JBW (1997) Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I), Clinician Version: User's Guide. American Psychiatric Press, Washington DC.
25. Foldvary-Schaefer N, De Leon Sanchez I, Karafa M, Mascha E, Dinner D, Morris HH (2002) Gabapentin increases slow-wave sleep in normal adults. Epilepsia 43 : 1493 1497.
26. Folstein MF, Folstein SE, McHugh PR (1975) "Mini-mental state": A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res 12 : 189 198.
27. Friedmann PD, Herman DS, Freedman S, Lemon SC, Ramsey S, Stein MD (2003) Treatment of sleep disturbance in alcohol recovery: A national survey of addiction medicine physicians. J Addict Dis 22 : 91 103.
28. Garcia-Borreguero D, Larrosa O, de la llave Y, Verger K, Masramon X, Hernandez G (2002) Treatment of restless legs syndrome with gabapentin A double-blind, cross-over study. Neurology 59 : 1573 1579.
29. Hamilton M (1959) The assessment of anxiety states by rating. Br J Med Psychol 32 : 50 55.
30. Irwin M, Gillin JC, Dang J, Weissman J, Phillips E, Ehlers CL (2002) Sleep deprivation as a probe of homeostatic sleep regulation in primary alcoholics. Biol Psychiatry 51 : 632 641.
31. Jenkins CD, Stanton BA, Niemcryk SJ, Rose RM (1988) A scale for the estimation of sleep problems in clinical research. J Clin Epidemiol 41 : 313 321.
32. Karam-Hage M, Brower KJ (2000) Gabapentin treatment for insomnia associated with alcohol dependence [letter]. Am J Psychiatry 157 : 51.
33. Karam-Hage M, Brower KJ (2003) Open pilot study of gabapentin versus trazodone to treat insomnia in alcoholic outpatients. Psychiatry Clin Neurosci 57 : 542 544.
34. Klein-Schwartz W, Shepherd JG, Gorman S, Dahl B (2003) Characterization of gabapentin overdose using a poison center case series. J Toxicol Clin Toxicol 41 : 11 15.
35. Kranzler HR, Escobar R, Lee DK, Meza E (1996a) Elevated rates of early discontinuation from pharmacotherapy trials in alcoholics and drug abusers. Alcohol Clin Exp Res 20 : 16 20.
36. Kranzler HR, Kadden RM, Babor TF, Tennen H, Rounsaville BJ (1996b) Validity of the SCID in substance abuse patients. Addiction 91 : 859 868.
37. Kuzniecky R, Ho S, Pan J, Martin R, Gilliam F, Faught E, Hetherington H (2002) Modulation of cerebral GABA by topiramate, lamotrigine, and gabapentin in healthy adults. Neurology 58 : 368 372.
38. Le Bon O, Murphy JR, Staner L, Hoffmann G, Kormoss N, Kentos M, Dupont P, Lion K, Pelc I, Verbanck P (2003) Double-blind, placebo-controlled study of the efficacy of trazodone in alcohol post-withdrawal syndrome: polysomnographic and clinical evaluations. J Clin Psychopharmacol 23 : 377 383.
39. Legros B, Bazil CW (2003) Effects of antiepileptic drugs on sleep architecture: a pilot study. Sleep Med 4 : 51 55.
40. Mariani JJ, Rosenthal RN, Tross S, Singh P, Anand OP (2006) A randomized, open-label, controlled trial of gabapentin and phenobarbital in the treatment of alcohol withdrawal. Am J Addict 15 : 76 84.
41. Matsuyama JR, Mason BJ, Jue SG (1993) Pharmacists' interventions using an electronic medication-event monitoring device's adherence data versus pill counts. Ann Pharmacother 27 : 851 855.
42. Miller WR (1996) Form 90: A Structured Assessment Interview for Drinking and Related Behaviors. National Institute on Alcohol Abuse and Alcoholism Project MATCH Monograph Series (NIH Publication No. 96-4004 National Institutes of Health, Bethesda, MD.
43. Miller WR, Tonigan JS, Longabaugh R (1995) The Drinker Inventory of Consequences (DrInc): An Instrument for Assessing Adverse Consequences of Alcohol Abuse. National Institute on Alcohol Abuse and Alcoholism Project MATCH Monograph Series (NIH Publication No. 95-3911 National Institutes of Health, Bethesda, MD.
44. Moak DH, Anton RF, Latham PK (1998) Further validation of the Obsessive-Compulsive Drinking Scale (OCDS): relationship to alcoholism severity. Am J Addict 7 : 14 23.
45. Morin CM (1993) Insomnia: Psychological Assessment and Management. Guilford, New York.
46. Myrick H, Anton R, Voronin K, Wang W, Henderson S (2007) A double-blind evaluation of gabapentin on alcohol effects and drinking in a clinical laboratory paradigm. Alcohol Clin Exp Res 31 : 221 227.
47. Norton JW (2001) Gabapentin withdrawal syndrome. Clin Neuropharmacol 24 : 245 246.
48. Pande AC, Davidson JR, Jefferson JW, Janney CA, Katzelnick DJ, Weisler RH, Greist JH, Sutherland SM (1999) Treatment of social phobia with gabapentin: a placebo-controlled study. J Clin Psychopharmacol 19 : 341 348.
49. Pande AC, Pollack MH, Crockatt J, Greiner M, Chouinard G, Lydiard RB, Taylor CB, Dager SR, Shiovitz T (2000) Placebo-controlled study of gabapentin treatment of panic disorder. J Clin Psychopharmacol 20 : 467 471.
50. Pittenger C, Desan PH (2007) Gabapentin abuse, and delirium tremens upon gabapentin withdrawal. J Clin Psychiatry 68 : 483 484.
51. Rao ML, Clarenbach P, Vahlensieck M, Kratzschmar S (1988) Gabapentin augments whole blood serotonin in healthy young men. J Neural Transm 73 : 129 134.
52. Rechtschaffen A, Kales AA (1968) A Manual of Standardized Terminology, Techniques and Scoring System for Sleep Stages of Human Subjects. Government Printing Office (NIH Publication No. 204), Washington, DC.
53. Snyder S, Karacan I, Salis PJ (1981) Effects of disulfiram on the sleep of chronic alcoholics. Curr Alcohol 8 : 159 166.
54. Sobell LC, Sobell MB, Leo GI, Cancilla A (1988) Reliability of a timeline method: assessing normal drinkers' reports of recent drinking and a comparative evaluation across several populations. Br J Addiction 83 : 393 402.
55. Stahl SM (2004) Mechanism of action of alpha2delta ligands: voltage sensitive calcium channel (VSCC) modulators. J Clin Psychiatry 65 : 1033 1034.
56. Staner L, Boeijinga P, Danel T, Gendre I, Muzet M, Landron F, Luthringer R (2006) Effects of acamprosate on sleep during alcohol withdrawal: A double-blind placebo-controlled polysomnographic study in alcohol-dependent subjects. Alcohol Clin Exp Res 30 : 1492 1499.
57. Stout RL, Wirtz PW, Carbonari JP, Del Boca FK (1994) Ensuring balanced distribution of prognostic factors in treatment outcome research. J Stud Alcohol 12 : 70 75.
58. Sullivan JT, Sykora K, Schneiderman J, Naranjo CA, Sellers EM (1989) Assessment of alcohol withdrawal: the revised clinical institute withdrawal assessment for alcohol scale (CIWA-Ar). Br J Addict 84 : 1353 1357.
59. Tran KT, Hranicky D, Lark T, Jacob Nj (2005) Gabapentin withdrawal syndrome in the presence of a taper. Bipolar Disord 7 : 302 304.
60. Victorri-Vigneau C, Guerlais M, Jolliet P (2007) Abuse, dependency and withdrawal with gabapentin: a first case report. Pharmacopsychiatry 40 : 43 44.
61. Voris J, Smith NL, Rao SM, Thorne DL, Flowers QJ (2003) Gabapentin for the treatment of ethanol withdrawal. Substance Abuse 24 : 129 132.
62. Williams JBW (1988) A structured interview guide for the Hamilton Depression Rating Scale. Arch Gen Psychiatry 45 : 742 747.