A randomized, double-blind, placebo-controlled clinical trial of acamprosate in alcohol-dependent individuals with bipolar disorder: A preliminary report

Bipolar Disorders

Volumn 14, Issue 1, 2012, Pages 54-63

  Tolliver, Bryan K ^a   Desantis, Stacia M ^a   Brown, Delisa G ^a   Prisciandaro, James J ^a   Brady, Kathleen T ^a,b  

^a MEDICAL UNIVERSITY OF SOUTH CAROLINA   (United States)

^b RALPH H JOHNSON VA MEDICAL CENTER   (United States)

Author keywords

Acamprosate; Addiction; Alcohol; Bipolar disorder; Craving; Depression; Glutamate; Mania

Indexed keywords

ACAMPROSATE; ALANINE AMINOTRANSFERASE; ANTICONVULSIVE AGENT; ANTIDEPRESSANT AGENT; ASPARTATE AMINOTRANSFERASE; BENZODIAZEPINE DERIVATIVE; BIOLOGICAL MARKER; CARBOHYDRATE DEFICIENT TRANSFERRIN; GAMMA GLUTAMYLTRANSFERASE; LITHIUM; NEUROLEPTIC AGENT; PLACEBO;

ADD ON THERAPY; ADULT; ALCOHOL CONSUMPTION; ALCOHOLISM; ANAPHYLACTOID SKIN REACTION; ANAPHYLAXIS; ARTICLE; BIPOLAR I DISORDER; BIPOLAR II DISORDER; CLINICAL ARTICLE; CLINICAL GLOBAL IMPRESSION SCALE; CONSTIPATION; CONTROLLED STUDY; DEPRESSION; DIARRHEA; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG ERUPTION; DRUG INDUCED HEADACHE; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSPEPSIA; FEMALE; HUMAN; MALE; MANIA; NAUSEA; PAIN; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SKIN MANIFESTATION; SUICIDAL IDEATION; TREATMENT DURATION; TREMOR; WITHDRAWAL SYNDROME;

ADULT; AFFECT; ALCOHOL DETERRENTS; ALCOHOLISM; BIPOLAR DISORDER; DOUBLE-BLIND METHOD; FEMALE; HUMANS; MALE; MIDDLE AGED; TAURINE;

EID: 84863393394     PISSN: 13985647     EISSN: 13995618     Source Type: Journal    
DOI: 10.1111/j.1399-5618.2011.00973.x     Document Type: Article

References (48)

1. Regier DA, Farmer ME, Rae DS et al. Comorbidity of mental disorders with alcohol and other drug abuse. Results from the Epidemiologic Catchment Area (ECA) Study. JAMA 1990; 264: 2511-2518.
2. Kessler RC, Crum RM, Warner LA, Nelson CB, Schulenberg J, Anthony JC. Lifetime co- occurrence of DSM-III-R alcohol abuse and dependence with other psychiatric disorders in the National Comorbidity Survey. Arch Gen Psychiatry 1997; 54: 313-321.
3. Grant BF, Stinson FS, Dawson DA et al. Prevalence and co-occurrence of substance use disorders and independent mood and anxiety disorders: results from the National Epidemiologic Survey on Alcohol and Related Conditions. Arch Gen Psychiatry 2004; 61: 807-816.
4. Hasin DS, Stinson FS, Ogburn E, Grant BF. Prevalence, correlates, disability, and comorbidity of DSM-IV alcohol abuse and dependence in the United States: results from the National Epidemiologic Survey on Alcohol and Related Conditions. Arch Gen Psychiatry 2007; 64: 830-842.
5. Merikangas KR, Akiskal HS, Angst J et al. Lifetime and 12-month prevalence of bipolar spectrum disorder in the National Comorbidity Survey replication. Arch Gen Psychiatry 2007; 64: 543-552.
6. Tohen M, Greenfield SF, Weiss RD, Zarate CA Jr, Vagge LM. The effect of comorbid substance use disorders on the course of bipolar disorder: a review. Harv Rev Psychiatry 1998; 6: 133-141.
7. Himmelhoch JM, Mulla D, Neil JF, Detre TP, Kupfer DJ. Incidence and signficiance of mixed affective states in a bipolar population. Arch Gen Psychiatry 1976; 33: 1062-1066.
8. Keller MB, Lavori PW, Coryell W et al. Differential outcomes of pure manic, mixed/cycling, and pure depressive episodes in patients with bipolar illness. JAMA 1986; 255: 3138-3142.
9. Sonne SC, Brady KT, Morton WA. Substance abuse and bipolar affective disorder. J Nerv Ment Disease 1994; 182: 349-352.
10. Goldberg JF, Garno JL, Leon AC, Kocsis JH, Portera L. A history of substance abuse complicates remission from acute mania in bipolar disorder. J Clin Psychiatry 1999; 60: 733-740.
11. Weiss RD, Ostacher MJ, Otto MW et al. Does recovery from substance use disorder matter in patients with bipolar disorder? J Clin Psychiatry 2005; 66: 730-735.
12. Hawton K, Sutton L, Haw C, Sinclair J, Harriss L. Suicide and attempted suicide in bipolar disorder: a systematic review of risk factors. J Clin Psychiatry 2005; 66: 693-704.
13. Swann AC, Dougherty DM, Pazzaglia PJ, Pham M, Steinberg JL, Moeller FG. Increased impulsivity associated with severity of suicide attempt history in patients with bipolar disorder. Am J Psychiatry 2005; 162: 1680-1687.
14. Feinman JA, Dunner DL. The effect of alcohol and substance abuse on the course of bipolar affective disorder. J Affect Disord 1996; 37: 43-49.
15. Potash JB, Kane HS, Chiu YF et al. Attempted suicide and alcoholism in bipolar disorder: clinical and familial relationships. Am J Psychiatry 2000; 157: 2048-2050.
16. Himmelhoch JM, Garfinkel ME. Sources of lithium resistance in mixed mania. Psychopharmacol Bull 1986; 22: 613-620.
17. Frye MA, Salloum IM. Bipolar disorder and comorbid alcoholism: prevalence rate and treatment considerations. Bipolar Disord 2006; 8: 677-685.
18. Singh JB, Zarate CA Jr. Pharmacological treatment of psychiatric comorbidity in bipolar disorder: a review of controlled trials. Bipolar Disord 2006; 8: 696-709.
19. Salloum IM, Cornelius JR, Daley DC, Kirisci L, Himmelhoch JM, Thase ME. Efficacy of valproate maintenance in patients with bipolar disorder and alcoholism: a double-blind placebo-controlled study. Arch Gen Psychiatry 2005; 62: 37-45.
20. Brown ES, Carmody TJ, Schmitz JM et al. A randomized, double-blind, placebo-controlled pilot study of naltrexone in outpatients with bipolar disorder and alcohol dependence. Alcohol Clin Exp Res 2009; 33: 1863-1869.
21. Petrakis IL, Poling J, Levinson C et al. Naltrexone and disulfiram in patients with alcohol dependence and comorbid psychiatric disorders. Biol Psychiatry 2005; 57: 1128-1137.
22. Tolliver B, McRae A, Sonne SC, Brady KT. Safety and tolerability of acamprosate in alcohol- dependent individuals with bipolar disorder. An open-label pilot study. Addict Disord Treatment 2009; 8: 33-38.
23. DeWitte P, Littleton J, Parot P, Koob G. Neuroprotective and abstinence-promoting effects of acamprosate. Elucidating the mechanism of action. CNS Drugs 2005; 19: 517-537.
24. Umhau JC, Momenan R, Schwandt ML et al. Effect of acamprosate on magnetic resonance spectroscopy measures of central glutamate in detoxified alcohol- dependent individuals. Arch Gen Psychiatry 2010; 67: 1069-1077.
25. Dager SR, Friedman SD, Parow A et al. Brain metabolic alterations in medication-free patients with bipolar disorder. Arch Gen Psychiatry 2004; 61: 450-458.
26. Frye MA, Watzl J, Banakar S et al. Increased anterior cingulate/medial prefrontal cortical glutamate and creatine in bipolar depression. Neuropsychopharmacol 2007; 32: 2490-2499.
27. Ongur D, Jensen JE, Prescot AP et al. Abnormal glutamatergic neurotransmission and neuronal- glial interactions in acute mania. Biol Psychiatry 2008; 64: 718-726.
28. Diazgranados N, Ibrahim L, Brutsche NE et al. A randomized add-on trial of an N-methyl-D- aspartate antagonist in treatment-resistent bipolar depression. Arch Gen Psychiatry 2010; 67: 793-802.
29. Simon NM, Otto MW, Weiss RD, Bauer MS, Miyahara S, Wisniewski SR. Pharmacotherapy for bipolar disorder and comorbid conditions. Baseline data from STEP-BD. J Clin Psychopharmacol 2004; 24: 512-520.
30. Moher D, Schulz KF, Altman D. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. JAMA 2001; 285: 1987-1991.
31. First MB, Spitzer RL, Gibbon M et al. User's Guide for the Structured Clinical Interview for DSM- IV. Washington, D.C.: American Psychiatric Press, 1997.
32. Sheehan DV, Lecrubier Y, Harnett-Sheehan K et al. The Mini International Neuropsychiatric Interview (M.I.N.I.): The Development and Validation of a Structured Diagnostic Psychiatric Interview. J Clin Psychiatry 1998; 59 (Suppl. 20): 22-23.
33. Anton RF, Lieber C, Tabakoff B. Carbohydrate-deficient transferrin and gamma- glutamyltransferase for the detection and monitoring of alcohol use: results from a multisite study. Alcohol Clin Exp Res 2002; 26: 1215-1222.
34. Anton RF, O'Malley SS, Ciraulo DA et al. Combined pharmacotherapies and behavioral interventions for alcohol dependence: the COMBINE study: a randomized controlled trial. JAMA 2006; 295: 2003-2017.
35. Sobell LC, Sobell MB. Timeline Followback User's Guide: A Calendar Method for Assessing Alcohol and Drug Use. Toronto: Addiction Research Foundation, 1996.
36. Anton RF, Moak DH, Latham PK. The obsessive compulsive drinking scale: a new method of assessing outcome in alcoholism treatment studies. Archiv Gen Psychiatry 1996; 53: 225-231.
37. Montgomery SA, Åsberg M. A new depression scale designed to be sensitive to change. Br J Psychiatry 1979; 134: 382-389.
38. Young RC, Biggs JT, Ziegler VE, Meyer DA. A rating scale for mania: reliability, validity and sensitivity. Br J Psychiatry 1978; 133: 429-435.
39. Guy W. ECDEU Assessment Manual for Psychopharmacology. Rockville: U.S. Department of Health, Education, and Welfare, 1976.
40. Mann K, Lehert P, Morgan MY. The efficacy of acamprosate in the maintenance of abstinence in alcohol-dependent individuals: results of a meta-analysis. Alcohol Clin Exp Res 2004; 28: 51-63.
41. Saivin S, Hulot T, Chabac S et al. Clinical pharmacokinetics of acamprosate. Clin Pharmacokinet 1998; 35: 331-345.
42. Nery FG, Stanley JA, Chen H-H et al. Bipolar disorder comorbid with alcoholism: a 1H magnetic resonance spectroscopy study. J Psychiatric Res 2010; 44: 278-285.
43. Chick J, Howlett H, Morgan MY, Ritson B. United Kingdom multicentre acamprosate study (UKMAS): a 6-month prospective study of acamprosate versus placebo in preventing relapse after withdrawal from alcohol. Alcohol Alcohol 2000; 35: 176-187.
44. Mason BJ, Goodman AM, Chabac S, Lehert P. Effect of oral acamprosate on abstinence in patients with alcohol dependence in a double-blind, placebo-controlled trial: the role of patient motivation. J Psychiatric Res 2006; 40: 383-393.
45. Kranzler HR, Van Kirk J. Efficacy of naltrexone and acamprosate for alcoholism treatment: a meta-analysis. Alcohol Clin Exp Res 2001; 25: 1335-1341.
46. Verhuel R, Lehert P, Geerlings PJ, Koeter MWJ, van den Brink W. Predictors of acamprosate efficacy: results from a pooled analysis of seven European trials including 1485 alcohol- dependent patients. Psychopharmacology 2005; 178: 167-173.
47. Kraemer HC, Mintz J, Noda A, Tinklenberg J, Yesavage JA. Caution regarding the use of pilot studies to guide power calculations for study proposals. Arch Gen Psychiatry 2006; 63: 484-489.
48. Mann K, Kiefer F, Smolka M, Gann H, Wellek S, Heinz A. Searching for responders to acamprosate and naltrexone in alcoholism treatment: rationale and design of the PREDICT study. Alcohol Clin Exp Res 2009; 33: 674-683.