Baclofen as add-on to standard psychosocial treatment for alcohol dependence: A randomized, double-blind, placebo-controlled trial with 1year follow-up

Journal of Substance Abuse Treatment

Volumn 52, Issue , 2015, Pages 24-30

  Ponizovsky, Alexander M ^a   Rosca, Paola ^a   Aronovich, Edward ^b   Weizman, Abraham ^b   Grinshpoon, Alexander ^c  

^a MINISTRY OF HEALTH   (Israel)

^b TEL AVIV UNIVERSITY   (Israel)

^c TECHNION ISRAEL INSTITUTE OF TECHNOLOGY   (Israel)

Author keywords

Alcohol dependence; Baclofen; Clinical trial

Indexed keywords

BACLOFEN; PLACEBO; 4 AMINOBUTYRIC ACID B RECEPTOR STIMULATING AGENT;

ADD ON THERAPY; ADULT; ALCOHOL ABSTINENCE; ALCOHOL CONSUMPTION; ALCOHOL WITHDRAWAL; ALCOHOLISM; ARTICLE; CHRONOTHERAPY; CLINICAL OBSERVATION; COGNITIVE THERAPY; CONTROLLED STUDY; DEPRESSION; DISTRESS SYNDROME; DRINKING BEHAVIOR; DROWSINESS; DRUG DEPENDENCE TREATMENT; DRUG DOSE INCREASE; DRUG DOSE REGIMEN; DRUG EFFICACY; DRUG INDUCED HEADACHE; DRUG TOLERABILITY; EDUCATION PROGRAM; FEMALE; FOLLOW UP; HUMAN; INTERVENTION STUDY; ISRAEL; MAJOR CLINICAL STUDY; MALE; MEDICATION COMPLIANCE; MOTIVATIONAL INTERVIEWING; PATIENT COMPLIANCE; PRIORITY JOURNAL; PSYCHOSOCIAL CARE; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; SELF CONCEPT; SOCIAL SUPPORT; STANDARD; TREATMENT DURATION; TREATMENT OUTCOME; DOUBLE BLIND PROCEDURE; MIDDLE AGED; MULTIMODALITY CANCER THERAPY; PSYCHOLOGY; PSYCHOTHERAPY;

ADULT; ALCOHOLISM; BACLOFEN; COMBINED MODALITY THERAPY; DOUBLE-BLIND METHOD; FEMALE; FOLLOW-UP STUDIES; GABA-B RECEPTOR AGONISTS; HUMANS; MALE; MIDDLE AGED; PSYCHOTHERAPY; QUALITY OF LIFE; SELF EFFICACY; SOCIAL SUPPORT; TREATMENT OUTCOME;

EID: 84925936487     PISSN: 07405472     EISSN: 18736483     Source Type: Journal    
DOI: 10.1016/j.jsat.2014.11.007     Document Type: Article

References (62)

1. Addolorato G., Caputo F., Capristo E., et al. Baclofen efficacy in reducing alcohol craving and intake: A preliminary double-blind randomized controlled study. Alcohol and Alcoholism 2002, 37:504-508.
2. Addolorato G., Leggio L., Abenavoli L., et al. Baclofen in the treatment of alcohol withdrawal syndrome: A comparative study vs. diazepam. American Journal of Medicine 2006, 119(276):e13-e18.
3. Addolorato G., Leggio L., Agabio R., et al. Baclofen: A new drug for the treatment of alcohol dependence. International Journal of Clinical Practice 2006, 60:1003-1008.
4. Addolorato G., Leggio L., Ferrulli A., Cardone S., Bedogni G., Gasbarrini G., et al. Dose-response effect of baclofen in reducing daily alcohol intake in alcohol-dependent subjects: Secondary analysis of a randomized double-blind placebo controlled trial. Alcohol and Alcoholism 2011, 46:312-317.
5. Addolorato G., Leggio L., Ferrulli A., et al. Effectiveness and safety of baclofen for maintenance of alcohol abstinence in alcohol-dependent patients with liver cirrhosis: Randomised, double-blind controlled study. Lancet 2007, 370(9603):1915-1922.
6. Ameisen O. Case report. Complete and prolonged suppression of symptoms and consequences of alcohol dependence using high-dose baclofen: A self-case report of a physician. Alcohol and Alcoholism 2005, 40:147-150.
7. American Psychiatric Association Diagnostic and statistical manual of mental disorders 2013, American Psychiatric Publishing, Arlington, VA. 5th ed.
8. Anton R.F., Moak D.H., Latham P. The Obsessive Compulsive Drinking Scale: A self-rated instrument for the quantification of thoughts about alcohol and drinking behavior. Alcoholism, Clinical and Experimental Research 1995, 19:92-99.
9. Anton R.F., O'Malley S.S., Ciraulo D.A., et al. Combined pharmacotherapies and behavioral interventions for alcohol dependence: The COMBINE study: A randomized controlled trial. Journal of the American Medical Association 2006, 295:2003-2017.
10. Anton R.E., Randall C.L. Measurement and choice of drinking outcome variables in the COMBINE Study. Journal of Studies on Alcohol. Supplement 2005, 15:104-109.
11. Beck A.T., Beamesderfer A. Assessment of depression: The Depression Inventory. Psychological Measurements in Psychopharmacology. Modern Problems of Pharmacopsychiatry 1974, 7:151-169.
12. Brennan J.L., Leung J.G., Gagliardi J.P., et al. Clinical effectiveness of baclofen for the treatment of alcohol dependence: A review. Clinical Pharmacology 2013, 5:99-107.
13. Bucknam W. Suppression of symptoms of alcohol dependence and craving using high-dose baclofen. Alcohol and Alcoholism 2007, 42:158-160.
14. Colombo G., Addolorato G., Agabio R., et al. Role of GABA(B) receptor in alcohol dependence: Reducing effect of baclofen on alcohol intake and alcohol motivational properties in rats and amelioration of alcohol withdrawal syndrome and alcohol craving in human alcoholics. Neurotoxicity Research 2004, 6:403-414.
15. Cousins M.S., Roberts D.C., de Wit H. GABA (B) receptor agonists for the treatment of drug addiction: A review of recent findings. Drug and Alcohol Dependence 2002, 65:209-220.
16. Davidoff R.A. Antispasticity drugs: Mechanisms of action. Annals of Neurology 1985, 17:107-116.
17. Donovan D., Mattson M.E., Cisler R.A., et al. Quality of life as an outcome measure in alcoholism treatment research. Journal of Studies on Alcohol. Supplement 2005, 15:119-139.
18. Endicott J., Nee J., Harrison W., Blumenthal R. Quality of Life Enjoyment and Satisfaction Questionnaire: A new measure. Psychopharmacology Bulletin 1993, 29:321-326.
19. Fertig J.B., Ryan M.L., Falk D.E., et al. 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 2012, 36:1421-1430.
20. Finniss D.G., Kaptchuk T.J., Miller F., Benedetti F. Biological, clinical, and ethical advances of placebo effects. Lancet 2010, 375(9715):686-695.
21. Flannery B.A., Garbutt J.C., Cody M.W., Renn W., et al. Baclofen for alcohol dependence: A preliminary open-label study. Alcoholism, Clinical and Experimental Research 2004, 28:1517-1523.
22. Garbutt J.C., Kampov-Polevoy A.B., Gallop R. Efficacy and safety of baclofen for alcohol dependence: A randomized, double-blind, placebo controlled trial. Alcoholism, Clinical and Experimental Research 2010, 34:1849-1857.
23. Ginieri-Coccossis M., Liappas I.A., Tzavellas E., et al. Detecting changes in quality of life and psychiatric symptomatology following an in-patient detoxification programme for alcohol-dependent individuals: The use of WHOQOL-100. In Vivo 2007, 21:99-106.
24. Goldberg D.P., Williams P. A users guide to the General Health Questionnaire: GHQ 1988, NFER-NELSON, Windsor.
25. Hallgren K.A., Witkiewitz K. Missing data in alcohol clinical trials: A comparison of methods. Alcoholism, Clinical and Experimental Research 2013, 37:2152-2160.
26. Hedeker D., Gibbons R.D. Longitudinal Data Analysis 2006, John Wiley and Sons, Inc., Hoboken, NJ.
27. Heilig M., Egli M. Pharmacological treatment of alcohol dependence: Target symptoms and target mechanisms. Pharmacology and Therapeutics 2006, 111:855-876.
28. Ho B.C., Nopoulos P., Flaum M., et al. Two-year outcome in first-episode schizophrenia: Predictive value of symptoms for quality of life. American Journal of Psychiatry 1998, 155:1196-1201.
29. Johnson B.A., Ait-Daoud N., Akhtar F.Z., Ma J.Z. Oral topiramate reduces the consequences of drinking and improves the quality of life of alcohol dependent individuals: A randomized controlled trial. Archives of General Psychiatry 2004, 61:905-912.
30. Johnson B.A., Swift R.M., Addolorato G., et al. Safety and efficacy of GABAergic medications for treating alcoholism. Alcoholism, Clinical and Experimental Research 2005, 29:248-254.
31. Khan A., Detke M., Khan S.R., Mallinckrodt C. Placebo response and antidepressant clinical trial outcome. Journal of Nervous and Mental Disease 2003, 191:211-218.
32. Kirsch I., Deacon B.J., Huedo-Medina T.B., et al. Initial severity and antidepressant benefits: A meta-analysis of data submitted to the Food and Drug Administration. PLoS Medicine 2008, 5:e45.
33. Kobak K.A., Leuchter A., DeBrota D., et al. Site versus centralized raters in a clinical depression trial: Impact on patient selection and placebo response. Journal of Clinical Psychopharmacology 2010, 30:193-197.
34. Koivumaa-Honkanen H.T., Honkanen R., Antikainen R., et al. Selfreported life satisfaction and treatment factors in patients with schizophrenia, major depression and anxiety disorder. Acta Psychiatrica Scandinavica 1999, 99:377-384.
35. Litten R.Z., Castle I.J., Falk D., et al. The placebo effect in clinical trials for alcohol dependence: An exploratory analysis of 51 naltrexone and acamprosate studies, Alcoholism. Clinical and Experimental Research 2013, 37:2128-2137.
36. Litten R.Z., Ryan M.L., Fertig J.B., et al. A double-blind, placebo-controlled trial assessing the efficacy of varenicline tartrate for alcohol dependence. Journal of Addiction Medicine 2013, 7:277-286.
37. Liu J., Wang L.N. Baclofen for alcohol withdrawal. Cochrane database of systematic reviews (Online) 2013, 28(2):CD008502.
38. Luquiens A., Reynaud M., Falissard B., Aubin H.J. Quality of life among alcohol-dependent patients: How satisfactory are the available instruments? A systematic review. Drug and Alcohol Dependence 2012, 125:192-202.
39. Mallinckrodt C.H., Zhang L., Prucka W.R., Millen B.A. Signal detection and placebo response in schizophrenia: Parallels with depression. Psychopharmacology Bulletin 2010, 43:53-72.
40. Müller C.A., Geisel O., Banas R., Heinz A. Current pharmacological treatment approaches for alcohol dependence. Expert Opinion on Pharmacotherapy 2014, 15:471-481.
41. Muzyk A.J., Rivelli S.K., Gagliardi J.P. Defining the role of baclofen for the treatment of alcohol dependence: A systematic review of the evidence. CNS Drugs 2012, 26:69-78.
42. Ponizovsky A.M., Grinshpoon A., Margolis A., et al. Well-being, psychosocial factors, and side-effects among heroin-dependent inpatients after detoxification using buprenorphine versus clonidine. Addictive Behaviors 2006, 31:2002-2013.
43. Ritsner M., Ponizovsky A., Endicott J., et al. The impact of adverse events of antipsychotics on life satisfaction of schizophrenia patients: A naturalistic study. European Neuropsychopharmacology 2002, 12:31-38.
44. Rosenberger W.F., Lachin J.M. Randomization in clinical trials: Theory and practice 2002, Wiley, New York.
45. Rosenbloom M.J., Sullivan E.V., Sassoon S.A., et al. Alcoholism, HIV infection, and their comorbidity: Factors affecting self-rated health-related quality of life. Journal of Studies on Alcohol and Drugs 2007, 68:115-125.
46. Saarni S.I., Suvisaari J., Sintonen H., et al. Impact of psychiatric disorders on health-related quality of life: General population survey. British Journal of Psychiatry 1995, 190:326-332.
47. Schwarzer R., Jerusalem M. Generalized self-efficacy scale. Measures in health psychology: A user's portfolio. Causal and control beliefs 1995, 35-37. NFER-NELSON, Windsor, UK. J. Weinman, S. Wright, M. Johnston (Eds.).
48. Sinha R., Li C.S. Imaging stress- and cue-induced drug and alcohol craving: association with relapse and clinical implications. Drug and Alcohol Review 2007, 26:25-31.
49. Sobell L.C., Sobell M.B., Leo G.I., Cancilla A. Reliability of a timeline method: Assessing normal drinkers' reports of recent drinking and a comparative evaluation across several populations. British Journal of Addiction 1988, 83:393-402.
50. Starosta A.N., Leeman R.F., Volpicelli J.R. The BRENDA model: Integrating psychosocial treatment and pharmacotherapy for the treatment of alcohol use disorders. Journal of Psychiatric Practice 2006, 12:80-89.
51. Stewart S.H., Hutson A., Connors G.J. Exploration of the relationship between drinking intensity and quality of life. American Journal on Addictions 2006, 15:356-361.
52. Testa M.A., Simonson D.C. Assessment of quality of life outcomes. New England Journal of Medicine 1996, 334:835-840.
53. Torrens M., Domingo-Salvany A., Alonso J., et al. Methadone and quality of life. Lancet 1999, 353:1101.
54. Torrens M., San L., Martinez A., et al. Use of the Nottingham Health Profile for measuring health status of patients in methadone maintenance treatment. Addiction 1997, 92:707-716.
55. UKATT Research Team Effectiveness of treatment for alcohol problems: Findings of the randomised UK Alcohol Treatment Trial (UKATT). British Medical Journal 2005, 331(7516):541.
56. Walter M., Gerhard U., Duersteler-MacFarland K.M., et al. Social factors but not stress-coping styles predict relapse in detoxified alcoholics. Neuropsychobiology 2006, 54:100-106.
57. Weiss R.D., O'Malley S.S., Hosking J.D., et al. Do patients with alcohol dependence respond to placebo? Results from the COMBINE Study. Journal of Studies on Alcohol and Drugs 2008, 69:878-884.
58. Wilson I.B., Cleary P.D. Linking clinical variables with health-related quality of life. A conceptual model of patient outcomes. Journal of American Medical Association 1995, 273:59-65.
59. World Health Organization The ICD-10 Classification of Mental and Behavioural Disorders 1993, Diagnostic Criteria for Research, Geneva.
60. Zimet G.D., Dahlem N.W., Zimet S.G., et al. The Multidimensional Scale of Perceived Social Support. Journal of Personality Assessment 1988, 52:30-41.
61. Zindel L.R., Kranzler H.R. Pharmacotherapy of alcohol use disorders: Seventy-five years of progress. Journal of Studies on Alcohol and Drugs 2014, 75(Suppl 17):79-88.
62. Zywiak W.H., Stout R.L., Longabaugh R., Dyck I., et al. Relapse-onset factors in Project MATCH: The Relapse Questionnaire. Journal of Substance Abuse Treatment 2006, 31:341-345.