The efficacy and biobehavioural basis of baclofen in the treatment of alcoholic liver disease (BacALD): Study protocol for a randomised controlled trial

Contemporary Clinical Trials

Volumn 36, Issue 2, 2013, Pages 348-355

  Morley, K C ^a   Leung, S ^a   Baillie, A ^b   Haber, P S ^a,c  

^a UNIVERSITY OF SYDNEY   (Australia)

^b MACQUARIE UNIVERSITY   (Australia)

^c ROYAL PRINCE ALFRED HOSPITAL   (Australia)

Author keywords

Alcohol dependence; Alcoholic liver disease; Baclofen; Cirrhosis; Pharmacotherapy; Randomized controlled trial

Indexed keywords

BACLOFEN;

ADULT; ALCOHOL LIVER DISEASE; ALCOHOLISM; ARTICLE; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; HUMAN; LIVER CIRRHOSIS; MAJOR CLINICAL STUDY; RELAPSE; TREATMENT OUTCOME;

ALCOHOL DEPENDENCE; ALCOHOLIC LIVER DISEASE; BACLOFEN; CIRRHOSIS; PHARMACOTHERAPY; RANDOMIZED-CONTROLLED TRIAL;

ALCOHOL DRINKING; ALCOHOLISM; BACLOFEN; CLINICAL PROTOCOLS; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; GABA-B RECEPTOR AGONISTS; HUMANS; LIVER DISEASES, ALCOHOLIC; TREATMENT OUTCOME;

EID: 84884328795     PISSN: 15517144     EISSN: 15592030     Source Type: Journal    
DOI: 10.1016/j.cct.2013.08.002     Document Type: Article

References (48)

1. Bosetti C., Levi F., Lucchini F., Zatonski W.A., Negri E., La V.C. Worldwide mortality from cirrhosis: an update to 2002. J Hepatol 2007, 46:827-839.
2. Rehn N., Room R., Edwards G.A. Alcohol in the European region - consumption, harm and policies 2001, World Health Organization Regional Office for Europe, Copenhagen.
3. Mann R.E., Smart R.G., Govoni R. The epidemiology of alcoholic liver disease. Alcohol Res Health 2003, 27:209-219.
4. WHO European Status Report on Alcohol and Health 2010, World Health Organization Regional Office for Europe, Copenhagen.
5. Tilg H., Day C.P. Management strategies in alcoholic liver disease. Nat Clin Pract Gastroenterol Hepatol 2007, 4:24-34.
6. Addolorato G., Mirijello A., Leggio L., Ferrulli A., Landolfi R. Management of Alcohol Dependence in Patients with Liver Disease 2013, CNS Drugs, [Mar 1 [Epub ahead of print])].
7. 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 Alcohol Depend 2002, 65:209-220.
8. Addolorato G., Leggio L., Ferrulli A., Cardone S., Vonghia L., Mirijello 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, 370:1915-1922.
9. Gorsane M-A., Kebir O., Hache G., Blecha L., Aubin H-J., Reynaud M., et al. Is baclofen a revolutionary medication in alcohol addiction management? Review and recent updates. Subst Abus 2012, 33:336-349.
10. Addolorato G., Caputo F., Capristo E., Domenicali M., Bernardi M., Janiri L., et al. Baclofen efficacy in reducing alcohol craving and intake: a preliminary double-blind randomised controlled study. Alcohol Alcohol 2002, 37:504-508.
11. Garbutt J.C., Kampov-Polevoy A.B., Gallop R., Kalkajuhl L., Flannery B.A. Efficacy and safety of baclofen for alcohol dependence: a randomized, double-blind, placebo-controlled trial. Alcohol Clin Exp Res 2012, 34:1849-1857.
12. Leggio L., Garbutt J.C., Addolorato G. Effectiveness and safety of baclofen in the treatment of alcohol dependent patients. CNS Neurol Disord Drug Targets 2010, 9:33-44.
13. Addolorato G., Leggio L., Ferrulli A., Cardone S., Bedogni G., Caputo F., et al. Dose-response effect of baclofen in reducing daily alcohol intake in alcohol dependence: secondary analysis of a randomized, double-blind, placebo-controlled trial. Alcohol Alcohol 2011, 46:312-317.
14. Pastor A., Jones D.M., Currie J. High-dose baclofen for treatment-resistant alcohol dependence. J Clin Psychopharmacol 2012, 32:266-268.
15. de Beaurepaire R. Suppression of alcohol dependence using baclofen: a 2-year observational study of 100 patients. F Psychiatry 2012, 3:103.
16. Morley K.C., Teesson M., Sannibale C., Haber P.S. Sample bias from different recruitment strategies in a randomised controlled trial for alcohol dependence. Drug Alcohol Rev 2009, 28:222-229.
17. Leo R.J., Baer D. Delirium associated with baclofen withdrawal: a review of common presentations and management strategies. Psychosomatics 2005, 46:503-507.
18. Morley K.C., Teesson M., Reid S.C., Sannibale C., Thomson C., Phung N., et al. Naltrexone versus acamprosate in the treatment of alcohol dependence: a multi-centre, randomized, double-blind, placebo-controlled trial. Addiction 2006, 101:1451-1462.
19. Reid S.C., Teesson M., Sannibale C., Matsuda M., Haber P.S. The efficacy of compliance therapy in pharmacotherapy for alcohol dependence: a randomized controlled trial. J Stud Alcohol 2005, 66:833-841.
20. Teesson M., Sannibale C., Reid S., Proudfoot H., Gournay K., Haber P. Manual for Compliance Therapy in Alcohol Pharmacotherapy (Sydney, National Drug and Alcohol Research Centre Technical Report No. 157) 2003.
21. Younossi Z.M., Guyatt G., Kiwi M., Boparai N., King D. Development of a disease specific questionnaire to measure health related quality of life in patients with chronic liver disease. Gut 1999, 45:295-300.
22. Zigmond A.S., Snaith R.P. The Hospital Anxiety and Depression Scale. Acta Psychiatr Scand 1983, 67:361-370.
23. Lovibond P., Lovibond S. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther 1995, 33:335-343.
24. Sheehan D.V., Lecrubier Y., Sheehan K.H., Amorim P., Janavs J., Weiller E., et al. The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry 1998, 59:22-33.
25. Edwin N., Peter J.V., John G., Eapen C.E., Graham P.L. Relationship between clock and star drawing and the degree of hepatic encephalopathy. Postgrad Med J 2011, 87:605-611.
26. Folstein M.F., Folstein S.E., McHugh P.R. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res 1975, 12:189-198.
27. Mitrushina M.N., Boone K.L., D'Elia L. Handbook of Normative Data for Neuropsychological Assessment 1999, New York, Oxford University Press.
28. Sobell L.C., Sobell M.B., Leo G.L., Cancilla A. Reliability of a timeline followback method: assessing normal drinkers' reports of recent drinking and a comparative evaluation across several populations. Br J Addict 1988, 83:393-402.
29. Skinner H.A., Allen B.A. Alcohol dependence syndrome: measurement and validation. J Abnorm Psychol 1982, 91:199-209.
30. Flannery B.A., Volpicelli J.R., Pettinati H. Psychometric properties of the Penn Alcohol Craving Scale. Alcohol Clin Exp Res 1999, 28:1289-1295.
31. Miller W.R., Tonigan J.S., Longabaugh R. The Drinker Inventory of Consequences (DrInC): an instrument for assessing adverse consequences of alcohol abuse. Project MATCH Monograph Series 1995, 4. Rockville MD, NIAAA.
32. Miller W.R., Tonigan J.S. Assessing drinker's motivation for change: the Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES). Psychol Addict Behav 1996, 10:81-89.
33. Bastien C.H., Vallieres A., Morin C.M. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med 2001, 2:297-307.
34. Buysse D.J., Reynolds C.F., Monk T.H., Berman S.R., Kupfer D.J. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res 1989, 28:193-213.
35. MacKillop J. Factor structure of the alcohol urge questionnaire under neutral conditions and during a cue-elicited urge state. Alcohol Clin Exp Res 2006, 30:1315-1321.
36. DiClemente C.C., Carbonari J.P., Montgomery R.P.G., Hughes S.O. The Alcohol Abstinence Self-Efficacy Scale. J Stud Alcohol 1994, 55:141-148.
37. Hittner J.B. Factorial validity and equivalency of the Alcohol Expectancy Questionnaire Tension-Reduction Subscale across gender and drinking frequency. J Clin Psychol 1995, 51:563-576.
38. Carver C.S., White T.L. Behavioral inhibition, behavioral activation, and affective responses to impending reward and punishment: the BIS/BAS scales. J Pers Soc Psychol 1994, 67:319-333.
39. Wewers M.E., Rachfal C., Ahijevych K. A psychometric evaluation of a visual analogue scale of craving for cigarettes. West J Nurs Res 1990, 12:672-681.
40. Williams V., Morlock R.J., Feltner D. Psychometric evaluation of a visual analog scale for the assessment of anxiety. Health Qual Life Outcomes 2010, 8:57.
41. Wutzke S.E., Conigrave K.M., Kogler B.E., Saunders J.B., Hall W.D. Longitudinal research: maximising subject follow-up. Drug Alcohol Rev 2000, 19:159-163.
42. Faigle J.W., Keberle H. The chemistry and kinetics of Lioresal. Postgrad Med J 1972, 48(Suppl. 5):9-13.
43. Addolorato G., Leggio L. Safety and efficacy of baclofen in the treatment of alcohol-dependent patients. Curr Pharm Des 2010, 16:2113-2117.
44. Ishikawa A., Ambroggi F., Nicola S.M., Fields H.L. Contributions of the amygdala and medial prefrontal cortex to incentive cue responding. Neuroscience 2008, 155:573.
45. Leggio L., Zywiak W.H., McGeary J.E., Edwards S., Fricchione S.R., Shoaff J.R., et al. A human laboratory pilot study with baclofen in alcoholic individuals. Pharmacol Biochem Behav 2013, 103:784-791.
46. Brower K.J., Aldrich M.S., Robinson E.A.R., Zucker R.A., Greden J.F. Insomnia, self-medication, and relapse to alcoholism. Am J Psych 2001, 1568.
47. Cui R., Li B., Suemaru K., Araki H. The effect of baclofen on alterations in the sleep patterns induced by different stressors in rats. J Pharmacol Sci 2009, 109:518-524.
48. Vienne J., Lecciso G., Constantinescu I., Schwartz S., Franken P., Heinser R., et al. Differential effects of sodium oxybate and baclofen on EEG, sleep, neurobehavioral performance, and memory. Sleep 2012, 35:1071-1084.