A randomised, double-blind, placebo-controlled, efficacy study of nalmefene, as-needed use, in patients with alcohol dependence

European Neuropsychopharmacology

Volumn 23, Issue 11, 2013, Pages 1432-1442

  Gual, Antoni ^a   He, Yuan ^b   Torup, Lars ^b   van den Brink, Wim ^c   Mann, Karl ^d  

^a HOSPITAL CLÍNIC   (Spain)

^b H LUNDBECK A S   (Denmark)

^c UNIVERSITY OF AMSTERDAM   (Netherlands)

^d UNIVERSITY OF HEIDELBERG   (Germany)

Author keywords

Alcohol dependence; As needed; Harm reduction; Nalmefene; Opioid antagonist; Treatment

Indexed keywords

ALANINE AMINOTRANSFERASE; ALCOHOL; GAMMA GLUTAMYLTRANSFERASE; LIVER ENZYME; NALMEFENE; PLACEBO;

ADULT; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ALCOHOL CONSUMPTION; ALCOHOLISM; ANXIETY; ARTICLE; CLINICAL GLOBAL IMPRESSION SCALE; CONTROLLED STUDY; DEPRESSION; DIARRHEA; DISEASE SEVERITY; DIZZINESS; DOUBLE BLIND PROCEDURE; DRINKING BEHAVIOR; DRUG EFFICACY; DRUG OVERDOSE; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; GAMMA GLUTAMYL TRANSFERASE BLOOD LEVEL; HARM REDUCTION; HEADACHE; HUMAN; INSOMNIA; LIVER FUNCTION TEST; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NAUSEA; PATIENT COMPLIANCE; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; PROFILE OF MOOD STATES; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; SIDE EFFECT; SUICIDAL BEHAVIOR; TREATMENT OUTCOME; VOMITING;

ALCOHOL DEPENDENCE; AS-NEEDED; HARM-REDUCTION; NALMEFENE; OPIOID ANTAGONIST; TREATMENT;

ADULT; ALCOHOL DRINKING; ALCOHOLISM; DOUBLE-BLIND METHOD; FEMALE; HUMANS; MALE; MIDDLE AGED; NALTREXONE; NARCOTIC ANTAGONISTS; TREATMENT OUTCOME;

EID: 84886798117     PISSN: 0924977X     EISSN: 18737862     Source Type: Journal    
DOI: 10.1016/j.euroneuro.2013.02.006     Document Type: Article

References (46)

1. Adamson S.J., Heather N., Morton V., Raistrick D., UKATT Research Team Initial preference for drinking goal in the treatment of alcohol problems: II. Treatment outcomes. Alcohol Alcohol. 2010, 45:136-142.
2. Alonso J., Angermeyer M.C., Bernert S., Bruffaerts R., Brugha T.S., Bryson H., et al. Use of mental health services in Europe: results from the European Study of the Epidemiology of Mental Disorders (ESEMeD) project. Acta. Psychiatr. Scand. Suppl. 2004, 109(suppl 420):47-54.
3. American Psychiatric Association (APA) Diagnostic and Statistical Manual of Mental Disorders, Fourth Ed., Text Revision (DSM-IV-TR) 2000, American Psychiatric Association, Washington DC.
4. Anton R.F., Pettinati H., Zweben A., Kranzler H.R., Johnson B., Bohn M.J., et al. A multi-site dose ranging study of nalmefene in the treatment of alcohol dependence. J. Clin. Psychopharmacol. 2004, 24:421-428.
5. Anton R.F., O'Malley S.S., Ciraulo D.A., Cisler R.A., Couper D., Donovan D.M., et al. Combined pharmacotherapies and behavioral interventions for alcohol dependence: the COMBINE study: a randomized controlled trial. J. Am. Med. Assoc. 2006, 295:2003-2017.
6. Epstein E.E., Drapkin M.L., Yusko D.A., Cook S.M., McCrady B.S., Jensen N.K. Is alcohol assessment therapeutic? Pretreatment change in drinking among alcohol-dependent women. J. Stud. Alcohol 2005, 66:369-378.
7. European Medicines Agency (EMEA), 2010. Guideline on the development of medicinal products for the treatment of alcohol dependence. EMEA/CHMP/EWP/20097/2008.
8. Garbutt J.C., Kranzler H.R., O'Malley S.S., Gastfriend D.R., Pettinati H.M., Silverman B.L, for the Vivitrex Study Group, et al. Efficacy and tolerability of long-acting injectable naltrexone for alcohol dependence a randomized controlled trial. J. Am. Med. Assoc. 2005, 293:1617-1625.
9. Gastfriend D.R., Garbutt J.C., Pettinati H.M., Forman R.F. Reduction in heavy drinking as a treatment outcome in alcohol dependence. J. Subst. Abuse Treat. 2007, 33:71-80.
10. 1976, National Institute of Mental Health, Rockville, MD, Publication no. 76-338. W. Guy (Ed.).
11. Heather N., Adamson S.J., Raistrick D., Slegg G.P., UKATT Research Team Initial preference for drinking goal in the treatment of alcohol problems: I. Baseline differences between abstinence and non-abstinence groups. Alcohol Alcohol. 2010, 45:128-135.
12. Heinälä P., Alho H., Kiianmaa K., Lönnqvist J., Kuoppasalmi K., Sinclair J.D. Targeted use of naltrexone without prior detoxification in the treatment of alcohol dependence: a factorial double-blind, placebo-controlled trial. J. Clin. Psychopharmacol. 2001, 21:287-292.
13. Johnson B.A., Ait-Daoud N., Bowden C.L., DiClemente C.C., Roache J.D., Lawson K., et al. Oral topiramate for treatment of alcohol dependence: a randomised controlled trial. Lancet 2003, 361:1677-1685.
14. Karhuvaara S., Simojoki K., Virta A., Rosberg M., Löyttyniemi E., Nurminen T., et al. Targeted nalmefene with simple medical management in the treatment of heavy drinkers: a randomized double-blind placebo-controlled multicenter study. Alcohol. Clin. Exp. Res. 2007, 31:1179-1187.
15. Kranzler H.R., Tennen H., Penta C., Bohn M.J. Targeted naltrexone treatment of early problem drinkers. Addict. Behav. 1997, 22:431-436.
16. Kranzler H.R., Armeli S., Tennen H., Blomqvist O., Oncken C., Petry N., et al. Targeted naltrexone for early problem drinkers. J. Clin. Psychopharmacol. 2003, 23:294-304.
17. Kranzler H.R., Tennen H., Armeli S., Chan G., Covault J., Arias A., et al. Targeted naltrexone for problem drinkers. J. Clin. Psychopharmacol. 2009, 29:350-357.
18. Laaksonen E., Koski-Jännes A., Salaspuro M., Ahtinen H., Alho H. A randomized, multicentre, open-label, comparative trial of disulfiram, naltrexone and acamprosate in the treatment of alcohol dependence. Alcohol Alcohol. 2008, 43:53-61.
19. Lecrubier Y., Sheehan D.V., Weiller E., Amorim P., Bonora I., Harnett Sheehan K., et al. The Mini International Neuropsychiatric Interview (MINI). A short diagnostic structured interview: reliability and validity according to the CIDI. Eur. Psychiatry 1997, 12:224-231.
20. Litten R.Z., Fertig J.B., Falk D.E., Ryan M.L., Mattson M.E., Collins J.F., et al. A double-blind, placebo controlled trial to assess the efficacy of Quetiapine Fumarate XR in very heavy-drinking alcohol dependent patients. Alcohol. Clin. Exp. Res. 2012, 36:406-416.
21. Little R, Yau L. Intent-to-treat analysis for longitudinal studies with drop-outs. Biometrics 1996, 52:1324-1333.
22. Luquiens A., Reynaud M., Aubin H.J. Is controlled drinking an acceptable goal in the treatment of alcohol dependence? A survey of French alcohol specialists. Alcohol Alcohol. 2011, 46:586-591.
23. Mann K., Lehert P., Morgan M.Y. 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.
24. Mann K., Bladström A., Torup L., Gual A., van den Brink W. Extending the treatment options in alcohol dependence: a randomized controlled study of as-needed nalmefene. Biol. Psychiatry 2013, 73:706-713.
25. Marlatt G.A., Witkiewitz K. Harm reduction approaches to alcohol use: health promotion, prevention, and treatment. Addict. Behav. 2002, 27:867-886.
26. Mason B.J., Ritvo E.C., Morgan R.O., Salvato F.R., Goldberg G., Welch B., et al. A double-blind, placebo-controlled pilot study to evaluate the efficacy and safety of oral nalmefene HCl for alcohol dependence. Alcohol. Clin. Exp. Res. 1994, 18:1162-1167.
27. Mason B.J., Salvato F.R., Williams L.D., Ritvo E.C., Cutler R.B. A double-blind, placebo-controlled study of oral nalmefene for alcohol dependence. Arch. Gen. Psychiatry 1999, 56:719-724.
28. Merkx M.J., Schippers G.M., Koeter M.W., Vuijk P.J., Oudejans S.C., Stam R.K., et al. Guidelines for allocating outpatient alcohol abusers to levels of care: predictive validity. Addict. Behav. 2011, 36:570-575.
29. 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, National Institute on Alcohol Abuse and Alcoholism, Rockville, MD.
30. Miller W.R., Walters S.T., Bennett M.E. How effective is alcoholism treatment in the United States?. J. Stud. Alcohol 2001, 62:211-220.
31. Project MATCH Research Group Matching alcoholism treatments to client heterogeneity: project MATCH three-year drinking outcomes. Alcohol. Clin. Exp. Res. 1998, 22:1300-1311.
32. Rehm J., Mathers C., Popova S., Thavorncharoensap M., Teerawattananon Y., Patra J. Global burden of disease and injury and economic cost attributable to alcohol use and alcohol-use disorders. Lancet 2009, 373:2223-2233.
33. Rehm J., Baliunas D., Borges G.L., Graham K., Irving H., Kehoe T., et al. The relation between different dimensions of alcohol consumption and burden of disease: an overview. Addiction 2010, 105:817-843.
34. Rehm J., Zatonksi W., Taylor B., Anderson P. Epidemiology and alcohol policy in Europe. Addiction 2011, 106(Suppl 1):11-19.
35. Rehm J., Shield K.D., Rehm M.X., Gmel G., Frick U. Modelling the impact of alcohol dependence on mortality burden and the effect of available treatment interventions in the European Union. Eur. Neuropsychopharmacol. 2013, 23:89-97.
36. Sinclair J.D. Evidence about the use of naltrexone and for different ways of using it in the treatment of alcoholism. Alcohol Alcohol. 2001, 36:2-10.
37. Skinner H.A., Horn J.L. Alcohol Dependence Scale: Users Guide 1984, Addiction Research Foundation, Toronto.
38. Sobell L.C., Sobell M.B. Timeline Follow-back: a technique for assessing self-reported ethanol consumption. Measuring Alcohol Consumption: Psychosocial and Biological Method 1992, Humana Press, Totowa, NJ, pp 41-72. R.Z. Litten, J.P. Allen (Eds.).
39. Starosta A.N., Leeman R.F., Volpicelli J.R. The BRENDA model: integrating psychosocial treatment and pharmacotherapy for the treatment of alcohol use disorders. J. Psychiatr. Pract. 2006, 12:80-89.
40. Sullivan J.T., Sykora K., Schneiderman J., Naranjo C.A., Sellers E.M. Assessment of alcohol withdrawal: the revised clinical institute withdrawal assessment for alcohol scale (CIWA-Ar). Br. J. Addict. 1989, 84:1353-1357.
41. Volpicelli J.R., Pettinati H.M., McLellan A.T., O'Brien C.P. Combining Medication and Psychosocial Treatments for Addictions; the BRENDA Approach 2001, The Guilford Press, New York, NY.
42. Willenbring M.L., Massey S.H., Gardner M.B. Helping patients who drink too much: an evidence-based guide for primary care clinicians. Am. Fam. Physician 2009, 80:44-50.
43. Wittchen H.U., Jacobi F., Rehm J., Gustavsson A., Svensson M., Jönsson B., et al. The size and burden of mental disorders and other disorders of the brain in Europe 2010. Eur. Neuropsychopharmacol. 2011, 21:655-679.
44. World Health Organisation (WHO), 2000. International Guide for Monitoring Alcohol Consumption and Related Harm. WHO/MSD/MSB/00.4.
45. World Health Organisation (WHO), 2010. Global Strategy to Reduce the Harmful use of Alcohol.
46. World Health Organisation (WHO), 2011. Global Status Report on Alcohol and Health.