Long-term efficacy, tolerability and safety of nalmefene as-needed in patients with alcohol dependence: A 1-year, randomised controlled study

Journal of Psychopharmacology

Volumn 28, Issue 8, 2014, Pages 733-744

  Van Den Brink, Wim ^a   Sørensen, Per ^b   Torup, Lars ^b   Mann, Karl ^c   Gual, Antoni ^d  

^a UNIVERSITY OF AMSTERDAM   (Netherlands)

^b H LUNDBECK A S   (Denmark)

^c UNIVERSITY OF HEIDELBERG   (Germany)

^d HOSPITAL CLÍNIC   (Spain)

Author keywords

Addiction; adverse effects; alcohol dependence; alcoholism; as needed therapy; Clinical Global Impression; harm reduction; liver enzymes; nalmefene

Indexed keywords

ALCOHOL; NALMEFENE; PLACEBO; NALTREXONE; NARCOTIC ANTAGONIST;

ADULT; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ALCOHOL CONSUMPTION; ALCOHOL WITHDRAWAL; ALCOHOLISM; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; ATTENTION DISTURBANCE; CLINICAL GLOBAL IMPRESSION SCALE; CONTROLLED STUDY; DECREASED APPETITE; DISORIENTATION; DIZZINESS; DOUBLE BLIND PROCEDURE; DRINKING BEHAVIOR; DRUG EFFICACY; DRUG OVERDOSE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FALLING; FATIGUE; FEMALE; GAMMA GLUTAMYL TRANSFERASE BLOOD LEVEL; HEADACHE; HEART ATRIUM FIBRILLATION; HUMAN; INSOMNIA; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NAUSEA; PARALLEL DESIGN; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; SIDE EFFECT; SOMNOLENCE; SUICIDAL BEHAVIOR; SUICIDE; UNSPECIFIED SIDE EFFECT; VOMITING; ANALOGS AND DERIVATIVES; MIDDLE AGED; YOUNG ADULT;

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

EID: 84901713176     PISSN: 02698811     EISSN: 14617285     Source Type: Journal    
DOI: 10.1177/0269881114527362     Document Type: Article

References (41)

1. Adamson SJ, Heather N, Morton V, et al. Initial preference for drinking goal in the treatment of alcohol problems: II. Treatment outcomes. Alcohol Alcohol. 2010 ; 45: 136-142
2. Alonso J, Angermeyer MC, Bernert S, 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. 2004 ; 420: S47-54
3. Diagnostic and Statistical Manual of Mental Disorders. Fourth Edition, Text Revision (DSM-IV-TR). Washington DC: APA ; 2000 :
4. 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
5. Anton RF, Pettinati H, Zweben A, et al. A multi-site dose ranging study of nalmefene in the treatment of alcohol dependence. J Clin Psychopharmacol. 2004 ; 24: 421-428
6. Beich A, Thorsen T, Rollnick S. Screening in brief intervention trials targeting excessive drinkers in general practice: Systematic review and meta-analysis. Brit Med J. 2003 ; 327: 536-542
7. Epstein EE, Drapkin ML, Yusko DA, et al. Is alcohol assessment therapeutic? Pre-treatment change in drinking among alcohol-dependent women. J Stud Alcohol. 2005 ; 66: 369-378
8. European Medicines Agency (EMA) (2010) Guideline on the development of medicinal products for the treatment of alcohol dependence. Report no. EMEA/CHMP/EWP/20097/2008. Available at: www.ema.europa.eu/docs/en-GB/document- library/Scientific-guideline/2010/03/WC500074898.pdf (accessed 3 October 2013).
9. European Medicines Agency (EMA) (2013) Find medicine - Selincro. Available at: www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/ medicines/002583/human-med-001620.jsp&mid=WC0b01ac058001d124 (accessed 3 October 2013).
10. Gastfriend DR, Garbutt JC, Pettinati HM, et al. Reduction in heavy drinking as a treatment outcome in alcohol dependence. J Subst Abuse Treat. 2007 ; 33: 71-80
11. Gual A, He Y, Torup L, et al. A randomised, double-blind, placebo controlled, efficacy study of nalmefene, as-needed use, in patients with alcohol dependence. Eur Neuropsychopharmacol. 2013 ; 23: 1432-1442
12. ECDEU assessment manual for psychopharmacology. Guy W, ed. Rockville, MD: US National Institute of Mental Health ; 1976 :
13. Heather N, Adamson SJ, Raistrick D, et al. 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
14. Karhuvaara S, Simojoki K, Virta A, 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. Kessler RC, Nelson CB, McGonagle KA, et al. The epidemiology of co-occurring addictive and mental disorders: Implications for prevention and service utilization. Am J Orthopsychiatry. 1996 ; 66: 17-31
16. Keyes KM, Hatzenbuehler ML, McLaughlin KA, et al. Stigma and treatment for alcohol disorders in the United States. Am J Epidemiol. 2010 ; 172: 1364-1372
17. Klingemann H, Rosenberg H. Acceptance and therapeutic practice of controlled drinking as an outcome goal by Swiss alcohol treatment programmes. Eur Addict Res. 2009 ; 15: 121-127
18. Kohn R, Saxena S, Levav I, et al. The treatment gap in mental health care. Bull World Health Organ. 2004 ; 82: 858-866
19. Lecrubier Y, Sheehan DV, Weiller E, 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 RZ, Fertig JB, Falk DE, 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. Luquiens A, Reynaud M, Aubin HJ. Is controlled drinking an acceptable goal in the treatment of alcohol dependence? A survey of French alcohol specialists. Alcohol Alcohol. 2011 ; 46: 586-591
22. McNair DM, Lorr M, Droppleman LF Profile of Mood States Manual. San Diego: Educational and Industrial Testing ; 1971 :
23. Mann K, Bladström A, Torup L, et al. Extending the treatment options in alcohol dependence: A randomized controlled study of as-needed nalmefene. Biol Psychiatry. 2013 ; 73: 706-713
24. 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
25. Marlatt GA, Witkiewitz K. Harm reduction approaches to alcohol use: Health promotion, prevention and treatment. Addict Behav. 2002 ; 27: 867-886
26. Mason BJ, Ritvo EC, Morgan RO, 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 BJ, Salvato FR, Williams LD, et al. A double-blind, placebo-controlled study of oral nalmefene for alcohol dependence. Arch Gen Psychiatry. 1999 ; 56: 719-724
28. Merkx MJ, Schippers GM, Koeter MW, et al. Guidelines for allocating outpatient alcohol abusers to levels of care: Predictive validity. Addict Behav. 2011 ; 36: 570-575
29. Miller WR, Tonigan JS, Longabaugh R The drinker inventory of consequences (DrInC): An instrument for assessing adverse consequences of alcohol abuse. Rockville, MD: US National Institute on Alcohol Abuse and Alcoholism ; 1995 :
30. Nabitz U, Oudejans S, Van den Brink W, et al. What is the opinion of the Dutch population about their addiction treatment services?.. 2006 ; 2: 100-108
31. Rosenberg H, Devine EG, Rothrock N. Acceptance of moderate drinking by alcoholism treatment services in Canada. J Stud Alcohol. 1996 ; 57: 559-562
32. Skinner HA, Horn JL Alcohol Dependence Scale: Users Guide. Toronto: Addiction Research Foundation ; 1984 :
33. Sobell LC, Sobell MB Measuring Alcohol Consumption: Psychosocial and Biological Method. Litten RZ Allen JP, ed. Totowa, NJ: Humana Press ; 1992 :
34. Starosta AN, Leeman RF, Volpicelli JR. The BRENDA Model: Integrating psychosocial treatment and pharmacotherapy for the treatment of alcohol use disorders. J Psychiatr Pract. 2006 ; 12: 80-89
35. Sullivan JT, Sykora K, Schneiderman J, et al. Assessment of alcohol withdrawal: The revised Clinical Institute Withdrawal Assessment for Alcohol scale (CIWA-Ar). Br J Addict. 1989 ; 84: 1353-1357
36. van Amsterdam J, Van den Brink W. Reduced-risk drinking as a viable treatment goal in problematic alcohol use and alcohol dependence. J Psychopharmacol. 2013 ; 27: 987-997
37. van den Brink W, Aubin HJ, Bladström A, et al. Efficacy of as-needed nalmefene in alcohol-dependent patients with at least a high drinking risk level: Results from a subgroup analysis of two randomized controlled 6-month studies. Alcohol Alcohol. 2013 ; 48: 570-578
38. Volpicelli JR, Pettinati HM, McLellan AT, et al Combining Medication and Psychosocial Treatments for Addictions: The BRENDA Approach. New York: The Guilford Press ; 2001 :
39. World Health Organization (WHO) (2000) International Guide for Monitoring Alcohol Consumption and Related Harm. WHO/MSD/MSB/00.4. 2000. Available at: http://whqlibdoc.who.int/hq/2000/who-msd-msb-00.4.pdf (accessed 3 October 2013).
40. Willenbring ML, Massey SH, Gardner MB. Helping patients who drink too much: An evidence-based guide for primary care clinicians. Am Fam Physician. 2009 ; 80: 44-50
41. Wittchen HU, Jacobi F, Rehm J, et al. The size and burden of mental disorders and other disorders of the brain in Europe 2010. Eur Neuropsychopharmacol. 2011 ; 21: 655-679