Moderators of varenicline treatment effects in a double-blind, placebo-controlled trial for alcohol dependence: An exploratory analysis

Journal of Addiction Medicine

Volumn 9, Issue 4, 2015, Pages 296-303

  Falk, Daniel E ^a   Castle, I Jen P ^b   Ryan, Megan ^a   Fertig, Joanne ^a   Litten, Raye Z ^a  

^a NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM   (United States)

^b CSR INCORPORATED   (United States)

Author keywords

Alcohol dependence; Chantix; Moderator subgroup; Randomized placebo controlled clinical trial; Varenicline

Indexed keywords

GAMMA GLUTAMYLTRANSFERASE; PLACEBO; VARENICLINE; NICOTINIC AGENT;

ADULT; ALCOHOL CONSUMPTION; ALCOHOLISM; CANNABIS USE; CONTROLLED STUDY; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; EXPLORATORY RESEARCH; FEMALE; GAMMA GLUTAMYL TRANSFERASE BLOOD LEVEL; HUMAN; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; PARENTAL BEHAVIOR; PENN ALCOHOL CRAVING SCALE; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; REVIEW; SCORING SYSTEM; SCREENING TEST; SMOKING CESSATION; TREATMENT RESPONSE; UNSPECIFIED SIDE EFFECT; URINALYSIS; CLINICAL TRIAL; MIDDLE AGED; OUTCOME ASSESSMENT; RANDOMIZED CONTROLLED TRIAL; SEVERITY OF ILLNESS INDEX; SMOKING;

ADULT; ALCOHOLISM; DOUBLE-BLIND METHOD; FEMALE; HUMANS; MALE; MIDDLE AGED; NICOTINIC AGONISTS; OUTCOME ASSESSMENT (HEALTH CARE); SEVERITY OF ILLNESS INDEX; SMOKING; VARENICLINE;

EID: 84942890573     PISSN: 19320620     EISSN: 19353227     Source Type: Journal    
DOI: 10.1097/ADM.0000000000000133     Document Type: Review

References (40)

1. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition [DSM-IV]. Washington, DC: American Psychiatric Publishing, Inc, 1994.
2. Bito-Onon JJ, Simms JA, Chatterjee S, et al. Varenicline, a partial agonist at neuronal nicotinic acetylcholine receptors, reduces nicotine-induced increasesin 20% ethanol operant self-administration in Sprague-Dawley rats. Addict Biol 2011;16:440-449.
3. Bond JC, Roberts S C M, Greenfield TK, et al. Gender differences in public and private drinking contexts: a multi-level GENACIS analysis. Int J Environ Res Public Health 2010;7:2136-2160.
4. Capone C, Kahler CW, Swift RM, et al. Does family history of alcoholism moderate naltrexone's effects on alcohol use? J Stud Alcohol Drugs 2011;72:135-140.
5. Dawson DA, Grant BF, Stinson FS, et al. Recovery from DSM-IV alcohol dependence: United States, 2001-2002. Addiction 2005;100:281-292.
6. Feduccia AA, Chatterjee S, Bartlett S. Neuronal nicotinic acetylcholine receptors: neuroplastic changes underlying alcohol and nicotine addictions. Front Mol Neurosci 2012:5:1-18.
7. Flannery B, Volpicelli J, Pettinati H. Psychometric properties of the Penn Alcohol Craving Scale. Alcohol Clin Exp Res 1999;23:1289-1295.
8. Fucito LM, Park A, Gulliver SB, et al. Cigarette smoking predicts differential benefit from naltrexone for alcohol dependence. Biol Psychiatry 2012;72:832-838.
9. Fucito LM, Toll BA, Wu R, Romano DM, et al. A preliminary investigation of varenicline for heavy drinking smokers. Psychopharmacology 2011;215:655-663.
10. Gonzales D, Rennard S, Nides M, et al. Varenicline, an α4β2 nicotinic acetylcholine receptor partial agonist, vs sustained-release bupropion and placebo for smoking cessation. JAMA 2006;296(1):47-55.
11. ∗, and α7-nicotine acetylcholine receptors. Neuropharmacology 2010;58:1054-1066.
12. Greenfield SF, Pettinati HM, O'Malley S, et al. Gender differences in alcohol treatment: an analysis of outcome from the COMBINE study. Alcohol Clin Exp Res 2010;34:1803-1812.
13. Gual A, He Y, Torup L, et al. A randomized, double-blind, placebo-controlled, efficacy study of nalmefene, as-needed use, in patients with alcohol dependence. Eur Neuropsychopharmacol 2013;23:1432-1442.
14. Kaminski B, Weerts EM. The effects of varenicline on alcohol seeking and self-administration in Baboons. Alcohol Clin Exp Res 2014;38:376-383.
15. Kampman KM, Pettinati HM, Lynch KG, et al. A double-blind, placebocontrolled pilot trial of quetiapine for the treatment of type A and type B alcoholism. J Clin Psychopharmacol 2007;27:344-351.
16. Koob GF. Addiction is a reward deficit and stress surfeit disorder. Frontiers Psychiatry 2013;4:1-18.
17. Kranzler HR, Armeli S, Tennen H, et al. A double-blind, randomized trial of sertraline for alcohol dependence. J Clin Psychopharmacol 2011;31:22-30.
18. Kranzler HR, Burleson JA, Brown J, et al. Fluoxetine treatment seems to reduce the beneficial effects of cognitive-behavioral therapy in type B alcoholics. Alcohol Clin Exp Res 1996;20:1534-1541.
19. Kranzler HR, Feinn R, Armeli S, et al. Comparison of alcoholism subtypes as moderators of the response to sertraline treatment. Alcohol Clin Exp Res 2012;36:509-516.
20. Le Foll B, Pushparaj A, Pryslawsky Y, et al., Translational strategies for therapeutic development in nicotine addiction: rethinking the conventional bench to bedside approach. Prog Neuropsychopharmacol Biol Psychiatry 2014;52:86-93.
21. Litten RZ, Ryan ML, Fertig JB, et al. A double-blind, placebo-controlled trial assessing the efficacy of varenicline tartrate for alcohol dependence. J Addict Med 2013;7:277-286.
22. Mason BJ, Goodman AM, Chabac S, et al. Effect of oral acamprosate on abstinence in patients with alcohol dependence in a double-blind, placebo-controlled trial: The role of patient motivation. J Psychiatr Res 2006;40:383-393.
23. McKee SA, Harrison E L R, O'Malley SS, et al. Varenicline reduces alcohol self-administration in heavy-drinking smokers. Biol Psychiatry 2009;66:185-95.
24. Mihalak KB, Carroll FI, Luetje CW. Verenicline is ap partial agonist at α4β2 and a full agonist at α7 neuronal nicotinic receptors. Mol Pharmacol 2006;70:801-805.
25. Miller W. Form 90: A Structured Assessment Interview for Drinking and Related Behaviors (Test Manual). Bethesda, MD: National Institute on Alcohol Abuse and Alcoholism, 1996. NIH publication no. 96-4004.
26. Miller W. The Drinker Inventory of Consequences (DrInC): an instrument for assessing adverse consequences of alcohol abuse. In: Mattson M, Marshall LA, eds. NIAAA Project MATCH Monograph Series (Vol. 4). Bethesda, MD: National Institute on Alcohol Abuse and Alcoholism, 1995:1-94.
27. Mitchell JM, Teague CH, Kayser AS, et al. Varenicline decreases alcohol consumption in heavy-drinking smokers. Psychopharmacology 2012;223:299-306.
28. National Institute on Alcohol Abuse and Alcoholism. Rethinking Drinking. Bethesda, MD: National Institutes of Health, 2009. NIH publication no. 09-3770.
29. Nocente R, Vitali M, Balducci G, et al. Varenicline and neuronal nicotinic acetylcholine receptors: a new approach to the treatment of co-occurring alcohol and nicotine addiction? Am J Addict 2013;22:453-459.
30. Pettinati HM, Dundon W, Lipkin C. Gender differences in response to sertraline pharmacotherapy in type A alcohol dependence. Am J Addict 2004;13:236-247.
31. Plebani JG, Lynch KG, Rennert L, et al. Results from a pilot clinical trial of varenicline for the treatment of alcohol dependence. Drug Alcohol Depend 2013;133:754-758.
32. Rohsenow DJ, Miranda R Jr, McGeary JE, et al. Family history and antisocial traits moderate naltrexone's effects on heavy drinking in alcoholics. Exp Clin Psychopharmacol 2007;15:272-281.
33. Sheehan DV, Lecrubier Y, Sheehan KH, 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(Suppl 20):22-33; quiz 34-57.
34. Sobell L, Sobell M. Timeline follow-back: a technique for assessing self-reported alcohol consumption. In: Litten R, Allen J, eds. Measuring Alcohol Consumption: Psychosocial and Biochemical Methods. Totowa: Humana Press, 1992:41-72.
35. Steensland P, Simms JA, Holgate J, et al. Varenicline, an α4β2 nicotinic acetylcholine receptor partial agonist, selectively decreases ethanol consumption and seeking. Proc Natl Acad Sci 2007;104:12518-12523.
36. Wang R, Lagakos SW, Ware JH, et al. Statistics in medicine-reporting of subgroup analyses in clinical trials. N Engl J Med 2007;357(21):2189-2194.
37. Werner M, Rentz A, Frank L, et al. Participant consequence measures. Presented at the annual meeting of the Research Society on Alcoholism, Washington, DC, 2008.
38. Wouda JA, Riga D, De Vries W, et al. Varenicline attenuates cue-induced relapse to alcohol, but not nicotine seeking, while reducing inhibitory response control. Psychopharmacology 2011;216:267-77.
39. Wu J, Gao M, Taylor DH. Neuronal nicotinic acetylcholine receptors are important targets for alcohol reward and dependence. Acta Pharmacol Sin 2014:35(3):311-315.
40. Zweben A, Pettinati HM, Weiss RD, et al. Relationship between medication adherence and treatment outcomes: the COMBINE study. Alcohol Clin Exp Res 2008;32:1661-1669.