title: Effects of varenicline and bupropion sustained-release use plus intensive smoking cessation counseling on prolonged abstinence from smoking and on depression, negative affect, and other symptoms of nicotine withdrawal.
abstract: OBJECTIVE
  Given the actions of varenicline tartrate and bupropion hydrochloride sustained-release (SR) on neurobiological targets related to affect and reward, it is thought that the modulation of nicotine withdrawal symptoms may contribute to their effectiveness.
  
  
  OBJECTIVE
  To assess the relative efficacy of varenicline and bupropion SR plus intensive counseling on smoking cessation and emotional functioning.
  
  
  METHODS
  Placebo-controlled randomized clinical trial at a university medical center.
  
  
  METHODS
  In total, 294 community volunteers who wanted to quit smoking.
  
  
  METHODS
  Twelve weeks of varenicline, bupropion SR, or placebo plus intensive smoking cessation counseling (10 sessions, for a total of approximately 240 minutes of counseling).
  
  
  METHODS
  Prolonged abstinence from smoking and weekly measures of depression, negative affect, and other symptoms of nicotine withdrawal.
  
  
  RESULTS
  Significant differences were found in abstinence at the end of treatment and through the 3-month postquit follow-up visit, favoring both active medications compared with placebo. At the 6-month postquit follow-up visit, only the varenicline vs placebo comparison remained significant. Varenicline use was also associated with a generalized suppression of depression and reduced smoking reward compared with the other treatments, while both active medications improved concentration, reduced craving, and decreased negative affect and sadness compared with placebo, while having little effect (increase or decrease) on anxiety and anger. No differences were noted in self-reported rates of neuropsychiatric adverse events.
  
  
  CONCLUSIONS
  In a community sample, varenicline exerts a robust and favorable effect on smoking cessation relative to placebo and may have a favorable (suppressive) effect on symptoms of depression and other affective measures, with no clear unfavorable effect on neuropsychiatric adverse events.
  
  
  BACKGROUND
  clinicaltrials.gov Identifier: NCT00507728.
authors.affiliation: Department of Behavioral Science, The University of Texas MD Anderson Cancer Center, Houston, TX 77230-1439, USA. pcinciri@mdanderson.org
authors.forename: Paul M
authors.initials: PM
authors.lastname: Cinciripini
authors.forename: Jason D
authors.initials: JD
authors.lastname: Robinson
authors.forename: Maher
authors.initials: M
authors.lastname: Karam-Hage
authors.forename: Jennifer A
authors.initials: JA
authors.lastname: Minnix
authors.forename: Cho
authors.initials: C
authors.lastname: Lam
authors.forename: Francesco
authors.initials: F
authors.lastname: Versace
authors.forename: Victoria L
authors.initials: VL
authors.lastname: Brown
authors.forename: Jeffrey M
authors.initials: JM
authors.lastname: Engelmann
authors.forename: David W
authors.initials: DW
authors.lastname: Wetter
mesh_terms: D000293:Adolescent; D000328:Adult; D000339:Affect; D000368:Aged; D001552:Benzazepines / Q000008:administration & dosage* / Q000009:adverse effects; D016642:Bupropion / Q000008:administration & dosage* / Q000009:adverse effects; D003131:Combined Modality Therapy; D003376:Counseling / Q000379:methods*; D003692:Delayed-Action Preparations / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology; D003863:Depression / Q000139:chemically induced / Q000188:drug therapy / Q000523:psychology; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009538:Nicotine / Q000009:adverse effects; D018722:Nicotinic Agonists / Q000008:administration & dosage* / Q000009:adverse effects; D011810:Quinoxalines / Q000008:administration & dosage* / Q000009:adverse effects; D012907:Smoking / Q000188:drug therapy* / Q000523:psychology; D016540:Smoking Cessation / Q000379:methods / Q000523:psychology; D013375:Substance Withdrawal Syndrome / Q000188:drug therapy / Q000209:etiology / Q000523:psychology; D016896:Treatment Outcome; D000068580:Varenicline; D055815:Young Adult
chemical_list: D001552:Benzazepines; D003692:Delayed-Action Preparations; D018722:Nicotinic Agonists; D011810:Quinoxalines; D016642:Bupropion; D009538:Nicotine; D000068580:Varenicline
references.citation: Mol Pharmacol. 2004 Sep;66(3):675-82
references.pmid: 15322260
references.citation: Am J Epidemiol. 1984 Jun;119(6):997-1004
references.pmid: 6731436
references.citation: Nicotine Tob Res. 2012 Mar;14(3):343-50
references.pmid: 22080588
references.citation: J Consult Clin Psychol. 1996 Aug;64(4):791-8
references.pmid: 8803370
references.citation: Psychopharmacol Bull. 1988;24(3):438-43
references.pmid: 3153505
references.citation: BMC Public Health. 2006 Dec 11;6:300
references.pmid: 17156479
references.citation: J Clin Psychiatry. 1995 Sep;56(9):395-401
references.pmid: 7665537
references.citation: Exp Clin Psychopharmacol. 1999 Nov;7(4):354-61
references.pmid: 10609970
references.citation: JAMA. 2006 Jul 5;296(1):47-55
references.pmid: 16820546
references.citation: Nicotine Tob Res. 2003 Feb;5(1):13-25
references.pmid: 12745503
references.citation: J Clin Psychiatry. 1998;59 Suppl 20:22-33;quiz 34-57
references.pmid: 9881538
references.citation: Addict Behav. 2007 May;32(5):912-23
references.pmid: 16875787
references.citation: Psychopharmacology (Berl). 2008 Apr;197(3):371-7
references.pmid: 18084743
references.citation: MMWR Morb Mortal Wkly Rep. 2011 Nov 11;60(44):1513-9
references.pmid: 22071589
references.citation: Arch Gen Psychiatry. 1986 Mar;43(3):289-94
references.pmid: 3954551
references.citation: J Pers Soc Psychol. 1988 Jun;54(6):1063-70
references.pmid: 3397865
references.citation: J Med Chem. 2005 May 19;48(10):3474-7
references.pmid: 15887955
references.citation: J Behav Med. 1982 Sep;5(3):343-51
references.pmid: 7131548
references.citation: CMAJ. 2011 Sep 6;183(12):1359-66
references.pmid: 21727225
references.citation: Br J Addict. 1991 Sep;86(9):1119-27
references.pmid: 1932883
references.citation: Am J Health Behav. 2008 Nov-Dec;32(6):664-75
references.pmid: 18442345
references.citation: PLoS One. 2011;6(11):e27016
references.pmid: 22073240
references.citation: Arch Gen Psychiatry. 1993 Sep;50(9):739-50
references.pmid: 8357299
references.citation: JAMA. 2006 Jul 5;296(1):56-63
references.pmid: 16820547
references.citation: Pediatrics. 2003 Jun;111(6 Pt 1):1318-23
references.pmid: 12777547
references.citation: J Clin Psychiatry. 2012 May;73(5):654-60
references.pmid: 22697191
references.citation: Cochrane Database Syst Rev. 2007 Jan 24;(1):CD000031
references.pmid: 17253443