Document Detail


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.
MedLine Citation:
PMID:  23536105     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
IMPORTANCE: 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.
DESIGN AND SETTING: Placebo-controlled randomized clinical trial at a university medical center.
PARTICIPANTS: In total, 294 community volunteers who wanted to quit smoking.
INTERVENTIONS: Twelve weeks of varenicline, bupropion SR, or placebo plus intensive smoking cessation counseling (10 sessions, for a total of approximately 240 minutes of counseling).
MAIN OUTCOME MEASURES: 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 AND RELEVANCE: 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.
TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00507728.
Authors:
Paul M Cinciripini; Jason D Robinson; Maher Karam-Hage; Jennifer A Minnix; Cho Lam; Francesco Versace; Victoria L Brown; Jeffrey M Engelmann; David W Wetter
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Publication Detail:
Type:  Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  JAMA psychiatry     Volume:  70     ISSN:  2168-6238     ISO Abbreviation:  JAMA Psychiatry     Publication Date:  2013 May 
Date Detail:
Created Date:  2013-05-02     Completed Date:  2013-06-27     Revised Date:  2014-03-21    
Medline Journal Info:
Nlm Unique ID:  101589550     Medline TA:  JAMA Psychiatry     Country:  United States    
Other Details:
Languages:  eng     Pagination:  522-33     Citation Subset:  AIM; IM    
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00507728
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MeSH Terms
Descriptor/Qualifier:
Adolescent
Adult
Affect
Aged
Benzazepines / administration & dosage*,  adverse effects
Bupropion / administration & dosage*,  adverse effects
Combined Modality Therapy
Counseling / methods*
Delayed-Action Preparations / administration & dosage,  adverse effects,  pharmacology
Depression* / chemically induced,  drug therapy,  psychology
Female
Humans
Male
Middle Aged
Nicotine / adverse effects
Nicotinic Agonists / administration & dosage*,  adverse effects
Quinoxalines / administration & dosage*,  adverse effects
Smoking / drug therapy*,  psychology
Smoking Cessation* / methods,  psychology
Substance Withdrawal Syndrome* / drug therapy,  etiology,  psychology
Treatment Outcome
Young Adult
Grant Support
ID/Acronym/Agency:
DA017073/DA/NIDA NIH HHS; P30 CA016672/CA/NCI NIH HHS; P50CA70907/CA/NCI NIH HHS; R01 DA017073/DA/NIDA NIH HHS
Chemical
Reg. No./Substance:
0/Benzazepines; 0/Delayed-Action Preparations; 0/Nicotinic Agonists; 0/Quinoxalines; 01ZG3TPX31/Bupropion; 54-11-5/Nicotine; W6HS99O8ZO/varenicline
Comments/Corrections
Comment In:
Evid Based Med. 2014 Feb;19(1):23   [PMID:  23990527 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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