PMID- 37069490
OWN - NLM
STAT- MEDLINE
DCOM- 20230808
LR  - 20230824
IS  - 1360-0443 (Electronic)
IS  - 0965-2140 (Linking)
VI  - 118
IP  - 9
DP  - 2023 Sep
TI  - Efficacy and safety of combination behavioral activation for smoking cessation 
      and varenicline for treating tobacco dependence among individuals with current or 
      past major depressive disorder: A 2 x 2 factorial, randomized, placebo-controlled 
      trial.
PG  - 1710-1725
LID - 10.1111/add.16209 [doi]
AB  - BACKGROUND AND AIMS: Treatment of depression-related psychological factors 
      related to smoking behavior may improve rates of cessation among adults with 
      major depressive disorder (MDD). This study measured the efficacy and safety of 
      12 weeks of behavioral activation for smoking cessation (BASC), varenicline and 
      their combination. DESIGN, SETTING, PARTICIPANTS: This study used a randomized, 
      placebo-controlled, 2 x 2 factorial design comparing BASC versus standard 
      behavioral treatment (ST) and varenicline versus placebo, taking place in 
      research clinics at two urban universities in the United States. Participants 
      comprised 300 hundred adult smokers with current or past MDD. INTERVENTIONS: BASC 
      integrated behavioral activation therapy and ST to increase engagement in 
      rewarding activities by reducing avoidance, withdrawal and inactivity associated 
      with depression. ST was based on the 2008 PHS Clinical Practice Guideline. Both 
      treatments consisted of eight 45-min sessions delivered between weeks 1 and 12. 
      Varenicline and placebo were administered for 12 weeks between weeks 2 and 14. 
      MEASUREMENTS: Primary outcomes were bioverified intent-to-treat (ITT) 7-day 
      point-prevalence abstinence at 27 weeks and adverse events (AEs). FINDINGS: No 
      significant interaction was detected between behavioral treatment and 
      pharmacotherapy at 27 weeks (chi(2) ((1))  = 0.19, P = 0.67). BASC and ST did not 
      differ (chi(2) ((1))  = 0.43, P = 0.51). Significant differences in ITT abstinence 
      rates (chi(2) ((1))  = 4.84, P = 0.03) emerged among pharmacotherapy arms (16.2% 
      for varenicline, 7.5% for placebo), with results favoring varenicline over 
      placebo (rate ratio = 2.16, 95% confidence interval = 1.08, 4.30). All 
      significant differences in AE rates after start of medication were higher for 
      placebo than varenicline. CONCLUSION: A randomized trial in smokers with major 
      depressive disorder found that varenicline improved smoking abstinence versus 
      placebo at 27 weeks without elevating rates of adverse events. Behavioral 
      activation for smoking cessation did not outperform standard behavioral 
      treatment, with or without adjunctive varenicline therapy.
CI  - (c) 2023 The Authors. Addiction published by John Wiley & Sons Ltd on behalf of 
      Society for the Study of Addiction.
FAU - Hitsman, Brian
AU  - Hitsman B
AUID- ORCID: 0000-0003-2346-4521
AD  - Department of Preventive Medicine, Northwestern University Feinberg School of 
      Medicine, Chicago, Illinois, United States.
AD  - Robert H. Lurie Comprehensive Cancer Center of Northwestern University, United 
      States.
AD  - Department of Psychiatry and Behavioral Sciences, Northwestern University 
      Feinberg School of Medicine, United States.
FAU - Papandonatos, George D
AU  - Papandonatos GD
AD  - Department of Biostatistics and Center for Statistical Sciences, Brown University 
      School of Public Health, Providence, Rhode Island, United States.
FAU - Gollan, Jacqueline K
AU  - Gollan JK
AD  - Department of Psychiatry and Behavioral Sciences, Northwestern University 
      Feinberg School of Medicine, United States.
AD  - Asher Center for the Study and Treatment of Depressive Disorders, Chicago, 
      Illinois, United States.
FAU - Huffman, Mark D
AU  - Huffman MD
AD  - Department of Preventive Medicine, Northwestern University Feinberg School of 
      Medicine, Chicago, Illinois, United States.
AD  - John T. Milliken Department of Medicine, Washington University School of 
      Medicine, Washington University in St. Louis, St. Louis, Missouri, United States.
AD  - Cardiovascular Program, The George Institute for Global Health, University of 
      South Wales, Newtown, New South Wales, Australia.
FAU - Niaura, Raymond
AU  - Niaura R
AD  - Department of Epidemiology, School of Global Public Health, New York University, 
      New York, New York, United States.
FAU - Mohr, David C
AU  - Mohr DC
AD  - Robert H. Lurie Comprehensive Cancer Center of Northwestern University, United 
      States.
AD  - Department of Psychiatry and Behavioral Sciences, Northwestern University 
      Feinberg School of Medicine, United States.
FAU - Veluz-Wilkins, Anna K
AU  - Veluz-Wilkins AK
AD  - Department of Preventive Medicine, Northwestern University Feinberg School of 
      Medicine, Chicago, Illinois, United States.
FAU - Lubitz, Su Fen
AU  - Lubitz SF
AD  - Department of Psychiatry, University of Pennsylvania Perelman School of Medicine, 
      Philadelphia, Pennsylvania, United States.
FAU - Hole, Anita
AU  - Hole A
AD  - Department of Psychiatry, University of Pennsylvania Perelman School of Medicine, 
      Philadelphia, Pennsylvania, United States.
FAU - Leone, Frank T
AU  - Leone FT
AD  - Department of Medicine, University of Pennsylvania Perelman School of Medicine, 
      Perelman Center for Advanced Medicine, Philadelphia, Pennsylvania, United States.
FAU - Khan, Sadiya S
AU  - Khan SS
AD  - Department of Preventive Medicine, Northwestern University Feinberg School of 
      Medicine, Chicago, Illinois, United States.
FAU - Fox, Erica N
AU  - Fox EN
AD  - Department of Preventive Medicine, Northwestern University Feinberg School of 
      Medicine, Chicago, Illinois, United States.
FAU - Bauer, Anna-Marika
AU  - Bauer AM
AD  - Department of Psychiatry, University of Pennsylvania Perelman School of Medicine, 
      Philadelphia, Pennsylvania, United States.
FAU - Wileyto, E Paul
AU  - Wileyto EP
AD  - Department of Psychiatry, University of Pennsylvania Perelman School of Medicine, 
      Philadelphia, Pennsylvania, United States.
FAU - Bastian, Joseph
AU  - Bastian J
AD  - Department of Psychiatry, University of Pennsylvania Perelman School of Medicine, 
      Philadelphia, Pennsylvania, United States.
FAU - Schnoll, Robert A
AU  - Schnoll RA
AUID- ORCID: 0000-0002-4089-856X
AD  - Department of Psychiatry, University of Pennsylvania Perelman School of Medicine, 
      Philadelphia, Pennsylvania, United States.
LA  - eng
SI  - ClinicalTrials.gov/NCT02378714
GR  - R01 CA184211/CA/NCI NIH HHS/United States
GR  - R01 CA197332/CA/NCI NIH HHS/United States
GR  - UL1 TR001422/TR/NCATS NIH HHS/United States
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, N.I.H., Extramural
PT  - Research Support, Non-U.S. Gov't
DEP - 20230503
PL  - England
TA  - Addiction
JT  - Addiction (Abingdon, England)
JID - 9304118
RN  - W6HS99O8ZO (Varenicline)
RN  - 0 (Nicotinic Agonists)
RN  - 0 (Benzazepines)
RN  - 0 (Quinoxalines)
SB  - IM
MH  - Adult
MH  - Humans
MH  - Varenicline/therapeutic use
MH  - *Tobacco Use Disorder/drug therapy
MH  - *Smoking Cessation/methods
MH  - *Depressive Disorder, Major/drug therapy
MH  - Nicotinic Agonists/therapeutic use
MH  - Benzazepines/therapeutic use
MH  - Treatment Outcome
MH  - Quinoxalines/therapeutic use
OTO - NOTNLM
OT  - adults
OT  - behavioral activation therapy
OT  - major depressive disorder
OT  - smoking cessation treatment
OT  - tobacco dependence
OT  - varenicline
EDAT- 2023/04/18 06:00
MHDA- 2023/08/08 06:42
CRDT- 2023/04/17 23:52
PHST- 2022/08/02 00:00 [received]
PHST- 2023/03/28 00:00 [accepted]
PHST- 2023/08/08 06:42 [medline]
PHST- 2023/04/18 06:00 [pubmed]
PHST- 2023/04/17 23:52 [entrez]
AID - 10.1111/add.16209 [doi]
PST - ppublish
SO  - Addiction. 2023 Sep;118(9):1710-1725. doi: 10.1111/add.16209. Epub 2023 May 3.