Cinciripini 2013.

Study characteristics
Methods	Study design: secondary analysis of RCT Country: USA Data collection period: 31 August 2006 – 27 October 2010 Registry ID: ClinicalTrials.gov: NCT00507728
Participants	Number of participants: N = 294; Number included in meta‐analysis: N = 180 Sample characteristics (at baseline): Age (mean): 44.3 years (SD 10.4); Sex (% male): 61.2% (180/294) Population category: general population; Specific population: adults who smoke Nicotine dependence: FTND 4.5 (SD 2.2); Baseline cigarettes per day: 19.7 (SD 9.4); Motivation to quit: selected by motivation to quit
Interventions	Behavioural support for smoking cessation: all people who smoke who received individual behavioural smoking cessation counselling which included active effort to prepare for quitting, self‐monitoring, identification of high‐risk situations and coping skill development Pharmacological support for smoking cessation: varenicline tartrate or placebo and bupropion hydrochloride sustained release (SR) or placebo Psychotherapeutic or psychoactive support for mental health or mood: received mood management; behavioural counselling included stress management and relaxation visualisation; some participants received bupropion (anti‐depressant)
Outcomes	Definition of cessation used: prolonged abstinence (primary smoking outcome), whereby relapse was defined as 7 or more consecutive days of smoking or smoking at least 1 cigarette over 2 consecutive weeks from the end of the grace period to a selected future time point (e.g. EOT, 3 and 6 months post‐quit date); 7‐day point‐prevalence abstinence defined as self‐report of no smoking (not even a puff), in 7 days prior to time point of interest; continuous abstinence defined as self‐report of no smoking (not even a puff) from 2‐weeks post‐quit date to future time point or last 4 weeks of treatment or week 8 of medication Cessation definition used for outcome(s) in this analysis: continuous abstinence Measure of biovalidation: expired CO < 10 ppm; salivary cotinine values < 15 ng/mL Definition of people who continued smoking used: ‘non‐abstinent’; carbon monoxide > 10 ppm; participants unavailable for assessment considered non‐abstinent Time point(s) at which follow‐up was conducted: 3‐, 4‐ and 6‐month post‐quit follow‐up visits Outcome category: Mixed Anxiety and Depression Outcome measure(s): Positive and Negative Affect Schedule (PANAS; negative affect scale)
Funding source	Support for this research was provided by grant DA017073 from the National Institute on Drug Abuse (Dr Cinciripini) and by Cancer Center Support Grant P50CA70907 from the National Cancer Institute. Varenicline was provided by Pfizer
Author conflicts of interest	Dr Cinciripini served on the scientific advisory board of Pfizer, conducted educational talks sponsored by Pfizer on smoking cessation (2006‐2008), and has received grant support from Pfizer
Notes	Outcome data source: Unpublished data