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. 2021 Mar 9;2021(3):CD013522. doi: 10.1002/14651858.CD013522.pub2

Schnoll 2016.

Study characteristics
Methods Study design: secondary analysis of RCT
Country: USA
Data collection period: June 2009 – April 2014
Registry ID: ClinicalTrials.gov: NCT01047527
Participants Number of participants: N = 180; Number included in meta‐analysis: N = 180
Sample characteristics (at baseline):
Age (mean): 45.9 years (SD 12.3); Sex (% male): 50% (90/180)
Population category: general population; Specific population: people who smoked taking part in a RCT of standard (8 weeks), extended (24 weeks), or maintenance (52 weeks) transdermal nicotine therapy
Nicotine dependence: FTND: 5.3 (SD 1.9); Baseline cigarettes per day: 16.9 (SD 8.4); Motivation to quit: selected by motivation to quit
Interventions Behavioural support for smoking cessation: all participants received brief counselling (8 sessions) based on established treatment guidelines and focused on preparing for cessation, managing urges and triggers to smoking, and developing strategies to avoid relapse
Pharmacological support for smoking cessation: participants randomised to standard (8 weeks), extended (24 weeks), or maintenance (52 weeks) transdermal nicotine therapy (21 mg); for the current study, only participants randomised to 8 weeks of treatment were included in order to standardise nicotine patch treatment duration
Psychotherapeutic or psychoactive support for mental health or mood: did not receive mood management.
Outcomes Definition of cessation used: point‐prevalence abstinence at 6 months ‐ self‐reported abstinence from smoking for 7 days prior to the assessment and biochemically confirmed with breath carbon monoxide
Cessation definition used for outcome(s) in this analysis: point‐prevalence abstinence
Measure of biovalidation: expired CO (≤ 10 ppm)
Definition of people who continued to smoke used: exact definition not reported; participants who withdrew from the study, failed to provide a CO sample, or had a CO greater than 10 ppm were considered continuing to smoke
Time point(s) at which follow‐up was conducted: week 8 and 6 months
Outcome category: Anxiety, Depression
Outcome measure(s): Beck Anxiety Inventory (BAI); Inventory of Depressive Symptomology (IDS)
Funding source This research was supported by grants from the National Institute on Drug Abuse (R01DA025078 and R01DA033681) and from the National Cancer Institute (R01CA165001 and P50CA143187)
Author conflicts of interest Dr.Schnoll and Dr. Hitsman receive medication and placebo free of charge from Pfizer and have provided consultation to Pfizer; Dr.Schnoll has also consulted with GlaxoSmithKline; these companies had no involvement in this study
Notes Outcome data source: Published data