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

Lechner 2019.

Study characteristics
Methods Study design: secondary analysis of RCT
Country: USA
Data collection period: not stated
Registry ID: not reported
Participants Number of participants: N = 150; Number included in meta‐analysis: N = 37
Sample characteristics (at baseline):
Age (mean): 42.1 years (SD 12.7); Sex (% male): 58.7% (88/150)
Population category: general population; Specific population: people who were drinking heavily and smoking (at least once per month on average (≥ 4 drinks per occasion for women; ≥ 5 drinks for men)) recruited from the community
Nicotine dependence: FTCD 5.3 (SD 2.3); Baseline cigarettes per day: 17.9 (SD 9.5); Motivation to quit: selected by motivation to quit
Interventions Behavioural support for smoking cessation: participants received 6‐sessions of counselling that addressed heavy drinking and smoking. The Counseling and Medication Management (CMM) intervention provided (i) smoking cessation treatment consistent with clinical practice guidelines, (ii) counselling on alcohol and its impact on smoking cessation, and (iii) monitoring of oral study medication use and safety following guidelines in medical management – in addition to standard smoking cessation modules, session 1 included normative feedback on drinking and discussion of goals related to short‐ and long‐term changes in drinking. subsequent sessions focused on study medication use, side effects, progress in quitting smoking, provision of support, review of current drinking, efforts to modify drinking, and problem‐solving for high‐risk situations for smoking relapse; a quit date was set in the second week of the 10‐week treatment
Pharmacological support for smoking cessation: participants received 6 weeks of transdermal nicotine patches; participants were drawn from a parent study in which they were randomised to receive 10 weeks of either i) 50 mg naltrexone (n = 75), or ii) placebo (n = 75) daily
Psychotherapeutic or psychoactive support for mental health or mood: did not receive mood management
Outcomes Definition of cessation used: 7‐day point‐prevalence smoking abstinence was assessed at 2, 8, 16, and 26 weeks after quit date and was bioverified
Cessation definition used for outcome(s) in this analysis: point‐prevalence abstinence
Measure of biovalidation: expired CO ( ≤ 4 ppm)
Definition of people who continued to smoke used: exact definition not reported; ‘no significant change in use relevant to baseline’
Time point(s) at which follow‐up was conducted: 2, 8, 16, and 26 weeks after quit date
Outcome category: Depression
Outcome measure(s): Center for Epidemiologic Studies Depression Scale (CES‐D)
Funding source This study was supported by NIHNIAAA R01‐ AA01718 (Kahler)
Author conflicts of interest No conflict declared
Notes Outcome data source: Published data