Dennis 2016.
| Study characteristics | ||
| Methods | Study design: parallel RCT Country: USA Recruitment: from outpatient clinic referrals, and by flyers and letters advertising a study on PTSD and smoking cessation posted in local hospitals |
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| Participants | 63 smokers: diagnosed with PTSD, aged 18 to 70 years, cigarettes per day ≥ 10, willing to quit within the following 30 days 46% men; average age 42; average cigarettes per day: 17.7; mean FTND: 4.1 |
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| Interventions | 1) 2 weeks of nicotine patch (preloading) treatment pre‐quit date, followed by 6 weeks of nicotine patch and nicotine gum/lozenge from quit date 2) 2 weeks of placebo patch pre‐quit date, followed by 6 weeks of nicotine patch and nicotine gum/lozenge from quit date Initial patch dose 21 mg/24‐hour – unclear if tapered down and if so at what dose |
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| Outcomes | 30‐day PPA at 6‐month follow‐up Validation: salivary cotinine (< 10 ng/mL) Adverse events: not measured |
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| Notes | Participants were compensated up to USD 650 for complete participation The study was funded by the National Institutes of Health (R21CA128965; R01CA037220; R34DA038272), by the Department of Veterans Affairs (VA) Office of Research and Development (ORD) Health Services Research and Development Service (HSR&D; I01HX000132; I01HX001109), and by the VA Mid‐Atlantic Mental Illness Research, Education, and Clinical Center Conflicts of interest: none to declare |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | No detail on exactly how participants were randomised Quote: "randomisation to active nicotine patch or placebo patch was stratified by gender and presence of current MDD [major depressive disorder]". |
| Allocation concealment (selection bias) | Low risk | Quote: "patch allocation was concealed by maintaining a list through the pharmacy that was unavailable to study investigators and coordinators" |
| Blinding (performance bias and detection bias) All outcomes | Unclear risk | Quote: “Participants were randomized…in a double blind fashion.” No detail is given on who was blinded and how exactly this occurred, but the control group received placebo patch rather than no patch |
| Incomplete outcome data (attrition bias) All outcomes | High risk | > 50% participants lost to follow‐up (18/32 in active patch group; 19/31 in placebo patch group), although similar dropout in each group |