Smith 2009.
| Study characteristics | ||
| Methods | Study design: parallel RCT Country: USA Recruitment: primary care (12 clinics) |
|
| Participants | 1346 smokers of > 10 cigarettes per day for past 6 months 44% men, average age 44, average cigarettes per day 20.3, motivated to quit |
|
| Interventions | 1) Bupropion only (up‐titrated during week pre‐quitting, 150 mg twice a day for 8 weeks post‐quit) 2) Nicotine lozenge only (4 mg lozenge if first cigarette of day smoked > 30 minutes after waking, 2 mg otherwise. 1 lozenge every 1 to 2 hours post‐quit weeks 1 to 6; 1 lozenge every 2 to 4 hours weeks 7 to 9; 1 lozenge every 4 to 8 hrs weeks 10 to 12) 3) Nicotine patch only (21 mg post‐quit weeks 1 to 4; 14 mg weeks 5 to 6; 7 mg weeks 7 to 8) 4) Bupropion and lozenge (dosage as above) 5) Patch and lozenge (dosage as above) |
|
| Outcomes | 7‐day PPA at 6 months and number of days to relapse Validation: none Adverse events: not measured |
|
| Notes | Analyses completed on ITT basis This study was supported by National Institutes of Health grant 5P50DA019706 (Dr Baker) from the National Institute on Drug Abuse and grant 1K05CA139871 (Dr Baker) from the National Cancer Institute. Dr Piper was supported by an Institutional Clinical and Translational Science Award (UW‐Madison; KL2 grant 1KL2RR025012‐01). Medication was provided to patients at no cost under a research agreement with GlaxoSmithKline. Conflicts of interest: "Dr Smith has received research support from Elan Corporation plc. Dr Jorenby has received research support from Pfizer Inc, SanofiSynthelabo, and Nabi Biopharmaceuticals and has received consulting fees from Nabi Biopharmaceuticals. Dr Fiore has received honoraria from Pfizer Inc and has served as an investigator on research studies at the University of Wisconsin that were funded by Pfizer Inc, SanofiSynthelabo, and Nabi Biopharmaceuticals. In 1998, the University of Wisconsin (UW) appointed Dr Fiore to a named Chair funded by an unrestricted gift to UW from Glaxo Wellcome. Dr Baker has served as an investigator on research projects sponsored by pharmaceutical companies including Sanofi‐Synthelabo, Pfizer Inc, and Nabi Biopharmaceuticals." |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "Smokers were randomized to the 5 treatment conditions within each clinic with blocking on sex and self‐identified race." |
| Allocation concealment (selection bias) | Unclear risk | Not specified |
| Blinding (performance bias and detection bias) All outcomes | High risk | Open‐label |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 158 individuals who did not pick up study medication at first point not included in analyses; 122 withdrawals and 9 deaths considered to be smoking |