Hurt 2003.
Methods | BUPROPION Randomized controlled trial Setting: multi‐centre 14 North Central Cancer Treatment Group sites, USA Recruitment: community volunteers. |
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Participants | 578 smokers recruited to first stage of study: >= 15 CPD; 57% F, av age 42, 21% history of MDD 176 smokers abstinent after 8w nicotine patch treatment randomized to relapse prevention intervention 194 non‐abstinent smokers randomized to bupropion as second line therapy | |
Interventions | (All participants first received nicotine patch for 8w, dose based on cig consumption) Relapse prevention arm: 1. Bupropion for 26w 2. Placebo Second line therapy arm: 1. Bupropion for 8w 2. Placebo | |
Outcomes | Relapse prevention arm: Abstinence at 12m, (PP, 6m after end of therapy). Second line therapy arm: Abstinence at 6m (4m after end of therapy) Validation: CO < 8 ppm | |
Notes | Does not contribute to primary analysis.
Long‐term follow up for 2nd line Rx arm from authors. Funding: National Cancer Institute, Public Health Service. Medication provided by Glaxo Wellcome and Elan Pharmaceutical. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomized using 'dynamic allocation'. |
Allocation concealment (selection bias) | Unclear risk | Not described. |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | "Double‐blind," no further information provided |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Number of participants lost to follow‐up not given. Patients lost to follow‐up considered to be smoking. |