Aveyard 2008.
Methods | NORTRIPTYLINE Randomized controlled trial Setting: National Health Service stop smoking clinics, UK Recruitment: People attending clinics |
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Participants | 901 smokers, ≥10/day; 46% F, av. age 43, av. CPD 21 | |
Interventions | 1. Nortriptyline 75 mg/day, for 8 w including tapering (max dose for 6w) 2. Placebo capsules All participants received free NRT and had behavioural support, the majority attending group sessions run by cessation specialists | |
Outcomes | Abstinence at 12 months (prolonged from day 15 post quit) Validation: CO at 4w, saliva cotinine (collected by post) at 6m & 12m | |
Notes | Funding: Cancer Research UK and National Institute for Health Research. Medication provided by King Pharmaceuticals. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "An independent statistician generated the randomisation schedule in Stata. We used block randomisation, with randomly ordered block sizes of two, four, and six, stratified by stop smoking adviser." |
Allocation concealment (selection bias) | Low risk | Study nurses recruited participants, and the study administrator (who had not met the participants) allocated participants in sequence against the list for each adviser. Only the administrator and the pharmacist knew the allocation. |
Blinding (performance bias and detection bias) All outcomes | Low risk | "Advisers, participants, and study staff...were blind to allocation... tablets were encapsulated, and identical powder filled capsules provided the placebos." |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 12% I, 17% C lost at 12m, included as smokers. Authors note that majority of losses were already smoking. |