Prochazka 1998.
Methods | NORTRIPTYLINE Randomized controlled trial Setting: VAMC & Army Medical Centre, USA Recruitment: outpatient clinics and campus advertisements |
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Participants | 214 smokers, >10 CPD (Excludes 29 early drop‐outs); 38% F, av age 47, av CPD 21,12% had a history of depression | |
Interventions | 1. Nortriptyline max 75 mg/day from 10 days pre‐quit date to 8w after, tapered for 2w. 2. Placebo capsules. Both arms: 2 behavioural group sessions prior to drug therapy. During treatment individual support was provided by the study nurse. | |
Outcomes | Abstinence at 6m (prolonged) Validation: CO =< 9 ppm at each visit and urine cotinine < 50 ng/mL at 6m. | |
Notes | Funding: Department of Veterans Affairs, US Department of Defense | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomization method not described. |
Allocation concealment (selection bias) | Unclear risk | Not described |
Blinding (performance bias and detection bias) All outcomes | High risk | "An unblinded research pharmacist recommended dosage reductions for those above the therapeutic range and dosage increases for those who were subtherapeutic. To maintain blinding, dose reductions and increases on an equal number of randomly selected placebo‐treated subjects were also recommended...our blinding was only partially effective. Because of the high frequency of dry mouth, the nurse and subjects were often able to identify the active drug." |
Incomplete outcome data (attrition bias) All outcomes | High risk | 75% drop‐out rate in placebo, 61% in drug group, majority classified as ineffective therapy. |