Richmond 2013.
Methods | NORTRIPTYLINE Randomized controlled trial Setting: 18 prisons, Australia Recruitment: referral from clinic staff, flyers and posters in prisons |
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Participants | 425 male prisoners aged >18, incarcerated for ≥ 1m with ≥ 6m of current sentence remaining, FTND ≥ 5. av age 34, av cpd 23, 83% FTND ≥ 6 | |
Interventions | 1. Nortriptyline in tablet form for 13 weeks (TQD week 3. Week 1: 25 mg/day for 3 days, 50 mg/day for 4 days. Weeks 2 to 12 75 mg/day. Week 13 50 mg/day for 4 days, then 25 mg/day for 3 days) 2. Placebo on same schedule Both groups: Two 30 minute counselling sessions with CBT. Self‐help materials, access to quitline. 10 weeks NRT patch started on TQD; 21 mg weeks 1‐6, 14 mg/day weeks 7‐8, 7 mg/day weeks 9‐10. |
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Outcomes | Continuous abstinence at 12m Validation: CO < 10 ppm |
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Notes | New for 2013 update N quit extrapolated from percentages provided Funding: National Health and Medical Research Council, NSW Department of Health, Queensland Department of Health. NRT provided free of charge by GlaxoSmithKline. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | “Randomization algorithm,” no further information provided |
Allocation concealment (selection bias) | Unclear risk | Not specified |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Identical placebo. “Follow‐up assessments were conducted… by a prison nurse research assistant who was blind to group allocation.” No further information on blinding provided. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 80% followed up at 12m, similar in both groups |