Killen 2010.
Methods | 8‐Week double‐blind randomized placebo‐controlled clinical trial Setting: community‐based, USA Recruitment: community recruitment through radio, newspapers, community website, and notices distributed via local organisations Study period: May 2006 to July 2008 |
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Participants | N = 243 Inclusion criteria: 18 to 65 years of age; smoked 10 or more cigarettes a day Males: 70%; average age: 45; average cigarettes/d: 19 |
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Interventions | Selegiline patch for 8 weeks, 6 mg/24 hours, starting on TQD vs identical placebo patch on same schedule Both groups received 9 sessions of individual cognitive‐behavioural therapy. |
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Outcomes |
Primary outcome: point prevalence abstinence (PPA) at week 25 and week 52 (i.e. report of non‐smoking (not even a puff) for 7 consecutive days before contact and an expired air carbon monoxide level < 10 ppm) Secondary outcomes: time to relapse; occurrence, duration, and severity of adverse events |
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Funding source | National Institute on Drug Abuse; medication and matching placebo were provided by Somerset Pharmaceuticals, Inc. | |
Declaration of interest | Dr Schatzberg served as a consultant for Somerset Pharmaceuticals. | |
Notes | Analyses of pharmacogenomics are reported in Sarginson 2015 (N = 231 with DNA samples; 77.1% Caucasian, 9.1% Hispanic, 3.9% Asian, 1.3% black, 0.4% other, and 8.2% mixed ancestry). All analyses of pharmacogenomics were performed in both the full cohort and the Caucasian‐only cohort. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Use of random number generator |
Allocation concealment (selection bias) | Low risk | Participants were assigned sequential ID numbers corresponding to drugs used. Also: “The drug (active or placebo) associated with each ID was pre‐packaged and labelled by ID only at an off‐site location by an individual who had no association with the participants.” |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | “Treatment assignment was concealed from staff and both research staff and participants were blind to week 52.” |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | “Treatment assignment was concealed from staff and both research staff and participants were blind to week 52.” |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Follow‐up at 12 months: 87% (same in both arms) |
Selective reporting (reporting bias) | Low risk | Registered in clinicaltrials.gov under NCT01330030; no deviation from prespecified outcomes |
Other bias | Low risk | 12 people did not provide DNA for analyses of pharmacogenomics; use of PCA was included in analyses of pharmacogenomics. |