Covey 2002.
Methods | SERTRALINE Randomized controlled trial Setting: clinic, USA Recruitment: volunteers |
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Participants | 134 smokers with a history of past MDD; 65% F, av age 44.5, 47% had history of recurrent MDD | |
Interventions | 1. Sertraline starting dose 50 mg/day, 200 mg/day by week 4 quit day. 9 day taper. Total duration 10w + 9 day taper, including 1w placebo washout prior to randomization 2. Placebo Both arms: 9 x 45 min individual counselling sessions at clinic visits | |
Outcomes | Abstinence 6m after end of treatment (7 day PP) Validation: serum cotinine < 25 ng/ml | |
Notes | Funding: Pfizer, Inc and National Institute on Drug Abuse | |
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 specified |
Blinding (performance bias and detection bias) All outcomes | Low risk | "double‐blind" "Medications were provided in prepared bottles that were numbered according to the randomization schedule and dispensed at each visit. All study staff at the clinic site were blinded to treatment assignment." |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Total participants lost to follow‐up at 6m not reported. "The subjects lost to follow‐up after random assignment were considered treatment failures." |