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. 2020 Apr 22;2020(4):CD000031. doi: 10.1002/14651858.CD000031.pub5

Hall 1998.

Study characteristics
Methods Study design: 2x2 factorial RCT
Country: USA
Setting: clinic
Recruitment: community volunteers
Participants 199 smokers, 33% had history of MDD; 55% female; average age 40; average cigarettes per day 21‐25
Interventions
  • Nortriptyline, titrated to therapeutic levels ‐ usually 75 mg/day to 100 mg/day, 12 weeks

  • Placebo


2 x 2 factorial design. Alternative psychological Rxs were 10 sessions of CBT or 5 sessions of health education control. Collapsed in this analysis
Outcomes
  • Smoking cessation: prolonged abstinence at 1 year post‐EOT. Validated by CO at weeks 12, 24, 39 and 64

  • Adverse events: measured for 6 weeks

Funding Source National Instutute on Drug Abuse and Veterans Administration
Author conflicts of interest None specified
Notes There were no significant main or intervention effects for MDD category, so these are pooled
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer randomization, after stratification on history of MDD and number of cigarettes smoked
Allocation concealment (selection bias) Low risk Allocation generated at enrolment
Blinding (performance bias and detection bias)
All outcomes Unclear risk Quote: "Medication was placebo controlled and double blind. Placebo and active drug were identical in appearance." However, no detail on who was blinded.
Incomplete outcome data (attrition bias)
All outcomes Low risk 30% did not complete treatment in placebo and 17% in active groups. Analyses with missing = smoking given