Williams 2010.
Methods | Study design: Randomized controlled trial Setting: Mental health outpatient clinics, USA Recruitment: People with schizophrenia or schizoaffective disorder, willing to use NRT |
|
Participants | 100 smokers (> 10 cpd) using an atypical antipsychotic; 16% women, av. age ˜46, av. cpd 23 | |
Interventions | Therapists: trained mental health clinicians provided both conditions Pharmacotherapy: nicotine patch (21 mg for 16 wks incl tapering) 1. Treatment of Addiction to Nicotine in Schizophrenia (TANS); 24 x 45‐min individual counselling sessions over 26 wks 2. Medical Management (MM); 9 x 20 mins over 26 wks |
|
Outcomes | Continuous abstinence at 12 m Validation: CO < 10 ppm |
|
Notes | New for 2016 update Contributes to comparison 2.1.2, more versus less intensive counselling as adjunct to pharmacotherapy |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "adaptive urn randomization procedure that accounts for motivation, gender, ethnicity, and heavy versus light smoking status" |
Allocation concealment (selection bias) | Low risk | Judged that process for randomization prevented prior knowledge of condition |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Biochemical validation of abstinence |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 75% followed up at 12 m, authors report "not different between groups" |