Lifrak 1997.
Methods | Study design: Randomized controlled trial Setting: substance abuse outpatient facility, USA Recruitment: community volunteers |
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Participants | 69 smokers av. age 39, av. cpd 25 | |
Interventions | Therapists: nurse practitioner for 1 and 2, clinical social worker or psychiatrist experienced in addiction treatment for 2. Both interventions included use of nicotine patch (24‐hr, 10 wks tapered dose) 1. Moderate intensity ‐ 4 meetings with nurse who reviewed S‐H materials and instructed in patch use 2. High intensity. As 1 plus 16 weekly 45‐min cognitive behavioural relapse‐prevention therapy |
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Outcomes | Abstinence at 12 m, 1 wk PP Validation: urine cotinine for some participants, but no corrections made for misreporting | |
Notes | Both interventions regarded as counselling, used in comparison of intensity. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Block randomization (block size 10) |
Allocation concealment (selection bias) | Unclear risk | No details given |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Some biochemical validation of abstinence, all participants had active therapy |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 12 administrative dropouts/exclusions not included, treatment group not specified. All others included |