Shoptaw 2002.
Methods | Randomised 4‐arm controlled trial Country: USA Setting: 3 narcotic treatment centres in LA |
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Participants | 175 smokers (≥ 10 CPD, expired CO > 8 ppm, cotinine > 30 ng/mL), av age 44, 39.5% women, av 22.1 CPD. No significant differences between groups, except group 3 reported higher cocaine use than other groups | |
Interventions | 2‐week baseline and randomisation period, then 12 weeks treatment with NRT patches, tapered from 21 mg for 8 weeks, to 14 mg for 2 weeks and 7 mg for 2 weeks. CO and urine samples taken x 3/week. Randomised to: Group 1. NRT patch only Group 2 NRT patch + RP Group 3. NRT patch + CM: USD 2 for 1st CO sample < 8 ppm; each consecutive sample rewarded with voucher increased by USD 0.50, + bonus USD 5 for every 3 consecutive samples. If a sample > 8 ppm, reward process reverted to USD 2 level again, but was restored to previous scale after 1 round of 3 consecutive samples < 8 ppm. Participants could earn up to USD 447.50 Group 4. NRT patch + RP + CM (see group 3 procedure) | |
Outcomes | Baseline measures, + thrice‐weekly breath and urine samples throughout 12 weeks treatment, + weekly self‐report, and same measures at 6 months and 12 months. Participants with missing data were counted as continuing smokers | |
Notes | Additional outcome data supplied by the authors Study funded by National Institute on Drug Abuse, and National Cancer Institute | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "an urn randomization procedure". A randomised 2 x 2 repeated measures design |
Allocation concealment (selection bias) | Unclear risk | Not stated |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Abstinence biochemically validated |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Group A (patch only): 6 months 5/43, 12 months 7/43 dropped out; Group B (patch + CM): 6 months 6/43, 12 months 8/43 dropped out |