Pacifici 2015.
| Study characteristics | ||
| Methods | Design: Uncontrolled pre‐post pilot study Recruitment: Word of mouth Setting: Hospital‐based smoking cessation clinic, Italy Study start date/end date: Not specified |
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| Participants | Total N: 34 Inclusion criteria: adults who smoke, unwilling to quit smoking tobacco cigarettes and who have never tried a quit‐smoking protocol or have refused any smoking cessation treatment, or both Exclusion criteria: none stated Inclusion based on specific population characteristic: No 47.1% women, mean age 40.6, mean cpd 21.5 no EC use at baseline, not motivated to quit |
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| Interventions |
EC: Refillable Participants were given commercially‐available EC (AVATAR device, Battery 550 mAh/3.9 V, W: 7.8, cartomizer with 2, 2 ohm resistance, tank capacity 1.5 mL, temperature of the aerosol: 55/65 degrees), 2 different chargers for each EC and PUFFIT e‐liquids with nicotine content matching the individual nicotine daily intake and tobacco and/or other flavors freely chosen by each participant W1: nicotine‐free e‐liquid W2&3: Own EC with personal nicotine dosage, encouraged to use as substitute for traditional cigarettes W4: Encouraged to forego all traditional cigarettes Throughout: assistance at any time of day from centre staff with any EC‐related problem, plus follow‐up group sessions and smartphone messaging application Behavioural support: Multi‐component medically‐assisted training programme with monitoring of nicotine intake as a biomarker of correct EC use, including Information about general working principles, safety and risks of EC, together with medically‐assisted face‐to‐face training on how to correctly use the device to absorb nicotine vapor |
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| Outcomes | Follow‐up at 1, 4 and 8 m Cessation (measure not defined) Adverse events Exhaled CO, COT, 3‐HCOT concentration cpd |
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| Study funding | The authors thank Renata Solimini, Adele Minutillo, Emilia Marchei and Maria Concetta Rotolo for their technical assistance. This work was supported by the Department of Therapeutic Research and Medicines Evaluation Istituto Superiore di Sanità, Roma, Italy | |
| Author declarations | The authors declare no conflict of interest | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | High risk | Not controlled |
| Allocation concealment (selection bias) | High risk | Not controlled |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | All participants followed up |
| Selective reporting (reporting bias) | High risk | AEs measured but not reported |