Eisenhofer 2015.
Study characteristics | ||
Methods | Design: RCT Setting: USA |
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Participants | 11 EC = 4; NRT = 7 Veterans who meet DSM criteria for tobacco use disorder 18% female. Mean age 52.6. Mean cpd 26.4. Mean ftnd 7.5. 64% African American |
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Interventions | EC type: cartridge Arm 1: Electronic cigarettes 16 mg cartridge. Arm 2: NRT. Participants attended thrice‐weekly visits during the first 2 weeks (week 1‐“baseline” with participants smoking ad libitum) and attended five visits during the third week (week 3‐“efficacy” with participants smoking as little as possible while using NRT or E‐cigs) |
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Outcomes | Self‐reports of cigarettes smoked in last 24 hours, confirmed by breath CO levels and salivary cotinine | |
Study funding | This work was conducted at and supported by resources at the MEDVAMC, including a MEDVAMC Research Enhancement Seed Grant | |
Author declarations | NS | |
Notes | New for Sept 2021 update Study information extracted from conference abstract only |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: “Veterans were randomized to either NRT (16mg patch;N=7) or E‐cigs (16mgcartridge;N=4).” No further information provided |
Allocation concealment (selection bias) | Unclear risk | No information provided |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | No blinding but active interventions provided to both arms |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "CO levels and salivary cotinine were recorded during each visit.' 'Self‐reports of cigarettes smoked in last 24 h, and this was confirmed by significant reductions of breath CO levels by NRT (t = 3.7, p = .01) and E‐Cigs (t = 3.9, p = .03)." |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No information provided |
Selective reporting (reporting bias) | Unclear risk | No protocol or clinical trial record available to determine whether all prespecified outcomes are reported |