NCT05278065.
Study name | Complimentary electronic cigarettes for harm reduction among adult smokers with asthma (SWAP) |
Methods | RCT Setting & recruitment: Participants will be adults from the local community with persistent asthma symptoms who are regular combustible cigarette smokers and do not also regularly use ENDS. The study will recruit 30 non‐treatment seeking participants using flyers, advertisements, a website triaging visitors to the Center for Alcohol and Addiction Studies, and through targeted recruitment at community immunology clinic partners at Rhode Island Hospital, USA. |
Participants | Estimated enrolment 30 Inclusion criteria:
Exclusion criteria:
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Interventions | EC: 4th generation & disposable cartridges Arm 1: Electronic cigarette Participants in this experimental condition will be provided with a 4th generation EC device and disposable cartridges. Participants will be provided with EC and 5% nicotine e‐liquid cartridges for 8 weeks and encouraged at weekly assessments to use the EC any time they would normally smoke. Participants will be able to choose commercially available e‐liquid flavours (tobacco) at each weekly assessment. Arm 2: Smoking‐as‐usual Participants in this assessment‐only condition will continue smoking‐as‐usual. |
Outcomes | Baseline, week 8, week 16. Eight weekly visits to complete follow‐up assessments cpd EC use Asthma symptoms Pulmonary functioning, FEV, FVC, FEF25‐75, PEF. CO. Level of exhaled CO assessed with Smokerlyzer NNAL Cotinine Interleukin‐6 (IL‐6) Tumour necrosis factor alpha (TNF‐a) Chemokine ligand 9 (CXCL9) Matrix metallopeptidase 9 (MMP9) |
Starting date | Start date: May 1 2022. Estimated study completion date: May 2023 |
Contact information | Alexander W Sokolovsky, PhD 4018636629, alexander_sokolovsky@brown.edu Mary Ellen Fernandez, BA 4018635521, mary_fernandez@brown.edu |
Notes | New to 2022 update |