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. 2022 Nov 17;2022(11):CD010216. doi: 10.1002/14651858.CD010216.pub7

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:
  • 21 to 65 years

  • Persistent asthma symptoms (i.e. episodic symptoms of airflow obstruction/airway hyper‐responsiveness (AHR) as documented in review of medical history)

  • Currently prescribed SABA medication

  • Past‐year smoking of ≥ 5 cigarettes/day (CO ≥ 6 ppm at baseline)

  • Zero breath alcohol during informed consent for participation


Exclusion criteria:
  • Intention to quit smoking during the next 30 days or current engagement in any smoking cessation treatment

  • Regular EC/ENDS user or using ENDS > 2 days/week

  • Medical contraindication to nicotine

  • Pregnancy (due to toxicity of nicotine and tobacco products)

  • Current alcohol dependence (AUDIT > 15)

  • Urine‐screened or past‐month self‐reported use of illicit substances (amphetamine, cocaine, methamphetamine, opioids, benzodiazepines)

  • Current psychosis, mania, or suicidal ideation

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