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Feasibility and Participant acceptability of use of the UriSWAB™ collection system

Feasibility and Participant acceptability of use of the UriSWAB™ collection system in individuals attending smoking cessation and respiratory medicine clinics.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12621001057875
Enrollment
22
Registered
2021-08-11
Start date
2021-09-16
Completion date
2021-11-23
Last updated
2022-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Biochemical validation is the gold standard of measuring smoking abstinence in smoking cessation clinical trials. It increases scientific rigor, however, feasibility of sample collection and stability of samples before testing can be a drawback in clinical trials. This study has the potential to establish acceptability of a novel urine collection method, and to test the feasibility of remote sample collection and stability of urine samples using the UriSWAB™ over time. If effective, this method will allow remote biochemical validation of smoking abstinence, which will be useful in larger scale smoking cessation clinical trials in the future.

Interventions

We will recruit 20 current smokers and/or e-cigarette users and/or people using nicotine replacement therapy that attend smoking cessation clinics, outpatient clinics or in-patient wards. Potential participants will be asked if they are interested to participate in the observational study, in person whilst in clinic. The clinicians in clinic will identify smokers or those using nicotine replacement therapy or eCigs based on clinical assessment (standard of care). Each potential participant will

We will recruit 20 current smokers and/or e-cigarette users and/or people using nicotine replacement therapy that attend smoking cessation clinics, outpatient clinics or in-patient wards. Potential participants will be asked if they are interested to participate in the observational study, in person whilst in clinic. The clinicians in clinic will identify smokers or those using nicotine replacement therapy or eCigs based on clinical assessment (standard of care). Each potential participant will be offered a patient information sheet and consent form telling them about the study. They will have an opportunity to accept invitation on the day, or next time they present to clinic. Relevant demographic data will be recorded. Medical History, smoking variables and current medications will also be recorded. Patient demographic and clinical data will be collected from patients electronic or paper based medical records using a structured data collection form, the case report form (CRF). On the day of clinic (in either an outpatient or inpatient setting) an exhaled Carbon Monoxide reading will be collected (standard of care), and the ppt will be asked to provide a urine sample in a standard urine sample container and a UriSWAB™ sample. This collection of samples will be collected contemporaneously.

Sponsors

The University of Queensland
Lead SponsorUniversity

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

• >/= 18 years old • Current or former smoker using Nicotine Replacement Therapy (NRT) and or e-cigarettes

Exclusion criteria

• Patient refusal

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026