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Investigating the long-term impact of nicotine replacement products on tobacco smoking cessation for low-socioeconomic status smokers

Investigating the long-term impact of nicotine replacement products on tobacco smoking cessation for low-socioeconomic status smokers

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12622001147774
Enrollment
45
Registered
2022-08-22
Start date
2022-11-02
Completion date
2023-10-26
Last updated
2023-04-17

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

Conditions

None listed

Brief summary

Participants of ACTRN12621000076875 were allocated a specific nicotine replacement product (vaporised nicotine product or oral nicotine replacement therapy [nicotine gum or lozenge]) at baseline. This observational extended follow-up study investigates participants that successfully quit smoking (met trial primary outcome) in ACTRN12621000076875, Participants will be followed up at 19 months to determine long-term smoking abstinence, as well as examine patterns of long-term use of nicotine products. Participants may be asked to provide a salivary sample for cotinine analysis and complete a carbon monoxide breath test.

Interventions

Participants of ACTRN12621000076875 were allocated a specific nicotine replacement product (vaporised nicotine product or oral nicotine replacement therapy [nicotine gum or lozenge]) at baseline. This observational extended follow-up study investigates participants that successfully quit smoking (met trial primary outcome) in ACTRN12621000076875. Participants will be invited to take part/consent to the long-term follow-up study after their participation in ACTRN12621000076875 is complete (eg.

Participants of ACTRN12621000076875 were allocated a specific nicotine replacement product (vaporised nicotine product or oral nicotine replacement therapy [nicotine gum or lozenge]) at baseline. This observational extended follow-up study investigates participants that successfully quit smoking (met trial primary outcome) in ACTRN12621000076875. Participants will be invited to take part/consent to the long-term follow-up study after their participation in ACTRN12621000076875 is complete (eg. 7-month interview and breath test completed). This follow-up study involves a 15 minute telephone interview with a member of the research team at 19-months post baseline interview for ACTRN12621000076875. All participants will be asked to provide a salivary sample (collection kits sent and received via registered post) for analysis for presence of cotinine. The analysis will be completed by an independent laboratory in New South Wales, Australia. Participants that meet the self-reported abstinence outcome of less than or equal to 5 cigarettes in the 12-month period since their last interview (at the 19-month interview) will be asked to complete a carbon monoxide breath test. The breath test can be completed in-person or over a video call with a member of the research team.

Sponsors

University of New South Wales
Lead SponsorUniversity

Eligibility

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

Inclusion criteria

Participants can be included if they meet the primary outcome of six-month continuous abstinence in ACTRN12621000076875 (defined as self-report of having smoked less than or equal to 5 cigarettes in that time and carbon monoxide level of less than or equal to 5ppm using biochemical breath test verification) and provide informed consent.

Exclusion criteria

There are no exclusion criteria.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026