Very low nicotine content (VLNC) tobacco use trial
| ISRCTN | ISRCTN37490746 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN37490746 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | University of Auckland |
| Funder | University of Auckland |
- Submission date
- 19/03/2025
- Registration date
- 20/03/2025
- Last edited
- 22/08/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Other
Plain English summary of protocol
Background and study aims
This study aims to understand how people who smoke might behave if very low nicotine content (VLNC) cigarettes were the only tobacco available in New Zealand. The researchers want to see if people are interested in participating in a trial involving smoking and to explore their reactions to using VLNC cigarettes.
Who can participate?
Adults aged 18 or older who currently smoke (at least once a month and have smoked more than 100 cigarettes in their lifetime) and live in New Zealand can participate. Participants must be willing to smoke a VLNC cigarette, able to travel to the study site, and able to read and write in English. Pregnant or breastfeeding individuals, those trying to become pregnant in the next three months, those currently using smoking cessation medication, and those who have previously smoked VLNC cigarettes are not eligible.
What does the study involve?
Participants will be randomly assigned to one of three groups:
1. Smoking a VLNC cigarette and viewing health messages about VLNC cigarettes.
2. Smoking one of their own cigarettes and viewing health messages about VLNC cigarettes.
3. Smoking one of their own cigarettes without viewing health messages.
Participants will complete a baseline questionnaire about their smoking history, mental health, and perceptions of tobacco and other nicotine products. They will then follow the study procedures based on their assigned group. After completing the tasks, participants will answer follow-up questions about their smoking preferences, potential use of illicit tobacco, and willingness to quit.
What are the possible benefits and risks of participating?
Participants will receive a $100 voucher for their time and travel costs. They will also receive information on smoking cessation support, including a referral for subsidised nicotine replacement therapy. The study has minimal risks, and participation is voluntary. Participants can withdraw at any time without consequences.
Where is the study run from?
University of Auckland (New Zealand)
When is the study starting and how long is it expected to run for?
September 2024 to December 2026.
Who is funding the study?
University of Auckland (New Zealand)
Who is the main contact?
Prof. Chris Bullen, c.bullen@auckland.ac.nz
Dr Pyi Pyi Phyo, pyi.pyi.phyo@auckland.ac.nz
Contact information
Principal investigator
University of Auckland
Auckland
1023
New Zealand
| 0000-0001-6807-2930 | |
| Phone | +64 21415267 |
| c.bullen@auckland.ac.nz |
Public, Scientific
University of Auckland
Auckland
1010
New Zealand
| 0009-0005-4425-9449 | |
| Phone | +64 2102247741 |
| pyi.pyi.phyo@auckland.ac.nz |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Three-arm parallel-group open-label pilot randomized trial |
| Secondary study design | Randomised controlled trial |
| Participant information sheet | 47034 VLNC Pilot Trial_PISV3_06Mar2025_clean.pdf |
| Scientific title | A pilot randomised trial exploring the intentions of people who smoke, to seek illicit tobacco if very low nicotine content (VLNC) cigarettes were the only tobacco available in New Zealand |
| Study acronym | VeLoNic |
| Study objectives | It is feasible to conduct a full-scale randomised controlled trial assessing the impact of VLNC cigarette availability and reading health messages about VLNC cigarettes on smoking behaviors and illicit tobacco-seeking intentions, as determined by: 1. Achievable recruitment rates and the time required to recruit participants. 2. Participant attendance and completion of study tasks. 3. Participant comprehension of questionnaires and study procedures. 4. The ability of the study to effectively capture relevant participant responses. 5. Identification of any reported difficulties encountered during the study. 6. Incidence of any reported adverse events related to participation. |
| Ethics approval(s) |
Approved 12/03/2025, University of Auckland Human Participants Ethics Committee (UAHPEC) (Level 3, 49 Symonds Street, Auckland, 1010, New Zealand; +64 (09) 373 7599 Ext 83711; humanethics@auckland.ac.nz), ref: UAHPEC28879 |
| Health condition(s) or problem(s) studied | Smoking |
| Intervention | Participants will be given a hypothetical scenario where all smoked tobacco legally available for purchase in New Zealand has 95% less nicotine than the tobacco they normally smoke. Participants will then be randomised to: 1) smoking a VLNC cigarette and viewing health messages about VLNC cigarettes, 2) smoking one of their own cigarettes and viewing health messages about VLNC cigarettes, or 3) smoking one of their own cigarettes. All data will be collected from each participant within an hour on one day |
| Intervention type | Mixed |
| Primary outcome measure(s) |
The main focus of the trial is to determine whether a larger trial would be feasible to conduct based on the following criteria. |
| Key secondary outcome measure(s) |
The secondary focus of the trial is to gather data on the likely impact of the tested interventions on potential participant behaviours. The secondary outcome measures will be measured immediately after smoking and reading the health messages on VLNC cigarettes under the hypothetical scenario of all smoked tobacco legally available for purchase in New Zealand having 95% less nicotine than the tobacco they normally smoke. Specifically: |
| Completion date | 31/12/2026 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 30 |
| Key inclusion criteria | 1. Currently smoke (defined as people who have smoked more than 100 factory-made cigarettes and/or roll-your-own (RYO) cigarettes in their lifetime and currently smoke at least once a month 2. Live in New Zealand 3. Are aged ≥18 years 4. Are able to provide consent 5. Are able to read and write English 6. Are willing to smoke a VLNC cigarette 7. Are willing to travel to the study site |
| Key exclusion criteria | 1. Are pregnant/breastfeeding or are women trying to become pregnant in the next three months 2. Are currently using smoking cessation medication (including using e-cigarettes daily for the last month) 3. Have ever smoked VLNC cigarettes |
| Date of first enrolment | 14/03/2025 |
| Date of final enrolment | 30/04/2025 |
Locations
Countries of recruitment
- New Zealand
Study participating centre
Grafton Campus
Auckland
1010
New Zealand
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan | Not expected to be made available due to consent not obtained to do so. The data will be stored securely for six years, per the University of Auckland's Research Code of Conduct. After this, they will be destroyed through the confidential document destruction service at the University of Auckland. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 3 | 06/03/2025 | 20/03/2025 | No | Yes |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Protocol file | version 3 | 07/03/2025 | 20/03/2025 | No | No |
Additional files
- 47034 VLNC Pilot Trial_PISV3_06Mar2025_clean.pdf
- Participant information sheet
- 47034 VLNC Pilot Trial_Protocol V3_07Mar2025_Clean.pdf
- Protocol file
Editorial Notes
22/08/2025: The completion date was changed from 31/12/2025 to 31/12/2026.
19/03/2025: Trial's existence confirmed by University of Auckland.