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Very low nicotine content (VLNC) tobacco use trial

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN37490746
Enrollment
30
Registered
2025-03-20
Start date
2025-03-14
Completion date
Unknown
Last updated
2025-09-08

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

Conditions

Smoking Other

Interventions

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

Sponsors

University of Auckland
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
The main focus of the trial is to determine whether a larger trial would be feasible to conduct based on the following criteria. 1. Can people be recruited, and how quickly can they be recruited? This will be measured by - the number of participants recruited in a month - the number of participants in each ethnic group (NZ Europeans, Maori, Pacific people, Asian, Middle Eastern/Latin American/African and other ethnicity) as defined by Stat NZ (level 1 classification) - the number and proportion of participants in priority and non-priority populations. Priority populations are defined as people with self-reported anxiety and/or depression, young people (aged 18-30 years) of low educational attainment or individuals who report heavy alcohol and/or cannabis use (following the same definitions as the CENIC-NZ study. 2. Do people attend the study site on their scheduled day and stay for their required time? This will be measured by using on-site attendance records. 3. Are the study tasks and questionnaires understandable to participants? Specific questions will be asked in the questionnaire. 4. Are all questions answered? This will be determined by counting the number of unanswered questions in the questionnaire. 5. Did participants highlight any difficulties with the trial? This will be measured by using the onsite records and feedback from the study participants. 6. Did participants face any adverse events or symptoms after smoking a VLNC cigarette? This will be measured by using the onsite records and feedback from the participants.

Secondary

MeasureTime frame
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: 1. Their likelihood of using specific harmful products, measured using a 7-point Likert scale ranging from 0 to 6, where 0 is ‘very unlikely’ and 6 ‘very likely’. These products include: 1.1. VLNC cigarettes. 1.2. Illicit tobacco (i.e., tobacco with regular nicotine levels). 1.3. Homegrown tobacco (i.e., strictly self-grown tobacco. In New Zealand, individuals are allowed to manufacture up to 5kg of home-grown tobacco per adult per year for personal use. This amount translates to approximately 50 to 100 cigarettes per person daily, depending on the tobacco content per each cigarette. However, this tobacco is strictly for personal consumption and cannot be sold or shared). 1.4. Nicotine e-cigarette (vapes). 1.5. Heated tobacco products. 1.6. Nicotine Replacement Therapy (i.e., nicotine gum, patches, or nicotine lozenges or nicotine mouth spray). 1.7. Alcohol. 1.8. Cannabis/Marijuana/ Tetrahydrocannabinol products. 1.9. Other illicit drugs. 1.10. Their desire to quit smoking. 2. Their likelihood to add nicotine to low-nicotine cigarettes or other smoked tobacco was measured using a 5-point scale running from 0 to 4, where 0 is ‘never’ and 4 is ‘daily’. 3. The maximum amount they are willing to pay per VLNC cigarette is measured in New Zealand dollars. 4. If the participants select 1 and above on the 7-point Likert scale for illicit tobacco, the following questions will be triggered: 4.1. The maximum amount you are willing to pay per illicit cigarette, measured in New Zealand dollars. 4.2. The maximum t

Countries

New Zealand

Contacts

Public ContactPyi Pyi Phyo
pyi.pyi.phyo@auckland.ac.nz+64 2102247741

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026