None listed
Conditions
Brief summary
Many smokers who try to quit fail in their attempt. Medicinal nicotine is currently only used as a short-term quit aid. This trial will test if offering smokers the option of using these products as long-term substitutes for cigarettes will help more smokers to successfully quit. We will also determine if offering smokers electronic nicotine delivery systems in addition to medicinal nicotine products further increases the number of smokers who quit successfully.
Interventions
Condition A (Comparator): Participants in this condition will receive: 1) A factsheet that explains the relative harmfulness of NRT compared to cigarettes; 2) A free sample of NRT products (1-2 days supply of choice of any three of gum, lozenge, inhaler or mouthspray) and instructions for use of the products. Participants will be told the products are designed to help them quit, and that the recommended use is for 8-12 weeks. Advice on recommended dose will be provided and the amount supplied fo
Condition A (Comparator): Participants in this condition will receive: 1) A factsheet that explains the relative harmfulness of NRT compared to cigarettes; 2) A free sample of NRT products (1-2 days supply of choice of any three of gum, lozenge, inhaler or mouthspray) and instructions for use of the products. Participants will be told the products are designed to help them quit, and that the recommended use is for 8-12 weeks. Advice on recommended dose will be provided and the amount supplied for free will be determined from the participant’s cigarette intake and the recommended dosage schedule. However, participants will be able to use their discretion as to their individual dose. Participants may choose one of the products or a combination of two to use for a quit attempt; 3) Approximately three week’s worth of the participant's chosen NRT product (or a combination of two products, if this is their preference) will be supplied for free; and 4) Access to these products for a further 6 months at a price that reflects their lower harmfulness compared to cigarettes (ie significantly cheaper than retail price of cigarettes and lower than current retail prices for NRT). These purchases will be made via a secure website controlled by the research team. Condition B: Participants in this condition will receive: 1) A factsheet that explains the relative harmfulness of NRT compared to cigarettes similar to that provided for Condition A, but with further information on the benefits of both options (short term quit aid or long-term substitute) compared to smoking. It will emphasise complete cessation as the best option from a health perspective; 2) A free sample of NRT products (1-2 days supply of choice of any three of gum, lozenge, inhaler or mouthspray) and instructions for use of the products. Participants will be told how to use the products as a short term quitting aid (recommended use for 8-12 weeks), but also encouraged to continue using the product if they find they need to in order to refrain from smoking. Advice on recommended dose will be provided and the amount supplied for free will be determined from the participant’s cigarette intake and the recommended dosage schedule. However, participants will be able to use their discretion as to their individual dose. Participants may choose one of the products or a combination of two to use for a quit attempt; 3) Approximately three week’s worth of the participant's chosen NRT product (or a combination of two products, if this is their preference) will be supplied for free; and 4) Access to these products for a further 6 months at a price that reflects their lower harmfulness compared to cigarettes (ie significantly cheaper than retail price of cigarettes and lower than current retail prices for NRT). These purchases will be made via a secure website controlled by the research team. Condition C: Participants in this condition will receive: 1) A factsheet that explains the relative harmfulness of NRT compared to cigarettes with information on the benefits of both options (short term quit aid or long-term substitute) compared to smoking similar to that provided for Condition B, but with additional details on the risk profile of Electronic Nicotine Delivery Systems compared to both NRT and stopping all nicotine use. It will emphasise complete cessation as the best option from a health perspective; 2) A free sample of 1-2 days supply each of up to four products and instructions for use of the products. Participants may select from NRT products (gum, lozenge, inhaler, mouthspray) and an electronic nicotine delivery system. Participants will be told how to use the products as a short term quitting aid (recommended use for 8-12 weeks), but also encouraged to continue using the product if they find they need to in order to refrain from smoking. Advice on recommended dose will be provided and the amount supplied for free will be determined from the participant’s cigarette intake and the recommended dosage schedule. However, participants will be able to use their discretion as to their individual dose. Participants may choose one of the products or a combination of two to use for a quit attempt; 3) Approximately three week’s worth of the participant's chosen NRT product (or a combination of two products, if this is their preference) will be supplied for free; and 4) Access to these products for a further 6 months at a price that reflects their lower harmfulness compared to cigarettes (ie significantly cheaper than retail price of cigarettes and lower than current retail prices for NRT). These purchases will be made via a secure website controlled by the research team.
Sponsors
The University of Queensland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Current daily smokers (at least 6 cigarettes/day); ability to read and understand English; agree to receive samples of nicotine products and to try the samples; and willing to complete surveys over 12 months.
Exclusion criteria
Currently being treated for Serious cardiovascular disease (eg heart disease, stroke), Cancer, A mental health condition that is being treated with regular medication, High blood pressure that is not controlled, Have a stomach ulcer, Have kidney or liver disease, Have an overactive thyroid or adrenal gland cancer, Use insulin for diabetes, Have asthma or chronic throat disease, pregnant or planning to become pregnant or expecting to be breastfeeding within the next 12 months.
Outcome results
None listed