A pilot study of the potential acceptability of vaporised nicotine products for smoking cessation or long-term substitution among smokers
A phase 1 study of acceptability and preferences of vaporised nicotine replacement products [18mg/mL nicotine administered by vaporisers (Innokin iTaste VV4 and Cool Fire IV)] compared to standard nicotine replacement products (gum, patch, dissolvable oral strip, mouthspray, inhalator)] or vaporised nicotine-free solution [0% nicotine] in smokers living with HIV.
The University of Queensland
15 participants
Jul 25, 2015
Interventional
Conditions
Summary
The THRIVE Pilot project will examine whether smokers living with HIV find nicotine replacement products acceptable to use as a quit aid or replacement for smoking. This project aims to measure how acceptable and tolerable the participants find the products to use, and which products are preferred. It will also measure whether participants reduce their smoking while using their products. It will also explore whether providing the participants with information about the use of long-term nicotine substitution as an option to reduce health risk increases or decreases their interest in abstaining from cigarettes and nicotine. We will also monitor adverse events while using the products. Tobacco smoking is a major cause of serious disease. Those who quit smoking reduce their risk of developing a tobacco related disease. The project will help us to better understand whether vaporised nicotine products are a more attractive option than existing NRT products for people living with HIV who smoke. We will also measure their interest in and reactions to harm reduction messages about using nicotine products as a long-term substitute for cigarettes if they cannot or are unwilling to quit smoking. People living with HIV who smoke are a population group that are likely to benefit from harm reduction approaches as smoking is particularly harmful for this population group and previous trials have found low long-term success rates with standard abstinence-based approaches. We hypothesise that more participants will find the VNPs acceptable and preferable to use compared to NRTs and that advice on harm reduction options will not decrease interest in quitting smoking, but may decrease interest in stopping nicotine use.
Eligibility
Inclusion Criteria1
- HIV Positive, currently smoking a minimum of 5 tobacco cigarettes per day, aged 18+, sufficiently proficient in English to provide informed consent and to complete questionnaires, not planning to quit smoking in the next month.
Exclusion Criteria13
- pregnant
- breastfeeding
- less than 18 years of age
- Individuals who have any of the following will require clearance from a medical practitioner in order to enrol in the study:
- have had a stroke or heart attack or severe angina in the last two weeks
- poorly controlled high blood pressure
- a mental health/psychiatric condition that is being treated with anti-psychotic medication
- overactive thyroid
- adrenal gland tumour
- kidney or liver disease
- a stomach ulcer
- poorly controlled asthma or other throat or airway disease
- insulin dependent diabetes mellitus
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Interventions
Participants will attend a group demonstration session. In this session participants will be informed about the purpose of the study, and a demonstration on the use of the available nicotine products will be given. Participants will be asked to select up to four nicotine replacement products (up to two standard products and up to two of the intervention devices with the intervention solution of their choice). Products include; Intervention devices 1. Innokin Gladius M tank 2. Innokin iTaste VV4 (Refillable tank-style vaporizer) 3. Innokin CoolFire IV (Refillable tank-style vaporizer) Intervention medicines (for use in the intervention devices) 1. Eliquid 1.8%: 18mg/ml nicotine in PG:VG 50:50 solution 2. EliquidM 1.8%: 18mg/ml nicotine solution in PG:VG 50:50 solution with menthol 3. Eliquid 0%: PG:VG 50:50 solution (nicotine free) 4. EliquidM 0%: PG:VG 50:50 solution with menthol (nicotine free) Intervention device 1 consists of a reservoir tank that is filled with the eliquid, and a heating coil/atomiser to produce the aerosol. It is used in conjunction with intervention device 2 or 3. Intervention device 2 contains a variable voltage 750mAh battery. It physically resembles a large fountain pen. Intervention device 3 contains a more powerful 2000mAh battery and is rectangular in shape and fits in the palm of the hand. Dose and frequency of use will be on an as needed basis to achieve reduction in cravings for cigarettes. Participants will be advised to replace as many cigarettes as possible with the trial product during the three days. They will also be advised that average use of eliquid is around 2-3 mLs per day, but this may be higher or lower depending on how many cigarettes they smoke. Packs containing enough of each of the selected products for at least three days of use will be sent to participants. One pack will be sent per week with written instructions and a demonstration video on how to use the product. The order that the products are sent to participants will be randomised to reduce order effects. However, due to delay in receiving some products from overseas (nicotine solutions), standard NRTs were sent in the first two weeks (in random order). Participants will be able to phone the research team if they experience any difficulties. Participants will be asked to try each product for at least three days and attempt to replace as many cigarettes as possible with the trial product. Participants will be called weekly in order to collect feedback on their experiences, and to answer any questions the participants may have. Participants will be asked to keep a product diary designed by the research team to record their experiences with each product at the end of each week. Total trial duration for testing four products is four weeks. A washout period has not been specified. After all the products have been trialed the participant will be invited to attend a face-to-face interview where product diaries and any unused products and the devices will be collected. The interview will aim to collect data on the participants’ experiences with the products using both closed- and open-ended questions Participants will be shown a video that explains that while quitting all nicotine use has the greatest health benefit, long-term use of clean nicotine products is less harmful than continuing to smoke. After trialing the products, the participants will participate in a semi-structured interview which will include discussion of their views on this strategy of long-term substitution and how the information affected their interest in quitting cigarettes and nicotine.
Locations(1)
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ACTRN12615000829516