A pilot study of the potential acceptability of vaporised nicotine products for smoking cessation or long-term substitution among smokers

INTERVENTION: 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. 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. CONDITION: Tobacco Dependence PRIMARY OUTCOME: The product selected by the most participants. INCLUSION CRITERIA: 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. 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 SECONDARY OUTCOME: Adverse reactions to the intervention medicines are expected to be mild and self‐limiting and similar to those experienced for the comparator products (e.g. cough, sore throat, headache, nausea). Number, type and severity of adverse events potentially caused by the product measured by self‐report and recorded in product use diary. Adverse Events will be categorised as 1) did not require medical attention 2) Required a visit to doctor 3) required hospitalisation 4) life‐threatening. Measured by participant self‐report and advice from treating doctor for category 4. Average amount of each product used per day over the three days. Measured by dividing the total amount of product used as measured by self report in the product use diary by the number of days the participant used the product for. How easy each product was to use measured on four point Likert scale: How difficult was it to use this product? (very difficult, somewhat difficult, somewhat easy, very easy). How effective each product was in reducing cravings measured by self report on a five point Likert scale: How did this product affect your cravings for cigarettes? (Increased a lot, increased a little, no effect, decreased a little, decreased a lot). How much they liked the product measured by self‐report on a five point Likert scale (disliked a lot, disliked a little, neutral, liked a little, liked a lot). The number of cigarettes smoked per day over the three days for each product compared to baseline, measured by self‐report in product use diary.