Varenicline and nicotine replacement therapy for smokers admitted to hospitals

There is one intervention arm in this study. Participants in the intervention arm will receive varenicline plus NRT lozenges for a duration of 12 weeks. An additional 12 weeks course of varenicline and NRT lozenges will be provided (i.e. 24 weeks in total) to those who need further support (this will be determined by the Research Assistant and site coordinators in charge of delivering the intervention based on the participant’s nicotine dependence, adherence to treatment, and any adverse events). VARENICLINE Varenicline will be provided as oral tablets. According to the product information sheet of varenicline, the standard dosing schedule used will be as follows: Days 1-3 = one 0.5mg tablet once daily Days 4-7 = one 0.5mg tablet twice daily Day 8 onwards = one 1mg tablet twice daily The dose of varenicline will be adjusted based on the participant's renal function. According to the product information sheet, no dose adjustments are required for mild to moderate renal impairment. For participants with CrCl <30 mL/minute dosing will begin at 0.5mg once daily for the first 3 days then increased to 1mg once daily if tolerated as is recommended by the Australian Medicines Handbook 2018. The dose of varenicline will also be adjusted for participants who experience severe or intolerable nausea on standard dosing. A Research Assistant will check how such participants take varenicline in relation to food and water (may help if taken with or just after food) and if needed the dose will be lowered to 1mg once daily as recommended by the Australian Medicines Handbook 2018. Participants will receive varenicline immediately after randomisation and will be advised to start the medication soon after they receive it. All participants will be asked to completely abstain from smoking if possible or at least reduce their smoking over the first seven days of the varenicline course and to aim to quit completely within one to two weeks of starting varenicline. Along with the medication, participants will be given Consumer Medicines Information (CMI) sheets highlighting key information about the dosing schedule and important adverse effects to be aware of. A trained Research Assistant will give clear verbal counselling to the participants along with a leaflet clearly stating the dosing regimen, the most common adverse events, emergency contact details and information on how to obtain a renewal of their medication. NRT LOZENGES The dose of NRT lozenges to be used is as follows (adopted from the product information sheet for combination NRT) Lozenges should be taken only when there is an urge to smoke. Take a lozenge (2mg) as required when you have an urge to smoke up to every 1-2 hours as needed. You must not use more than 15 lozenges in a day. 1. Place one lozenge on the tongue and suck until the taste becomes strong 2. Rest the lozenge between the gum and cheek 3. When the taste fades start sucking the lozenge again 4. Repeat this process until the lozenge completely dissolves (it takes about 30 minutes) Participants will receive NRT lozenges immediately after randomisation (i.e. at the same time as varenicline). They will be informed to start the medication (or placebo) soon after they receive it. As with varenicline, participants will receive a Consumer Medicines Information (CMI) sheet highlighting key information about the lozenges including information on how to take the lozenges and some common side effects of which to be aware. A trained Research Assistant will give clear verbal counselling to all participants along with a leaflet clearly stating the dosing regimen, the most common side effects, emergency contact details and information on how to obtain a renewal of their medication. ADHERENCE Adherence to study medication will be assessed at each of the follow-ups. The first of these will be one week after the initiation of treatment. A Research Assistant will contact the participants (in hospital for those that are still inpatients or over the phone for participants who have been discharged) and will ask them about their adherence to the study medicines. Adherence will also be assessed over the telephone at 3 weeks from the start of treatment, at three months and six months from treatment initiation by a Research Assistant. Research Assistants involved in the 3 and 6 month follow-up interviews/calls will be blinded to the participants treatment allocation and will be different from the Research Assistants involved in the recruitment/ randomisation phase of the study. To promote adherence to study medicines participants will be sent automated text messages once a week for the first month of treatment, then once every month. Text messages will be sent by Quitline or by a Research Assistant using the ClickSend system. Text messages will reinforce the importance of adherence to the study medications, long-term abstinence and also contain emergency contact details for the participants. Participants who do not have a cell phone will be called on their land phone by the Research Assistant instead of sending text messages. QUITLINE Participants in both arms will be informed about and encouraged to use behavioural support from Quitline as per Quitline standard protocols. Using Quitline support is not a requirement for participation in the study. The number of Quitline calls a participant has made will be recorded during the follow-ups at three and six months from treatment initiation.