Use of Nicotine Replacement Therapy (NRT) Sample and Brief Smoking Cessation Advice for Recruiting Smokers to Smoking Cessation Services and Motivating Quit Attempts

Study design

The proposed project has 4 phases: (1) Training of SC ambassadors (SCAs) for the SC promotion; (2) SC promotion sessions to deliver the medication counselling and NRT sampling (experimental group), or the advice to use NRT only (control group); (3) Follow-up of the recruited smokers; (4) Evaluation of the effectiveness of training, promotions, and use of NRT sampling. To examine the effectiveness of NRT sampling for recruitment and quitting, a multi-site cluster RCT (allocation ratio 2:1) will be used. All promotion sessions will be randomly allocated to either the experimental or the control group. The experimental group will receive medication counselling and NRT samples, while the control group only receive the advice to use NRT. Both groups are advised to enroll in any smoking cessation service in Hong Kong. Because smokers who receive NRT sampling will be more likely to participate in the study, the experimental sessions will then recruit more smokers than the control sessions. Hence, the allocation ratio of participants is arbitrarily set at 2:1. To increase comparability between the two groups, the promotion sessions of one hotspot will be randomly allocated to either group. All recruitment and quitting outcomes in the smokers between the experimental and control group will be compared.

Subjects

Smokers with the following inclusion criteria will be invited to participate in our RCT: (1) Hong Kong residents, (2) aged 18 to 65 years, (3) have used any tobacco products in the past month, (4) able to read and speak Chinese, (5) have not used NRT for the past month, (6) no severe angina, serious cardiac arrhythmias and hypertension, (7) have not suffered acute myocardial event in the past 4 weeks, (8) neither pregnant nor breastfeeding, (9) not under medication and treatment due to mental illness. To confirm the smoking status, in those who use conventional cigarettes, smokers' exhaled carbon monoxide will be measured on-site. Nurses will measure the blood pressure if smoker is aged over 50 years old, obese by observation, or upon patient requests.

The inclusion criterion no. 3 was "smoke 10 cigarettes or more per day in the past week" and is amended to "have used any tobacco products in the past month". The initial intention of setting the inclusion criteria of at least 10 cigarettes per day (CPD) is to recruit smokers who have moderate to strong level of craving and a greater need for NRT. However, we also recognize that one of the objectives of the research is to promote the use of NRT for quit attempts with NRT sampling. In fact, smokers who smoke less than 10 CPD can also benefit from using NRT gums. Therefore, the change in the inclusion criteria does not deviate from our research aim. In contrast, with the removal of the criterion for CPD, we will be able to reach out to a larger group of smoking population and encourage more smokers to use NRT to quit smoking.