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A Randomized Controlled Trial to Assess the Long-Term Health Effects of Smoking Cessation Intervention through a Tobacco Harm Reduction Product among Type 2 Diabetic Smokers in Bangladesh- Study Protocol of the DISC Trial

Farhana Haseen*, As-Saba Hossain, Nafis Rahman, Asif Moinur Chowdhury, Sohel Rana, Tanver Hossain, Shamima Islam, Hasna Heena Mahmud, Joanne Coyle, Jyoti Goyal, Gabriel Barnard, Neil McKeganey

Background: Evidence suggests patients with type 2 diabetes who smoke are at increased risk of developing health complications and premature death. Incorporating tobacco cessation intervention within regular care for people with diabetes would provide a valuable opportunity to support this vulnerable group quitting combustible tobacco. A novel category of reduced-risk tobacco products, Oral Nicotine Pouches (ONPs), has recently emerged. There is no evidence on how effective ONPs are for smoking cessation among people with pre-existing chronic health conditions, like diabetes. Globally, Bangladesh is one of the top ten countries with the highest adult smoking rates and the number of adults with diabetes. Therefore, this clinical trial will assess the long-term health effects of smoking cessation through an ONP intervention among type 2 diabetic patients in Bangladesh.

Methods: The study is a two-arm Randomized Control Trial (RCT) to be conducted in three phases: A 12-week intervention, a four-week phase-out, and a follow-up assessment at Month-6, Month-9, and Month-12. Type 2 diabetic patients (n=440) recruited from a clinical setting will be randomized to either the intervention or the control group (1:1 ratio). The intervention group will receive 6 mg dry ONPs over 12 weeks, with tapering doses for the next 4 weeks (3 mg for 2 weeks and 0 mg for 2 weeks). The control group will be in usual diabetic care for the entire study period. The primary study outcomes measures include 7-day point prevalence smoking abstinence validated by expired-air carbon monoxide at week-12, and clinical outcomes (pulmonary, liver, and kidney functions; inflammatory biomarker, body composition, blood glucose and HbAc1, blood pressure, and lipid profile) at week- 12 and week-52. Secondary outcomes are changes in cigarette consumption, side-effects, use, acceptability, and reasons for using ONPs; use of other tobacco, nicotine products, and smoking cessation methods; and suitability of intervention.

Discussion: This RCT will provide strong evidence to determine the health impact of a tobacco harm reduction product and valuable insights into the overall potential of smoking cessation in reducing complications in patients with diabetes and significantly contribute to policy decisions.