Effectiveness of Nicotine Replacement Therapy and Behavioral Intervention in Tobacco Cessation-A Tertiary Hospital-Based Randomized Controlled Trial.

Introduction: The effectiveness of nicotine replacement therapy (NRT) on smokeless tobacco (SLT) users is underexplored in India, with prior research primarily focusing on smokers. This study assessed and compared the effectiveness of combining behavioral intervention (BI) and NRT with BI alone on smoking and SLT cessation.

Methods: This 1.5-year prospective, open-label, three-arm parallel-group randomized controlled trial was conducted at the Tobacco Cessation Clinic, SCB Dental College and Hospital, Odisha, India. The three intervention groups-BI, BI+nicotine patch, and BI+nicotine gum-were assessed using a prevalidated proforma on sociodemographics, relevant medical and dental history, oral hygiene practices, and previous tobacco use patterns.

Results: The study enrolled 130 participants. At 26 weeks, 63.3% (19/30) in the BI+patch and 52.9% (18/34) in the BI+gum achieved abstinence, compared to 24.1% (7/29) in the BI group. The odds ratio (OR), 95% confidence interval (CI); p-value of abstinence was 6.03 (1.90-19.15; p=0.003) for BI + patch, and 3.25 (1.08-9.78; p=0.035) for BI+gum. Among SLT users, abstinence was achieved in 70.59% (12/17) with BI+patch (OR 6.40, 95% CI: 1.57-26.03; p =0.010) and 53.85% (14/26) with BI+gum (OR 3.11, 95% CI: 0.92-10.47; p=0.067) versus 27.27% (6/22) with BI alone. Both intervention groups demonstrated significantly reduced relapse risk versus BI alone (Hazard ratio [HR] 0.45, 95% CI: 0.24-0.83; p=0.011) for BI+patch and HR 0.40, 95% CI: 0.22-0.74; p=0.003 for BI+gum.

Conclusion: Combination therapy (BI+NRT) is more effective than BI alone. The BI+patch combination is more effective than BI+gum and BI alone. The NRT intervention groups had higher abstinence rates and reduced relapses than the standard BI group. Further studies are required to validate these findings.

Implications: This study portrays the effectiveness of combining behavioral intervention (BI) with nicotine replacement therapy (NRT) in promoting cessation of tobacco use in smokeless tobacco (SLT) users and reducing relapse rates. The findings highlight the superiority of BI+NRT over BI alone as they demonstrate notable efficacy, higher odds of abstinence, and lower relapse rates in the BI+patch and BI+gum group as compared to the BI group. The study underscores the significance of integrating NRT into cessation programs to enhance long-term outcomes by emphasizing the need for comprehensive approaches and tailored interventions to address the challenges of addiction with a focus on SLT users.