Areca nut, the seed of the Areca catechu L. palm evaluated to be a Group 1 carcinogen, is still chewed by 10-20% of the world population. It is often chewed with Piper betle L. leaf and other ingredients such as slaked lime and tobacco, to form a betel quid. Globally, areca nut/betel quid is the fourth most commonly used psychoactive substance after tobacco, alcohol, and caffeine. Unlike tobacco cessation, systematic research on areca nut/betel quid cessation is rare. The negative health effects associated with areca nut/betel quid consumption warrant the need for an evidence-based cessation program. Consequently, the Betel Nut Intervention Trial (BENIT) was initiated in August 2016. The BENIT is a randomized, controlled, superiority trial designed to test the efficacy of an intensive areca nut/betel quid cessation program, and to quantify the efficacy through bio-verification. The trial is ongoing in Guam and Saipan in the Mariana Islands. Adult areca nut/betel quid chewers, 18 years and older who include tobacco in their betel quid, are being enrolled into the trial. Those enrolled are assessed for the primary outcome (chewing status) and the secondary outcome (saliva bio-verification) at baseline, at 22 days, and at 6 months. The areca nut/betel quid chewers randomized into the control arm receive an educational booklet only. The areca nut/betel quid chewers randomized into the intervention arm receive the educational booklet and a 22-day cessation program modeled after a smoking cessation program and led by trained facilitators. To date, 224 chewers have been enrolled into the BENIT. The current quit percentages are 18% in the experimental group and 8% in the control group, though these results may change as the trial progresses. The BENIT is designed to provide evidence of the efficacy of a cessation program to help areca nut/betel quid with tobacco chewers to quit chewing. Although the current intervention trial focuses on Guam and Saipan, it has the potential for greater regional and global importance. TRIAL REGISTRATION: Clinical Trial # NCT02942745.

Citation Format: Yvette C Paulino, Lynne R Wilkens, Patrick P Sotto, Adrian A Franke, Crissy T Kawamoto, Jade SN Chennaux, Ana J Mendez, Lynette F Tenorio, Grazyna Badowski, Pallav Pokhrel, Thaddeus A Herzog. Introduction of a randomized controlled trial on areca nut/betel quid cessation: The Betel Nut Intervention Trial (BENIT) [abstract]. In: Proceedings of the Twelfth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2019 Sep 20-23; San Francisco, CA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2020;29(6 Suppl_2):Abstract nr C081.