Rationale and design of a randomized, controlled, superiority trial on areca nut/betel quid cessation: The Betel Nut Intervention Trial (BENIT)

Abstract Background Areca nut (AN) is the seed endosperm of the Areca catechu L. palm and a Group 1 carcinogen chewed by 10–20% of the world population. AN is often chewed with Piper betle L. leaf, slaked lime, and tobacco to form a betel quid (BQ). The negative health effects associated with AN/BQ consumption warrant the need for an evidence-based cessation program. However, systematic research on AN/BQ cessation is rare. Methods/design The Betel Nut Intervention Trial (BENIT; trial #NCT02942745) is a randomized controlled trial designed to test the efficacy of an intensive AN/BQ cessation program. The trial is ongoing in Guam and Saipan with adult chewers who include tobacco in their BQ. Enrolled participants are assessed for their primary (chewing status) and secondary (saliva bio-verification) outcome at baseline, 22 days, and 6 months. Participants randomized into the control arm receive an educational booklet while those 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. Information on chewing behavior (history, reasons for chewing, and AN/BQ composition and dependency) are collected. The intervention effectiveness is assessed using the logistic mixed model to compare cessation status between randomization groups. Discussion AN/BQ chewing affects a large population of people, many of whom live in low and moderate income countries in the Asia-Pacific region. Although the BENIT focuses on chewers in Guam and Saipan, it has the potential for greater regional and global importance.