The Betel Nut Intervention Trial (BENIT)-A Randomized Clinical Trial for Areca Nut and Betel Quid Cessation: Primary Outcomes.

BACKGROUND: Areca nut and betel quid (ANBQ) chewing is a widespread carcinogenic habit. The BENIT (ClinicalTrials-NCT02942745) is the first known randomized trial designed for ANBQ chewers. METHODS: We compared the intensive behavioral treatment intervention condition (IC) with the control condition (CC) in the BENIT and included a 5-stage early stopping rule. We report the primary analysis at stage 3. English-literate adults in Guam and Saipan who self-identified as ANBQ chewers with tobacco were enrolled between August 2016 and August 2020. IC participants (n = 88) received five in-person sessions over 22 days and a brochure containing quitting advice. CC participants (n = 88) received only the brochure. Participants were assessed at baseline and on day 22 of follow-up. Self-reported chewing status at day 22 was determined by a composite of two survey items with disparate wording and response options for cross-verification. RESULTS: Cessation rates were 38.6% (IC) and 9.1% (CC). Proportional hazards regression revealed a p = 0.0058, which met the Stage 3 criteria for significance, and an estimated reduction in ANBQ chewing for IC compared to the CC of 71% (95% CI: 41%-88%). CONCLUSIONS: Robust self-reported intervention effects at day 22 suggest that intensive cessation programs such as BENIT should be further developed and implemented on a larger scale.

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

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.

Barriers to Quitting Areca Nut Consumption and Joining a Cessation Program as Perceived by Chewer and Nonchewer Populations in Guam.

Background: Areca nut (AN) is a carcinogenic substance consumed by roughly 600 million individuals worldwide with increasing popularity in Guam. In response, a cessation program was developed and implemented in Guam and Saipan. However, to improve its delivery, it is necessary to understand the reasons influencing recruitment and participation, such as why a chewer may not want to quit or join a cessation program. Objective: To explore barriers inhibiting chewers from quitting AN chewing and from participating in a cessation program. Methods: Nine individual and group discussions were facilitated with a convenience sample of 17 chewers and nonchewers in Guam in 2017. The mean age of the participants was 36.4 years. Recurring themes relating to reasons for not quitting and not joining a cessation program were extracted. Results: Results produced three general categories-Sociocultural, Behavioral, and Accessible. Each category encompasses different attributes concerning reasons not to quit chewing (e.g. addiction, enabling community, or belief that AN is harmless), and reasons influencing lack of participation in a cessation program (e.g. time, transportation, or relatability). Conclusions: Current findings suggest chewers are unaware of the harmful effects of AN. Also, they may not comprehend the purpose of a cessation program. In addition, the likelihood of chewers participating in a cessation program is influenced by their level of comfort with the program and personnel, and whether a program addresses their time and transportation limitations.