Areca nut, also known as betel nut, is the fourth most commonly consumed psychoactive substance in the world, following only alcohol, nicotine, and caffeine in prevalence of consumption. Although betel nut is chewed by approximately 600 million people globally, its use is concentrated in South Asia, Southeast Asia, and some Pacific Islands. Betel nut has been classified as a Group 1 carcinogen by the International Agency for Research on Cancer. Despite the global significance and carcinogenicity of betel nut, there has been very little behavioral or psychological research about betel nut chewing, and there has been no systematic research on the topic of betel nut cessation interventions. The current intervention builds directly upon the National Institutes of Health - National Cancer Institute's U54 University of Guam/University of Hawaii Cancer Center Comprehensive Partnership to Advance Health Equity. Previous data collected through the partnership suggest that betel nut chewers, like smokers, generally want and intend to quit, but do not have specific plans of how or when they will quit. In addition, most betel nut chewers in the partnership's previous study already have tried to quit on one or more occasions. The findings suggest that betel nut chewers could benefit from cessation programs modeled after smoking cessation programs. During 2014, partnership investigators conducted a feasibility study of the betel nut cessation program. The program was well received and yielded surprisingly high rates of self-reported betel nut cessation.
Specific Aim 1. To test the efficacy of an intensive group-based betel nut cessation program.
Specific Aim 2. To quantitatively determine the efficacy of the group-based betel nut cessation intervention trial using bio-verification.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Condition (as posted)
Mapped entity
Match
Confidence
Betel Nut Chewer
—
UNRESOLVED
—
Tobacco Cessation
—
UNRESOLVED
—
Interventions
Interventions (2)
Intervention
Type
Mapped drug
Match
Betel Nut Cessation Booklet
Behavioral
—
UNRESOLVED
Betel Nut Cessation Social Support
Behavioral
—
UNRESOLVED
Design
Arms and outcomes
Arms (2)
type
PLACEBO_COMPARATOR
label
Control
description
Minimal interaction between participant and facilitator regarding cessation strategies. Participants will only be given a betel nut cessation booklet.
interventionNames
Behavioral: Betel Nut Cessation Booklet
type
EXPERIMENTAL
label
Experimental
description
Intensive 5-session intervention program over the span of 22 days, with an additional follow up session after 6 months. The sessions will utilize betel nut cessation social support groups, as well as interactive discussion on how to quit chewing.
interventionNames
Behavioral: Betel Nut Cessation Social Support
Behavioral: Betel Nut Cessation Booklet
Primary outcomes (2)
measure
Eligibility
Eligibility (as posted)
Sex
All
Minimum age
18 Years
Show eligibility criteria text
Inclusion Criteria:
* Self-described betel nut chewer (chewed betel nut for at least 1 year, and at a rate of at least 3 days per week). Must chew a quid consisting of areca nut, slaked lime, betel leaf, tobacco, and/or other optional ingredients.
* Age ≥ 18 years
* Reside in Guam or Saipan
* Able to understand, speak, and read English
* Provide signed informed consent and agree to comply with all protocol-specified procedures (e.g., providing saliva samples, participating in five one-hour group sessions over a period of 22 days) and follow-up evaluations
Exclusion Criteria:
* Chews betel nut without tobacco
* Does not speak, read, and/or write English
* Women who are pregnant or nursing
* Psychiatric illness/social situations that would limit compliance with study requirements
* Other illness that in the opinion of the investigator would exclude the patient from participating in this study
References
Publications (70)
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Change in number of participants who self-report that they quit chewing betel nut to be measured via survey
timeFrame
22 days
description
This will measure cessation prevalence immediately after the program
measure
Change in number of participants who self-report that they quit chewing betel nut to be measured via survey
timeFrame
6 months
description
This will measure cessation prevalence (stay-quit) long-term
Secondary outcomes (2)
measure
Levels of cotinine and betel nut biomarkers in saliva samples to be tested via liquid chromatography mass spectrometry
timeFrame
22 days
description
Cut-off levels for betel nut biomarkers include arecoline (60 ng/mL), arecaidine (10 ng/mL), guvacoline (20 ng/mL), and guvacine (6 ng/mL).
measure
Levels of cotinine and betel nut biomarkers in saliva samples to be tested via liquid chromatography mass spectrometry
timeFrame
6 months
description
Cut-off levels for betel nut biomarkers include arecoline (60 ng/mL), arecaidine (10 ng/mL), guvacoline (20 ng/mL), and guvacine (6 ng/mL).
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DERIVEDRojas GA, Erari S, Paulino YC, Herzog TA. Facilitator experiences and lessons learned from the Betel nut intervention trial (BENIT). BMC Public Health. 2024 Jan 24;24(1):288. doi: 10.1186/s12889-024-17788-4. PMID 38267890
DERIVEDHerzog TA, Wilkens LR, Badowski G, Mendez AJP, Franke AA, Pokhrel P, Chennaux JSN, Tenorio LF, Sotto PP, Kawamoto CT, Paulino YC. The Betel Nut Intervention Trial (BENIT)-A Randomized Clinical Trial for Areca Nut and Betel Quid Cessation: Primary Outcomes. Int J Environ Res Public Health. 2023 Aug 21;20(16):6622. doi: 10.3390/ijerph20166622. PMID 37623205