Tobacco Cessation Clinical Trial
— BENITOfficial title:
NIH-NCI U54 University of Guam/Cancer Center of Hawaii Partnership Full Project II: The Betel Nut Intervention Trial
Verified date | November 2019 |
Source | University of Guam |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 276 |
Est. completion date | August 31, 2020 |
Est. primary completion date | August 31, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Guam | University of Guam | Mangilao Village |
Lead Sponsor | Collaborator |
---|---|
University of Guam | National Cancer Institute (NCI), University of Hawaii Cancer Research Center |
Guam,
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* Note: There are 68 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in number of participants who self-report that they quit chewing betel nut to be measured via survey | This will measure cessation prevalence immediately after the program | 22 days | |
Primary | Change in number of participants who self-report that they quit chewing betel nut to be measured via survey | This will measure cessation prevalence (stay-quit) long-term | 6 months | |
Secondary | Levels of cotinine and betel nut biomarkers in saliva samples to be tested via liquid chromatography mass spectrometry | 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). | 22 days | |
Secondary | Levels of cotinine and betel nut biomarkers in saliva samples to be tested via liquid chromatography mass spectrometry | 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). | 6 months |
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