Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02942745
Other study ID # 2U54CA143728
Secondary ID 2U54CA143728
Status Completed
Phase N/A
First received
Last updated
Start date August 2016
Est. completion date August 31, 2020

Study information

Verified date November 2019
Source University of Guam
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

The general framework employed to guide the intervention is cognitive-behavioral therapy. The cognitive-behavioral therapy is goal-oriented and problem-focused. The goal of the intervention is to help betel nut chewers to quit chewing betel nut using structured sessions. The cognitive component addresses chewers' attitudes and beliefs about betel nut chewing. Preliminary data from a feasibility study revealed that most participants initially underestimated such negative health effects of betel nut. The behavioral component of the intervention aims to replace chewing-promoting behaviors with behaviors that are more conducive to quitting betel nut and staying quit, and preparing responses for social situations where pressure to chew is likely to occur.

The structure of the proposed betel nut cessation program is modeled after a specific group-based cognitive-behavioral smoking cessation program. The program was selected because it is a well-established and evidence-based group cessation program. The intervention will consist of a 22-day, five-session support and informational group program. Betel nut use will be evaluated via surveys and bio-verification at three points: at the initial group meeting, at the final group meeting, and six months following the final group meeting.

Group Intervention Format and Procedures

Five group sessions will be conducted over a period of 22 days per cohort. Group meetings will be approximately one hour in length and will be conducted by study investigators and staff. Surveys will be administered at the first and last group meetings, as well as six months after the last meeting. Surveys will be self-administered at the beginning of the intervention sessions. Confidentiality will be emphasized at all meetings, but especially so in the first session, and will be addressed specifically in the informed consent document. Participants will be reminded that participation is completely voluntary and that withdrawal without penalty is always an option. At most sessions, handouts will be provided and topical "homework" will be distributed.

Saliva Samples

Saliva samples (ca. 1-2 mL) for intervention condition participants will be collected at the same times as the three survey assessments (baseline, the final group intervention session, and the six-month follow-up). Saliva samples for control condition participants (also ca. 1-2 mL) will be collected on the same schedule as the intervention condition participants. From the saliva samples, Dr. Adrian Franke's laboratory will measure by liquid chromatography mass spectrometry levels of salivary biomarkers previously identified in the pilot study, which identified compounds specific for areca nuts and betel leaves that were extracted while chewing three different betel preparations. The studies also revealed that the compounds are secreted into saliva and appear in chewers' saliva up to eight hours after the chewing event. To verify self-reports of betel nut abstinence, the investigators will set cut-offs for levels of alkaloids specific for areca nuts as follows: arecoline 60 ng/mL, arecaidine 10 ng/mL, guvacoline 20 ng/mL, and guvacine 6 ng/mL). Levels above the values will indicate evidence of recent betel nut consumption. Participants whose saliva tests reveal values above the specified cut-offs will be considered current chewers for the purposes of bio-verified outcomes (i.e., chewer or non-chewer status). The biomarker results will be used to compare self-reports of recent chewing behavior (amount and recency) with biomarker data to assess dose-response effects.

Saliva samples will be collected in Guam and Saipan in 20 mL conical polypropylene tubes which will be initially stored at -20°C. Aggregated samples will be shipped to Hawaii via FedEx. Shipments will be performed whenever 50-60 samples are successfully collected. After arriving in Hawaii, samples will be stored in Dr. Adrian Franke's lab at -80°C until analysis. All samples available at Dr. Adrian Franke's lab will be analyzed in one batch at the end of each annual cycle of the study.

Survey Assessments

Baseline Survey

The baseline survey will be administered during the first group session. Saliva samples will be collected.

First Follow-Up Survey

The first follow-up survey will be administered during the final group session. Participants will indicate any attempt to quit chewing betel nut since starting the intervention program, current chewing status (chewer or ex-chewer), number of group sessions attended (and reasons for absence, if applicable), and quid composition (if still chewing). The participants will also be asked several questions to measure satisfaction with the cessation program. Saliva samples will be collected for a second time.

Second Follow-Up Survey

Six months post-cessation, participants will arrange to meet with study staff to complete a final survey assessment. Participants will be asked again to evaluate the program, as well as follow-up questions regarding current chewing status and betel quid composition. Saliva samples will be collected for a final time.

Measurement of Cessation Outcomes

Primary cessation outcomes will be assessed by self-reported 7-day point prevalence abstinence bio-verified by the saliva tests. Participants who self-report chewing cessation but who test positive for the betel nut biomarker will be classified as chewers.

Data Analysis

The data analysis plan was designed under the direct guidance of the U54 Biostatistics Core. The goal of the analysis is to determine if the proposed intervention strategy affects cessation of betel nut chewing. Information on chewing behavior will be collected at baseline, month 1, and month 6 for the intervention (IN0, IN1, IN6) and control conditions (C0, C1, C6). The efficacy of the cessation program will be assessed by estimation and comparison of cessation prevalence over time, defined as the proportion who are not chewing betel nut. The first test of efficacy will compare the cessation status between randomization groups at month 1 and month 6, using a logistic mixed model, which will account for the repeated (correlated) measures within each individual. The independent variables will include randomization group (defined as intent-to- treat), time (parameterized as two indicator variables), location (Guam/Saipan), and interaction terms between group and time. Potential confounders, such as gender, ethnicity and age, will be added to the models. The F-test for the interaction term for 6 months will be the test of efficacy. Statistics of interest from the model include the odds ratio and 95% confidence interval (CI) comparing randomization groups, and the covariate-adjusted probabilities of cessation and their 95% CIs, predicted by group from the model. The data will be analyzed within subgroups, such as location (Guam or Saipan) to provide information on whether the intervention was more effective in select groups. The investigators will model treatment as the number of sessions attended to determine if the program was more effective in more compliant participants. The mixed model uses all available data points at each time point. If there is evidence of non-random missingness, such as by differential drop-out between groups, multiple imputation will be used to determine if missing data led to biased results.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Betel Nut Cessation Social Support
The cessation sessions will be led by trained facilitators over 22-day period. Session 1 (Day 1) includes a discussion of health risks associated with betel nut chewing, and introduction to self-monitoring and triggers logs. Session 2 (Day 8) includes a review of their logs, and discussions of lifestyle changes to assist cessation of betel nut chewing. Session 3 (Day 15) will be the quit day for chewers. Coping mechanisms and plans to maximize social support will be discussed. Session 4 (Day 18) will focus on quitting experiences. Facilitators will also review the negative health effects when wanting to chew again. Discussion on quitting experiences will continue in Session 5 (Day 22). Facilitators will also address those who have experienced relapse, and how to manage relapse.
Betel Nut Cessation Booklet
Participants will receive minimal intervention via a single booklet that contains all the information offered in the experimental group, minus the social support sessions. The participants will meet with study staff individually at a designated office in Guam or Saipan to receive the betel nut cessation booklet, complete three assessments (baseline, 22 days, 6 months), and provide saliva samples.

Locations

Country Name City State
Guam University of Guam Mangilao Village

Sponsors (3)

Lead Sponsor Collaborator
University of Guam National Cancer Institute (NCI), University of Hawaii Cancer Research Center

Country where clinical trial is conducted

Guam, 

References & Publications (68)

33. Fiore M, Jaen CR, Baker TB, Bailey WC, Benowitz NL, Curry SJ, Dorfman SF, Froelicher ES, Goldstein MG, Healton CG, Henderson PN, Heyman RB, Koh HK, Kottke TE, Lando HA, Mecklenburg RE, Mermelstein RJ, Mullen PD, Orleans CT, Robinson L, Stitzer ML, Tommasello AC, Villejo L, Wewers ME. Treating Tobacco Use and Dependence: 2008 Update. Clinical Practice Guideline. 2008 update ed. Rockville, Md.: U.S. Dept. of Health and Human Services, Public Health Service; 2008. xvii, 256 p. p.

American Psychiatric Association. Diagnostic and statistical manual of mental disorders : DSM-IV-TR. 4th ed. Washington, DC: American Psychiatric Association; 2000. xxxvii, 943 p. p.

Benegal V, Rajkumar RP, Muralidharan K. Does areca nut use lead to dependence? Drug Alcohol Depend. 2008 Sep 1;97(1-2):114-21. doi: 10.1016/j.drugalcdep.2008.03.016. Epub 2008 May 19. — View Citation

Berlin I, Singleton EG, Pedarriosse AM, Lancrenon S, Rames A, Aubin HJ, Niaura R. The Modified Reasons for Smoking Scale: factorial structure, gender effects and relationship with nicotine dependence and smoking cessation in French smokers. Addiction. 2003 Nov;98(11):1575-83. — View Citation

Bhat SJ, Blank MD, Balster RL, Nichter M, Nichter M. Areca nut dependence among chewers in a South Indian community who do not also use tobacco. Addiction. 2010 Jul;105(7):1303-10. doi: 10.1111/j.1360-0443.2010.02952.x. — View Citation

Borrelli B. The assessment, monitoring, and enhancement of treatment fidelity in public health clinical trials. J Public Health Dent. 2011 Winter;71 Suppl 1:S52-63. — View Citation

Boucher BJ, Mannan N. Metabolic effects of the consumption of Areca catechu. Addict Biol. 2002 Jan;7(1):103-10. Review. — View Citation

Boyle RG, Enstad C, Asche SE, Thoele MJ, Sherwood NE, Severson HH, Ebbert J, Solberg LI. A randomized controlled trial of Telephone Counseling with smokeless tobacco users: the ChewFree Minnesota study. Nicotine Tob Res. 2008 Sep;10(9):1433-40. doi: 10.10 — View Citation

Brandon TH, Baker TB. The Smoking Consequences Questionnaire: the subjective expected utility of smoking in college students. Psychological Assessment. 1991;3:484-91.

Brown RA. Intensive behavioral treatment. In: Abrams DB, editor. The tobacco dependence treatment handbook : a guide to best practices. New York: Guilford Press; 2003. p. 118-77.

Brown, R. A. (2003). Intensive behavioral treatment. In D. B. Abrams (Ed.), The tobacco dependence treatment handbook : a guide to best practices (pp. 118-177). New York: Guilford Press.

Chandra PS, Carey MP, Carey KB, Jairam KR. Prevalence and correlates of areca nut use among psychiatric patients in India. Drug Alcohol Depend. 2003 Apr 1;69(3):311-6. — View Citation

Chu NS. Neurological aspects of areca and betel chewing. Addict Biol. 2002 Jan;7(1):111-4. Review. — View Citation

Cohen J. Statistical power analysis for the behavioral sciences. 2nd ed. Hillsdale, N.J.: L. Erlbaum Associates; 1988. xxi, 567 p. p.

Franke AA, Lai JF, Kawamoto CT, Pokhrel P, Herzog TA. University of Hawai'i Cancer Center connection: Areca (betel) nut consumption: an underappreciated cause of cancer. Hawaii J Med Public Health. 2014 Dec;73(12):400-3. Review. — View Citation

Franke AA, Mendez AJ, Lai JF, Arat-Cabading C, Li X, Custer LJ. Composition of betel specific chemicals in saliva during betel chewing for the identification of biomarkers. Food Chem Toxicol. 2015 Jun;80:241-246. doi: 10.1016/j.fct.2015.03.012. Epub 2015 Mar 19. — View Citation

Franke AA, Morimoto Y, Yeh LM, Maskarinec G. Urinary isoflavonoids as a dietary compliance measure among premenopausal women. Asia Pac J Clin Nutr. 2006;15(1):88-94. — View Citation

Friedman LM, Furberg C, DeMets DL. Fundamentals of clinical trials. 3rd ed. New York: Springer; 1998. xviii, 361 p. p.

Ghani WM, Razak IA, Yang YH, Talib NA, Ikeda N, Axell T, Gupta PC, Handa Y, Abdullah N, Zain RB. Factors affecting commencement and cessation of betel quid chewing behaviour in Malaysian adults. BMC Public Health. 2011 Feb 7;11:82. doi: 10.1186/1471-2458-11-82. — View Citation

Glover E, Wang M, WGlover P. Development of a high school smokeless tobacco cessation manual. Health Values: The Journal of Health Behavior, Education & Promotion. 1994;18(2):1-7.

Gupta B, Johnson NW. Systematic review and meta-analysis of association of smokeless tobacco and of betel quid without tobacco with incidence of oral cancer in South Asia and the Pacific. PLoS One. 2014 Nov 20;9(11):e113385. doi: 10.1371/journal.pone.0113385. eCollection 2014. Review. — View Citation

Gupta PC, Ray CS. Epidemiology of betel quid usage. Ann Acad Med Singap. 2004 Jul;33(4 Suppl):31-6. Review. — View Citation

Gupta PC, Warnakulasuriya S. Global epidemiology of areca nut usage. Addict Biol. 2002 Jan;7(1):77-83. — View Citation

Haddock RL, Whippy HJ, Talon RJ, Montano MV. Ethnic disparities in cancer incidence among residents of Guam. Asian Pac J Cancer Prev. 2009 Jan-Mar;10(1):57-62. — View Citation

Haddock RL. Oral cancer incidence disparity among ethnic groups on Guam. Pac Health Dialog. 2005 Mar;12(1):153-4. — View Citation

Herzog TA, Murphy KL, Little MA, Suguitan GS, Pokhrel P, Kawamoto CT. The Betel Quid Dependence Scale: replication and extension in a Guamanian sample. Drug Alcohol Depend. 2014 May 1;138:154-60. doi: 10.1016/j.drugalcdep.2014.02.022. Epub 2014 Feb 26. — View Citation

Herzog TA, Pokhrel P. Ethnic differences in smoking rate, nicotine dependence, and cessation-related variables among adult smokers in Hawaii. J Community Health. 2012 Dec;37(6):1226-33. doi: 10.1007/s10900-012-9558-8. — View Citation

Herzog TA. Analyzing the transtheoretical model using the framework of Weinstein, Rothman, and Sutton (1998): the example of smoking cessation. Health Psychol. 2008 Sep;27(5):548-56. doi: 10.1037/0278-6133.27.5.548. — View Citation

IARC Working Group on the Evaluation of Carcinogenic Risks to Humans. Betel-quid and areca-nut chewing and some areca-nut derived nitrosamines. IARC Monogr Eval Carcinog Risks Hum. 2004;85:1-334. — View Citation

IARC Working Group on the Evaluation of Carcinogenic Risks to Humans. Smokeless tobacco and some tobacco-specific N-nitrosamines. IARC Monogr Eval Carcinog Risks Hum. 2007;89:1-592. — View Citation

Jeng JH, Chang MC, Hahn LJ. Role of areca nut in betel quid-associated chemical carcinogenesis: current awareness and future perspectives. Oral Oncol. 2001 Sep;37(6):477-92. Review. — View Citation

Ko YC, Huang YL, Lee CH, Chen MJ, Lin LM, Tsai CC. Betel quid chewing, cigarette smoking and alcohol consumption related to oral cancer in Taiwan. J Oral Pathol Med. 1995 Nov;24(10):450-3. — View Citation

Le Marchand L, Hankin JH, Carter FS, Essling C, Luffey D, Franke AA, Wilkens LR, Cooney RV, Kolonel LN. A pilot study on the use of plasma carotenoids and ascorbic acid as markers of compliance to a high fruit and vegetable dietary intervention. Cancer Epidemiol Biomarkers Prev. 1994 Apr-May;3(3):245-51. — View Citation

Lee CH, Ko AM, Warnakulasuriya S, Ling TY, Sunarjo, Rajapakse PS, Zain RB, Ibrahim SO, Zhang SS, Wu HJ, Liu L, Kuntoro, Utomo B, Warusavithana SA, Razak IA, Abdullah N, Shrestha P, Shieh TY, Yen CF, Ko YC. Population burden of betel quid abuse and its relation to oral premalignant disorders in South, Southeast, and East Asia: an Asian Betel-quid Consortium Study. Am J Public Health. 2012 Mar;102(3):e17-24. doi: 10.2105/AJPH.2011.300521. Epub 2012 Jan 19. — View Citation

Lee CH, Ko YC, Huang HL, Chao YY, Tsai CC, Shieh TY, Lin LM. The precancer risk of betel quid chewing, tobacco use and alcohol consumption in oral leukoplakia and oral submucous fibrosis in southern Taiwan. Br J Cancer. 2003 Feb 10;88(3):366-72. — View Citation

Lee CY, Chang CS, Shieh TY, Chang YY. Development and validation of a self-rating scale for betel quid chewers based on a male-prisoner population in Taiwan: the Betel Quid Dependence Scale. Drug Alcohol Depend. 2012 Feb 1;121(1-2):18-22. doi: 10.1016/j.drugalcdep.2011.07.027. Epub 2011 Sep 28. — View Citation

Lin CF, Wang JD, Chen PH, Chang SJ, Yang YH, Ko YC. Predictors of betel quid chewing behavior and cessation patterns in Taiwan aborigines. BMC Public Health. 2006 Nov 3;6:271. — View Citation

Little MA, Pokhrel P, Murphy KL, Kawamoto CT, Suguitan GS, Herzog TA. Intention to quit betel quid: a comparison of betel quid chewers and cigarette smokers. Oral Health Dent Manag. 2014 Jun;13(2):512-8. — View Citation

Little MA, Pokhrel P, Murphy KL, Kawamoto CT, Suguitan GS, Herzog TA. The reasons for betel-quid chewing scale: assessment of factor structure, reliability, and validity. BMC Oral Health. 2014 Jun 3;14:62. doi: 10.1186/1472-6831-14-62. — View Citation

Little RJA, Rubin DB. Statistical analysis with missing data. New York: John Wiley & Sons; 2002.

Little, R. J. A., & Rubin, D. B. (2002). Statistical analysis with missing data. New York: John Wiley & Sons.

Mubeen K, Kumar CN, Puja R, Jigna VR, Chandrashekar H. Psychiatric morbidity among patients with oral sub-mucous fibrosis: a preliminary study. J Oral Pathol Med. 2010 Nov;39(10):761-4. doi: 10.1111/j.1600-0714.2010.00948.x. Epub 2010 Oct 4. — View Citation

Murti PR, Bhonsle RB, Pindborg JJ, Daftary DK, Gupta PC, Mehta FS. Malignant transformation rate in oral submucous fibrosis over a 17-year period. Community Dent Oral Epidemiol. 1985 Dec;13(6):340-1. — View Citation

Nair U, Bartsch H, Nair J. Alert for an epidemic of oral cancer due to use of the betel quid substitutes gutkha and pan masala: a review of agents and causative mechanisms. Mutagenesis. 2004 Jul;19(4):251-62. Review. — View Citation

Norton SA. Betel: consumption and consequences. J Am Acad Dermatol. 1998 Jan;38(1):81-8. Review. — View Citation

Oakley E, Demaine L, Warnakulasuriya S. Areca (betel) nut chewing habit among high-school children in the Commonwealth of the Northern Mariana Islands (Micronesia). Bull World Health Organ. 2005 Sep;83(9):656-60. Epub 2005 Sep 30. — View Citation

Paulino Y. Betel nut chewing in Micronesian populations. Achievement Rewards for College Scientists Selection Meeting; 2008; Honolulu, HI.

Paulino YC, Hurwitz EL, Warnakulasuriya S, Gatewood RR, Pierson KD, Tenorio LF, Novotny R, Palafox NA, Wilkens LR, Badowski G. Screening for oral potentially malignant disorders among areca (betel) nut chewers in Guam and Saipan. BMC Oral Health. 2014 Dec 11;14:151. doi: 10.1186/1472-6831-14-151. — View Citation

Paulino YC, Hurwitz EL, Wilkens LR, Novotny R, Miller MJ, Quinata KM. Pattern of areca (betel) nut chewing and obesity measures in Guam and Saipan, Mariana Islands. 20th International Epidemiologic Association World Congress of Epidemiology; 2014; Anchorage, AK.

Paulino YC, Hurwitz EL. Making the case for clearly defining tobacco use in areca (betel) nut chewers. American Public Health Association Annual Meeting; 2014; New Orleans, LA

Paulino YC, Novotny R, Miller MJ, Murphy SP. Areca (Betel) Nut Chewing Practices in Micronesian Populations. Hawaii J Public Health. 2011 Mar;3(1):19-29. — View Citation

Perkins KA, Conklin CA, Levine MD. Cognitive-behavioral therapy for smoking cessation : a practical guidebook to the most effective treatments. New York: Routledge; 2008. xxii, 258 p. p.

Pindborg JJ, Sirsat SM. Oral submucous fibrosis. Oral Surg Oral Med Oral Pathol. 1966 Dec;22(6):764-79. — View Citation

Piper ME, Piasecki TM, Federman EB, Bolt DM, Smith SS, Fiore MC, Baker TB. A multiple motives approach to tobacco dependence: the Wisconsin Inventory of Smoking Dependence Motives (WISDM-68). J Consult Clin Psychol. 2004 Apr;72(2):139-54. — View Citation

Secretan B, Straif K, Baan R, Grosse Y, El Ghissassi F, Bouvard V, Benbrahim-Tallaa L, Guha N, Freeman C, Galichet L, Cogliano V; WHO International Agency for Research on Cancer Monograph Working Group. A review of human carcinogens--Part E: tobacco, areca nut, alcohol, coal smoke, and salted fish. Lancet Oncol. 2009 Nov;10(11):1033-4. — View Citation

Shah SM, Merchant AT, Luby SP, Chotani RA. Addicted schoolchildren: prevalence and characteristics of areca nut chewers among primary school children in Karachi, Pakistan. J Paediatr Child Health. 2002 Oct;38(5):507-10. — View Citation

Stead LF, Lancaster T. Group behaviour therapy programmes for smoking cessation. Cochrane Database Syst Rev. 2005 Apr 18;(2):CD001007. Review. Update in: Cochrane Database Syst Rev. 2017 Mar 31;3:CD001007. — View Citation

Thomas S, Kearsley J. Betel quid and oral cancer: a review. Eur J Cancer B Oral Oncol. 1993 Oct;29B(4):251-5. Review. — View Citation

Uncangco AA, Badowski G, David AM, Ehlert MB, Haddock RL, Paulino YC. First Guam BRFSS Report 2017-2010. Mangilao, GU: 2012

Uncangco, A. A., Badowski, G., David, A. M., Ehlert, M. B., Haddock, R. L., & Paulino, Y. C. (2012). First Guam BRFSS Report 2017-2010. Retrieved from Mangilao, GU:

Walsh MM, Langer TJ, Kavanagh N, Mansell C, MacDougal W, Kavanagh C, Gansky SA. Smokeless tobacco cessation cluster randomized trial with rural high school males: intervention interaction with baseline smoking. Nicotine Tob Res. 2010 Jun;12(6):543-50. doi — View Citation

Warnakulasuriya S, & Peters T. Introduction: Biology, medical and socio-economic aspects of areca nut use. Addiction Biology, 7(1): 75-76, 2002.

Warnakulasuriya S. Areca nut use following migration and its consequences. Addict Biol. 2002 Jan;7(1):127-32. — View Citation

Wen CP, Tsai MK, Chung WS, Hsu HL, Chang YC, Chan HT, Chiang PH, Cheng TY, Tsai SP. Cancer risks from betel quid chewing beyond oral cancer: a multiple-site carcinogen when acting with smoking. Cancer Causes Control. 2010 Sep;21(9):1427-35. doi: 10.1007/s10552-010-9570-1. Epub 2010 May 11. — View Citation

Williams S, Arheart KL, WKiesges R. A smokeless tobacco cessation program for postsecondary students. Health Values: The Journal of Health Behavior, Education & Promotion. 1995;19(3):1-9.

Winstock A. Areca nut-abuse liability, dependence and public health. Addict Biol. 2002 Jan;7(1):133-8. — View Citation

World Health Organization. (2012). Review of areca (betel) nut and tobacco use in the Pacific: a technical report. Geneva: World Health Organization.

World Health Organization. The ICD-10 classification of mental and behavioural disorders : clinical descriptions and diagnostic guidelines. Geneva: World Health Organization; 1992. xii, 362 p. p.

* Note: There are 68 references in allClick here to view all references

Outcome

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
See also
  Status Clinical Trial Phase
Enrolling by invitation NCT05415371 - Persistent Poverty Counties Pregnant Women With Medicaid N/A
Not yet recruiting NCT04501016 - A Stepped Care Approach to Treating Tobacco Use in Rural Veterans Phase 2/Phase 3
Completed NCT01570595 - Positively Smoke Free on the Web (PSFW) for Smokers Living With HIV Phase 1/Phase 2
Completed NCT01651611 - Intervention Study to Increase Smoking Cessation Rates Among Public Housing Residents N/A
Completed NCT01099384 - Tobacco Cessation Treatment for Alaska Native Youth Phase 1
Completed NCT01164306 - The Impact of a Tobacco Control Intervention in African-American Families N/A
Recruiting NCT04865276 - Adaptation and Evaluation of a Culturally and Gender Relevant Tobacco Cessation Among Women in Brazil: An Integrated mHealth Approach N/A
Recruiting NCT02103868 - Medium Vs Low Intensity Intervention in Tobacco Cessation and Control in Zari Workers N/A
Completed NCT00836199 - NicVAX/Placebo as an Aid for Smoking Cessation Phase 3
Recruiting NCT05552534 - Impact of an Intervention of Screening, Treatment Initiation and Referral to PROmote Smoking CEssation in Emergency Department Patients N/A
Completed NCT01482923 - Tobacco Assessment and Intervention With Low-Income Persons Living With HIV-AIDS (PLWHA) in Community-Based AIDS Service Organizations
Completed NCT05764343 - The Effect of Immediate Smoking Cessation Interventions for Smokers With Chronic Airway Diseases N/A
Completed NCT01312480 - Adolescent Smoking Cessation in Pediatric Primary Care N/A
Completed NCT03377738 - Effectiveness of the Spirometry Test as a Motivational Tool for Quitting Tobacco in Primary Care N/A
Completed NCT03096145 - Support Person Intervention to Promote a Smoking Helpline Among Under Resourced Smokers N/A
Completed NCT05095779 - Incentives for Smoking Cessation in Persistent Poverty Counties N/A
Completed NCT03062709 - A Study of Tobacco Smoke and Children With Respiratory Illnesses N/A
Completed NCT00750503 - Workplace Tobacco Cessation And Oral Cancer Screening Study Phase 3
Withdrawn NCT04340102 - Development of a Scalable Intervention to Improve Smoking Cessation in Persons With Serious Mental Illness N/A
Completed NCT01331226 - Support Person Intervention to Promote a Smoking Helpline N/A