Testing the Effectiveness of a Betel Nut Cessation Program

NCT02942745 | Completed

• 1 other identifier: 2U54CA143728
• Study Type: interventional
• Target: 276
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Betel Nut Chewer; Tobacco Cessation

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Levels of cotinine and betel nut biomarkers in saliva samples to be tested via liquid chromatography mass spectrometry

  22 days

• Levels of cotinine and betel nut biomarkers in saliva samples to be tested via liquid chromatography mass spectrometry

  6 months

Study Arms (2)

Control

PLACEBO COMPARATOR

Minimal interaction between participant and facilitator regarding cessation strategies. Participants will only be given a betel nut cessation booklet.

Behavioral: Betel Nut Cessation Booklet

Experimental

EXPERIMENTAL

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.

Behavioral: Betel Nut Cessation Social Support; Behavioral: Betel Nut Cessation Booklet

Interventions

Betel Nut Cessation Social Support BEHAVIORAL

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.

Experimental

Betel Nut Cessation Booklet BEHAVIORAL

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.

Control; Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Guam: lead
• National Cancer Institute (NCI): collaborator
• University of Hawaii Cancer Research Center: collaborator

Study Sites (1)

University of Guam

Mangilao Village, 96923, Guam

Location

Related Publications (70)

• 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.

  PMID: 18490113 BACKGROUND

• Chu NS. Neurological aspects of areca and betel chewing. Addict Biol. 2002 Jan;7(1):111-4. doi: 10.1080/13556210120091473.

  PMID: 11900630 BACKGROUND

• 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.

  PMID: 21294919 BACKGROUND

• 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.

  PMID: 25411778 BACKGROUND

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

  PMID: 15389304 BACKGROUND

• Gupta PC, Warnakulasuriya S. Global epidemiology of areca nut usage. Addict Biol. 2002 Jan;7(1):77-83. doi: 10.1080/13556210020091437.

  PMID: 11900626 BACKGROUND

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

  PMID: 18181481 BACKGROUND

• 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.

  PMID: 19469625 BACKGROUND

• 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.

  PMID: 24629627 BACKGROUND

• 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. No abstract available.

  PMID: 15635762 BACKGROUND

• 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. No abstract available.

  PMID: 18335640 BACKGROUND

• 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. doi: 10.1016/s1368-8375(01)00003-3.

  PMID: 11435174 BACKGROUND

• 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. doi: 10.1111/j.1600-0714.1995.tb01132.x.

  PMID: 8600280 BACKGROUND

• 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. doi: 10.1038/sj.bjc.6600727.

  PMID: 12569378 BACKGROUND

• 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.

  PMID: 24889863 BACKGROUND

• 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. doi: 10.1111/j.1600-0528.1985.tb00468.x.

  PMID: 3866655 BACKGROUND

• 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. doi: 10.1093/mutage/geh036.

  PMID: 15215323 BACKGROUND

• Norton SA. Betel: consumption and consequences. J Am Acad Dermatol. 1998 Jan;38(1):81-8. doi: 10.1016/s0190-9622(98)70543-2.

  PMID: 9448210 BACKGROUND

• 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.

  PMID: 25678943 BACKGROUND

• Pindborg JJ, Sirsat SM. Oral submucous fibrosis. Oral Surg Oral Med Oral Pathol. 1966 Dec;22(6):764-79. doi: 10.1016/0030-4220(66)90367-7. No abstract available.

  PMID: 5224185 BACKGROUND

• 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. doi: 10.1016/s1470-2045(09)70326-2. No abstract available.

  PMID: 19891056 BACKGROUND

• Thomas S, Kearsley J. Betel quid and oral cancer: a review. Eur J Cancer B Oral Oncol. 1993 Oct;29B(4):251-5. doi: 10.1016/0964-1955(93)90044-f. No abstract available.

  PMID: 11706417 BACKGROUND

• 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.

  PMID: 20458529 BACKGROUND

• 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.

  BACKGROUND

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

  BACKGROUND

• 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:

  BACKGROUND

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

  BACKGROUND

• Boucher BJ, Mannan N. Metabolic effects of the consumption of Areca catechu. Addict Biol. 2002 Jan;7(1):103-10. doi: 10.1080/13556210120091464.

  PMID: 11900629 BACKGROUND

• 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. doi: 10.1186/1471-2458-6-271.

  PMID: 17081309 BACKGROUND

• 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.

  PMID: 16211156 BACKGROUND

• 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. doi: 10.1046/j.1440-1754.2002.00040.x.

  PMID: 12354270 BACKGROUND

• Warnakulasuriya S. Areca nut use following migration and its consequences. Addict Biol. 2002 Jan;7(1):127-32. doi: 10.1080/13556210120091491.

  PMID: 11900632 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 22390524 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 18823181 BACKGROUND

• 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.

  PMID: 22438074 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

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

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 25495475 BACKGROUND

• 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.

  BACKGROUND

• 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. doi: 10.1016/s0376-8716(02)00329-0.

  PMID: 12633917 BACKGROUND

• 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.

  PMID: 20923447 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• Winstock A. Areca nut-abuse liability, dependence and public health. Addict Biol. 2002 Jan;7(1):133-8. doi: 10.1080/13556210120091509.

  PMID: 11900633 BACKGROUND

• 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.

  PMID: 20642513 BACKGROUND

• 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.

  PMID: 21955360 BACKGROUND

• 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. doi: 10.1046/j.1360-0443.2003.00523.x.

  PMID: 14616184 BACKGROUND

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

  BACKGROUND

• 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. doi: 10.1037/0022-006X.72.2.139.

  PMID: 15065950 BACKGROUND

• 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.

  PMID: 24984674 BACKGROUND

• 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.

  PMID: 16500883 BACKGROUND

• 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.

  PMID: 8019375 BACKGROUND

• 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.

  PMID: 25797484 BACKGROUND

• 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. No abstract available.

  PMID: 25628974 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 21656954 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• Stead LF, Lancaster T. Group behaviour therapy programmes for smoking cessation. Cochrane Database Syst Rev. 2005 Apr 18;(2):CD001007. doi: 10.1002/14651858.CD001007.pub2.

  PMID: 15846610 BACKGROUND

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

  BACKGROUND

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

  BACKGROUND

• Lord GA, Lim CK, Warnakulasuriya S, Peters TJ. Chemical and analytical aspects of areca nut. Addict Biol. 2002 Jan;7(1):99-102. doi: 10.1080/13556210120091455.

  PMID: 11900628 BACKGROUND

• 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: 10.1080/14622200802279872.

  PMID: 19023834 RESULT

• 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: 10.1093/ntr/ntq022. Epub 2010 May 3.

  PMID: 20439384 RESULT

• Rojas 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 DERIVED

• Herzog 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 DERIVED

MeSH Terms

Conditions

Tobacco Use Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Officials

• Yvette C Paulino, PhD, CPH

  University of Guam, University of Hawaii

  PRINCIPAL INVESTIGATOR

• Thaddeus A Herzog, PhD

  University of Hawaii

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2016
• First Posted: October 24, 2016
• Study Start: August 1, 2016
• Primary Completion: August 31, 2020
• Study Completion: August 31, 2020
• Last Updated: October 8, 2020

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

GU (1)