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Testing the Effectiveness of a Betel Nut Cessation Program (BENIT)

This study is currently recruiting participants.
See Contacts and Locations
Verified June 2017 by University of Guam
Sponsor:
Collaborators:
National Cancer Institute (NCI)
University of Hawaii Cancer Research Center
Information provided by (Responsible Party):
University of Guam
ClinicalTrials.gov Identifier:
NCT02942745
First received: September 22, 2016
Last updated: June 8, 2017
Last verified: June 2017
  Purpose

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.


Condition Intervention
Betel Nut Chewer Tobacco Cessation Behavioral: Betel Nut Cessation Social Support Behavioral: Other Betel Nut Cessation Booklet

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: NIH-NCI U54 University of Guam/Cancer Center of Hawaii Partnership Full Project II: The Betel Nut Intervention Trial

Further study details as provided by University of Guam:

Primary Outcome Measures:
  • Change in number of participants who self-report that they quit chewing betel nut to be measured via survey [ Time Frame: 22 days ]
    This will measure cessation prevalence immediately after the program

  • Change in number of participants who self-report that they quit chewing betel nut to be measured via survey [ Time Frame: 6 months ]
    This will measure cessation prevalence (stay-quit) long-term


Secondary Outcome Measures:
  • Levels of cotinine and betel nut biomarkers in saliva samples to be tested via liquid chromatography mass spectrometry [ Time Frame: 22 days ]
    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).

  • Levels of cotinine and betel nut biomarkers in saliva samples to be tested via liquid chromatography mass spectrometry [ Time Frame: 6 months ]
    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).


Estimated Enrollment: 324
Actual Study Start Date: August 2016
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Other: Betel Nut Cessation Booklet
The Other: Betel Nut Cessation Booklet Group will serve as the control group. 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.
Behavioral: Other Betel Nut Cessation Booklet
Betel Nut Cessation Booklet Group will serve as the control group. 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.
Experimental: 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.
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Self-described betel nut chewer (chewed betel nut for at least 3 years, and at a rate of at least 3 days per week). Must be Class 2 betel nut chewers: that is, must chew a quid consisting of areca nut, slaked lime, betel leaf, tobacco, and 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02942745

Contacts
Contact: Yvette C Paulino, PhD, CPH 671-735-2661 paulinoy@triton.uog.edu
Contact: Thaddeus A Herzog, PhD 808-441-7709 therzog@cc.hawaii.edu

Locations
Guam
University fo Guam Recruiting
Mangilao, Guam, 96923
Contact: John Peterson, PhD    671-735-3037    japeterson@fulbrightmail.org   
Sponsors and Collaborators
University of Guam
National Cancer Institute (NCI)
University of Hawaii Cancer Research Center
Investigators
Principal Investigator: Yvette C Paulino, PhD, CPH University of Guam, University of Hawaii
Principal Investigator: Thaddeus A Herzog, PhD University of Hawaii
  More Information

Publications:
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.
Little, R. J. A., & Rubin, D. B. (2002). Statistical analysis with missing data. New York: John Wiley & Sons.
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:
World Health Organization. (2012). Review of areca (betel) nut and tobacco use in the Pacific: a technical report. Geneva: World Health Organization.
Uncangco AA, Badowski G, David AM, Ehlert MB, Haddock RL, Paulino YC. First Guam BRFSS Report 2017-2010. Mangilao, GU: 2012
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.
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.
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.
Paulino Y. Betel nut chewing in Micronesian populations. Achievement Rewards for College Scientists Selection Meeting; 2008; Honolulu, HI.
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, 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.
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.
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.
Brandon TH, Baker TB. The Smoking Consequences Questionnaire: the subjective expected utility of smoking in college students. Psychological Assessment. 1991;3:484-91.
Friedman LM, Furberg C, DeMets DL. Fundamentals of clinical trials. 3rd ed. New York: Springer; 1998. xviii, 361 p. p.
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.
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.
Little RJA, Rubin DB. Statistical analysis with missing data. New York: John Wiley & Sons; 2002.
Cohen J. Statistical power analysis for the behavioral sciences. 2nd ed. Hillsdale, N.J.: L. Erlbaum Associates; 1988. xxi, 567 p. p.
Warnakulasuriya S, & Peters T. Introduction: Biology, medical and socio‐economic aspects of areca nut use. Addiction Biology, 7(1): 75-76, 2002.

Responsible Party: University of Guam
ClinicalTrials.gov Identifier: NCT02942745     History of Changes
Other Study ID Numbers: 2U54CA143728 ( U.S. NIH Grant/Contract )
Study First Received: September 22, 2016
Last Updated: June 8, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

ClinicalTrials.gov processed this record on July 21, 2017