drugset / Trial / NCT07075575
Quit-Smoking Study for Native Hawaiians
RandomizedParallel-groupOpen-labelTreatment
Summary
This study aims to help Native Hawaiian adults quit smoking by testing two common methods: nicotine gum and group-based counseling. Participants will be assigned to one of three groups: (1) nicotine gum only, (2) group counseling only, or (3) a combination of both. The study will take place at public housing sites on O'ahu. Researchers will check if these approaches-alone or in combination-can support people in successfully quitting smoking. The goal is to find out which method works best and is most acceptable in this community.
Timeline
- Start
- 2026-04-01
- Primary completion
- 2027-11-01
- Completion
- 2028-04-01
Publications
- Results Whitehead AL, Julious SA, Cooper CL, Campbell MJ. Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable. Stat Methods Med Res. 2016 Jun;25(3):1057-73. doi: 10.1177/0962280215588241. Epub 2015 Jun 19.
- Results Webb MS, de Ybarra DR, Baker EA, Reis IM, Carey MP. Cognitive-behavioral therapy to promote smoking cessation among African American smokers: a randomized clinical trial. J Consult Clin Psychol. 2010 Feb;78(1):24-33. doi: 10.1037/a0017669.
- Results Stead LF, Carroll AJ, Lancaster T. Group behaviour therapy programmes for smoking cessation. Cochrane Database Syst Rev. 2017 Mar 31;3(3):CD001007. doi: 10.1002/14651858.CD001007.pub3.
- Results Rohsenow DJ, Martin RA, Tidey JW, Colby SM, Monti PM. Treating Smokers in Substance Treatment With Contingent Vouchers, Nicotine Replacement and Brief Advice Adapted for Sobriety Settings. J Subst Abuse Treat. 2017 Jan;72:72-79. doi: 10.1016/j.jsat.2016.08.012. Epub 2016 Aug 18.
- Results Ong JC, Kuo TF, Manber R. Who is at risk for dropout from group cognitive-behavior therapy for insomnia? J Psychosom Res. 2008 Apr;64(4):419-25. doi: 10.1016/j.jpsychores.2007.10.009.
- Results Nevid JS, Javier RA. Preliminary investigation of a culturally specific smoking cessation intervention for Hispanic smokers. Am J Health Promot. 1997 Jan-Feb;11(3):198-207. doi: 10.4278/0890-1171-11.3.198.
- Results Meredith SE, Grabinski MJ, Dallery J. Internet-based group contingency management to promote abstinence from cigarette smoking: a feasibility study. Drug Alcohol Depend. 2011 Oct 1;118(1):23-30. doi: 10.1016/j.drugalcdep.2011.02.012. Epub 2011 Mar 16.
- Results Lo Coco G, Melchiori F, Oieni V, Infurna MR, Strauss B, Schwartze D, Rosendahl J, Gullo S. Group treatment for substance use disorder in adults: A systematic review and meta-analysis of randomized-controlled trials. J Subst Abuse Treat. 2019 Apr;99:104-116. doi: 10.1016/j.jsat.2019.01.016. Epub 2019 Jan 24.
- Results Lee PN, Fariss MW. A systematic review of possible serious adverse health effects of nicotine replacement therapy. Arch Toxicol. 2017 Apr;91(4):1565-1594. doi: 10.1007/s00204-016-1856-y. Epub 2016 Oct 3.
- Results Lancaster T, Stead LF. Individual behavioural counselling for smoking cessation. Cochrane Database Syst Rev. 2017 Mar 31;3(3):CD001292. doi: 10.1002/14651858.CD001292.pub3.
- Results Hunt DF, Bailey J, Lennox BR, Crofts M, Vincent C. Enhancing psychological safety in mental health services. Int J Ment Health Syst. 2021 Apr 14;15(1):33. doi: 10.1186/s13033-021-00439-1.
- Results Hiscock R, Murray S, Brose LS, McEwen A, Bee JL, Dobbie F, Bauld L. Behavioural therapy for smoking cessation: the effectiveness of different intervention types for disadvantaged and affluent smokers. Addict Behav. 2013 Nov;38(11):2787-96. doi: 10.1016/j.addbeh.2013.07.010. Epub 2013 Jul 21.
- Results Goldstein AO, Gans SP, Ripley-Moffitt C, Kotsen C, Bars M. Use of Expired Air Carbon Monoxide Testing in Clinical Tobacco Treatment Settings. Chest. 2018 Feb;153(2):554-562. doi: 10.1016/j.chest.2017.11.002. Epub 2017 Nov 11.
- Results Gifford EV, Kohlenberg BS, Hayes SC, Pierson HM, Piasecki MP, Antonuccio DO, Palm KM. Does acceptance and relationship focused behavior therapy contribute to bupropion outcomes? A randomized controlled trial of functional analytic psychotherapy and acceptance and commitment therapy for smoking cessation. Behav Ther. 2011 Dec;42(4):700-15. doi: 10.1016/j.beth.2011.03.002. Epub 2011 May 25.
- Results Creamer MR, Wang TW, Babb S, Cullen KA, Day H, Willis G, Jamal A, Neff L. Tobacco Product Use and Cessation Indicators Among Adults - United States, 2018. MMWR Morb Mortal Wkly Rep. 2019 Nov 15;68(45):1013-1019. doi: 10.15585/mmwr.mm6845a2.
- Results Carter RE, Sonne SC, Brady KT. Practical considerations for estimating clinical trial accrual periods: application to a multi-center effectiveness study. BMC Med Res Methodol. 2005 Mar 30;5:11. doi: 10.1186/1471-2288-5-11.
- Results Babb S, Malarcher A, Schauer G, Asman K, Jamal A. Quitting Smoking Among Adults - United States, 2000-2015. MMWR Morb Mortal Wkly Rep. 2017 Jan 6;65(52):1457-1464. doi: 10.15585/mmwr.mm6552a1.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nicotine | Unknown | 2 mg | Oral |