Quit-Smoking Study for Native Hawaiians

Официальное название

Smoking Cessation Among Native Hawaiians: A Test of Pharmacotherapies and Group-Based Counseling

Обзор

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.

Вмешательства

• Препарат Nicotine Polacrilex Gum (2 mg)
  Participants chew 2 mg nicotine gum according to a tapering 12-week schedule: Weeks 1-6: 1 piece every 1-2 hours; at least 9 pieces/day; Weeks 7-9: 1 piece every 2-4 hours; Weeks 10-12: 1 piece every 4-8 hours. Max 24 pieces/day. Gum is distributed every 2 weeks during study visits. Arm(s) Used In: NRT Gum Only CBGT + NRT Gum
• Поведенческое Cognitive Behavioral Group Therapy (CBGT)
  Participants attend six sessions of group-based cognitive behavioral therapy focused on smoking cessation, over the 12-week study period. Sessions include education on cravings, relapse prevention, stress management, and self-efficacy building. Arm(s) Used In: CBGT Only CBGT + NRT Gum

Первичные конечные точки

• 7-day point prevalence abstinence (PPA) [Срок оценки: 12 weeks after baseline (Study Visit 8)]

Вторичные конечные точки (3)

• Change in nicotine dependence [Срок оценки: Baseline to 12 weeks]
• Change in smoking self-efficacy [Срок оценки: Baseline to 12 weeks]
• Number of adverse events [Срок оценки: Throughout the 12-week intervention period]

Критерии участия

Критерии включения

• Self-identifies as full or part Native Hawaiian
• Between the ages of 18 and 80 years, inclusive, at eligibility screening
• Currently smoking ≥5 cigarettes per day (self-report) at eligibility screening
• Has smoked more than 100 cigarettes in his/her lifetime (self-report)
• Affiliated with one of three (3) designated public housing complexes at which the intervention will be delivered: Kalihi Valley Homes, Kuhio Park Terrace, Mayor Wright Housing
• Willing to make a smoking cessation attempt the day after the first study visit (i.e., date of consent)
• Willing to engage in use of nicotine replacement therapy gum (NRT gum) and/or smoking cessation-focused cognitive-behavioral group therapy (CBGT)
• Participant must agree to not use any form of pharmacotherapy (i.e., prescription medication or any form of nicotine replacement therapy) to try to quit smoking during the 12-week study period, except as specifically assigned to his or her study condition and distributed by the research team
• Participant must agree to not use other tobacco or nicotine products (e.g., cigars, little cigars, electronic cigarettes, nicotine pouches) during the 12-week study period
• Participant must agree to not smoke or vape cannabis (i.e., marijuana) during the 12- week study period
• Participant must agree to not use other illicit drugs, including prescription opioid medications, during the 12-week study period
• Participant must be able to speak, read, and write English
• Participant must be able to understand the study procedures and agree to participate in the study by providing written informed consent

Критерии исключения

• Pregnant or nursing, or planning to become pregnant or breastfeed in the next three (3) months
• Use of pharmacotherapy (i.e., prescription medication or any form of nicotine replacement therapy) to try to quit smoking in the 30 days prior to eligibility screening
• Use of other tobacco or nicotine products (e.g., cigars, little cigars, electronic cigarettes, nicotine pouches) in the 30 days prior to eligibility screening
• Use of smoked or vaped cannabis (i.e., marijuana) in the 30 days prior to eligibility screening
• Use of other illicit drugs, including prescription opioid medications, in the 30 days prior to eligibility screening

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Hawai'i — Honolulu

Публикации

• 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. PMID 26092476
• 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. PMID 20099947
• 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. PMID 28361497
• 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. PMID 27658756
• 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. PMID 18374742
• 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. PMID 10165099
• 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. PMID 21414733
• 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. PMID 30797382

Идентификаторы

NCT: NCT07075575 · POKHREL-2024-1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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