Quit-Smoking Study for Native Hawaiians

Official title

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

Overview

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.

Interventions

• Drug 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
• Behavioral 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

Primary outcome measures

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

Secondary outcome measures (3)

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

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• University of Hawai'i — Honolulu

Publications

• 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

Identifiers

NCT: NCT07075575 · POKHREL-2024-1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗