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临床试验/NCT06801860
NCT06801860已完成不适用

The Effectiveness of Chewing Gum for Reducing Cigarette Consumption and Promoting Smoking Cessation: A Pilot Randomized Controlled Trial

The University of Hong Kong1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年2月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
1
主要终点
Validated abstinence

研究概览

简要总结

The goal of this trial is to assess the feasibility, acceptability, and preliminary effectiveness of chewing gum to reduce cigarette consumption and promote smoking cessation. The main questions it aims to answer are: Do participants in the intervention group report a higher reduction in cigarette consumption, improved smoking cessation outcomes, and healthier oral health than the control group?

Researchers will compare chewing gum intervention to unassisted quitting to see if chewing gum works to cigarette reduction and smoking cessation.

Participants will:

  1. Receive very brief smoking cessation advice and booklet at baseline.
  2. Take chewing gum or unassisted quitting for 1 week.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Residents of Hong Kong aged 18 or above
  • •Smoking at least 1 cigarette per day over the past 3 months
  • •Have the habit of chewing gum or are willing to use chewing gum
  • •Participants who can communicate in Cantonese (including reading Chinese)
  • •Expressing an intention to quit or reduce smoking
  • •Capable of using instant messaging tools (e.g., WhatsApp, WeChat) for communication

排除标准

  • •Having communication barriers (either physical or cognitive)
  • •Currently participating in other smoking cessation programs or services

研究组 & 干预措施

Chewing gum

Experimental

Participants in the intervention group will receive 1-2 packs of chewing gum over a 1-week intervention period. They will also receive a leaflet of usage tips for chewing gum, including 1) the potential benefits of chewing gum, 2) suitable usage time and dosage, and 3) the proper disposal of used gum.Additionally, participants in the intervention group will receive 2-week reminder message to boost gum usage.

干预措施: Very brief smoking cessation advice (Behavioral)

Chewing gum

Experimental

Participants in the intervention group will receive 1-2 packs of chewing gum over a 1-week intervention period. They will also receive a leaflet of usage tips for chewing gum, including 1) the potential benefits of chewing gum, 2) suitable usage time and dosage, and 3) the proper disposal of used gum.Additionally, participants in the intervention group will receive 2-week reminder message to boost gum usage.

干预措施: Chewing gum (Behavioral)

Chewing gum

Experimental

Participants in the intervention group will receive 1-2 packs of chewing gum over a 1-week intervention period. They will also receive a leaflet of usage tips for chewing gum, including 1) the potential benefits of chewing gum, 2) suitable usage time and dosage, and 3) the proper disposal of used gum.Additionally, participants in the intervention group will receive 2-week reminder message to boost gum usage.

干预措施: Chewing gum usage leaflet (Behavioral)

Chewing gum

Experimental

Participants in the intervention group will receive 1-2 packs of chewing gum over a 1-week intervention period. They will also receive a leaflet of usage tips for chewing gum, including 1) the potential benefits of chewing gum, 2) suitable usage time and dosage, and 3) the proper disposal of used gum.Additionally, participants in the intervention group will receive 2-week reminder message to boost gum usage.

干预措施: 2-week reminder message (Behavioral)

Unassisted quitting

Active Comparator

Participants in the unassisted quitting group (control group) will receive very brief smoking cessation advice (30 seconds) and a smoking cessation information booklet at baseline.

干预措施: Very brief smoking cessation advice (Behavioral)

结局指标

主要结局

Validated abstinence

时间窗: 6-month follow-up

Biochemically validated smoking abstinence will be measured by saliva cotinine level (exhaled carbon monoxide \<4 ppm and salivary cotinine \<30 ng/ml)

次要结局

  • Number of pieces used(2-week, 3-month, and 6-month follow-ups)
  • Frequency of use(2-week, 3-month, and 6-month follow-ups)
  • Duration of use(2-week, 3-month, and 6-month follow-ups)
  • Health effect(2-week, 3-month, and 6-month follow-ups)
  • The biochemically validated smoking abstinence(6-month follow-up)
  • Self-reported 7-day point-prevalence abstinence(2-week, 3-month, and 6-month)
  • Self-reported smoking change(2-week, 3-month, and 6-month follow-ups)
  • Self-reported self-efficacy of quitting(2-week, 3-month, and 6-month follow-ups)
  • Self-reported quit attempt(2-week, 3-month, and 6-month follow-ups)
  • Nicotine dependence level(2-week, 3-month, and 6-month follow-ups)
  • Smoking cessation services use(2-week, 3-month, and 6-month follow-ups)
  • Self-reported intention to quit(2-week, 3-month, and 6-month follow-ups)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Wang Man-Ping

Professor

The University of Hong Kong

研究点 (1)

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