Development of a Mobile Health Intervention for Electronic Cigarette Use Among Young Adults
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- ENDS cessation
研究概览
简要总结
Electronic Nicotine Delivery Systems (ENDS) use remains prevalent among young adults, and many have high interest in quitting, yet research on effective intervention is lacking. A mobile health (mHealth) intervention that translates effective smoking cessation materials and pharmacotherapy may be a promising avenue for intervention. The initial phase of the proposed study uses a pilot study to evaluate a novel mHealth intervention for young adult ENDS and dual product (ENDS and combustible cigarette) users.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 26 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-26 years old, ability to understand the English language, willing and able to provide informed consent
- •Current ENDS user (at least 4 out of 7 days per week of use for the past one month); for focus groups, at least half of participants will report current cigarette smoking (at least 1 cigarette per day on at least 1 day per week in the past month)
- •Report interest in quitting or reducing ENDS (at least 6/10 scale in interest of quitting or reducing
- •Does not currently (in past one year) meet criteria for major psychiatric disorder including severe alcohol or substance use disorder (excluding tobacco use disorder), schizophrenia, bipolar disorder, and obsessive compulsive disorder
- •For women, not currently pregnant, planning to become pregnant, or breastfeeding due to lack of information on ENDS use and possible harms from NRT during pregnancy
- •Not currently using smoking cessation medication (i.e., Varenicline, Bupropion
- •No history of adverse reactions to nicotine replacement therapy
排除标准
- •Does not own a mobile phone or is unwilling to receive text messages to their device
- •No interest in quitting or reducing use of ENDS
- •Uses electronic cigarettes less than 4 days per week in the past month
- •Reports past-year serious psychiatric illness, including severe alcohol or substance use disorder (excluding tobacco use disorder), schizophrenia, bipolar disorder, and obsessive compulsive disorder
- •Is currently using smoking cessation medication including Varenicline or Bupropion
- •Are a female who is currently pregnant or nursing or planning to become pregnant within the next 6 months
研究组 & 干预措施
mobile health (mHealth)
Participants in this arm will receive a 6-week mHealth message based intervention through their smartphone. They will also have the option of requesting free nicotine replacement therapy (NRT) throughout the treatment period.
干预措施: EQUIP (Behavioral)
Standard care
Participants in this arm will receive a 5-10 minute walk-through of electronic nicotine delivery system (ENDS) and tobacco education and skills based on the most recent evidence. They will also have the options of requesting a sample of NRT.
干预措施: Standard Care (Behavioral)
结局指标
主要结局
ENDS cessation
时间窗: post-treatment (6 weeks) and at 6-week follow-up (week 12).
ENDS cessation will be measured using a modified Timeline Followback Interview using 7-day point prevalence abstinence with study staff and then confirmed via a mailed saliva cotinine test.
次要结局
- ENDS use(post-treatment (6 weeks) and at 6-week follow-up (week 12).)