A Pilot Trial Comparing NicoBloc to Nicotine Lozenges: Initial Acceptability and Feasibility Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- The Treatment Satisfaction Survey
研究概览
简要总结
To examine the feasibility, acceptability, and preliminary impact of using NicoBloc compared to nicotine lozenges
详细描述
Smoking remains the leading cause of preventable death in the U.S. with approximately 18% of the population continuing to smoke. However, smoking is concentrated in disadvantaged populations where the prevalence of smoking may be as high as 70-80 %. Participants will receive a sampling experience (use of nicotine lozenges or NicoBloc during sessions) with counseling focused around their experience of using these interventions, including side effects and smoking cessation expectancies.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older
- •planning to live in the Birmingham Metro area for the next 3 months
- •Smoking at least 5 cigarettes per day for the past year and a Carbon Monoxide>8ppm to ensure daily smoking. This relatively low cutoff was chosen due to the expectation of enrolling a large >50% African-American average <10 cigarettes per day compared to Whites who average ~15 cigarettes per day
- •exclusive use of filtered cigarettes
- •English speaking.
排除标准
- •Living in a restricted environment that does not allow smoking (e.g., prison or jail facility, etc.)
- •Pregnant or nursing (all women of childbearing potential will be required to use an acceptable form of contraception)
- •Currently enrolled in a smoking cessation treatment program, using nicotine replacement products, or prescribed bupropion or varenicline
- •Known allergy nicotine lozenge
- •Within one month post-myocardial infarction or untreated severe angina
- •Cognitive impairment or unstable psychiatric condition that interferes with the informed consent process (individuals stable on psychiatric medications will be included)
- •Daily or exclusive use of other tobacco products (e.g., electronic cigarettes, little cigars, etc.).
研究组 & 干预措施
NicoBloc
NicoBloc participants will be provided with NicoBloc to use during counseling sessions and will test smoking their conventional cigarette with NicoBloc.
干预措施: NicoBloc (Drug)
Nicotine Lozenge
Participants who receive nicotine lozenge will use the lozenge in session and will discuss the effects of using the lozenge in session.
干预措施: Nicotine Lozenge (Drug)
结局指标
主要结局
The Treatment Satisfaction Survey
时间窗: 4 months
* Number of items: 10 * Scale: 1 (not at all helpful) - 7 (very helpful), as well as "0" response for "Don't Know". * Full-scale range: 0-70 * Interpretation: Higher scores indicate more treatment satisfaction Subscales: N/A
次要结局
- Change in the Questionnaire of Smoking Urges-Brief Form, From Baseline to Week 4 Timepoint(Week 4)
- Retention Rates(4 months)
研究者
Karen Cropsey
Professor of Psychiatry
University of Alabama at Birmingham