Bio-Behavioral Predictors of the Efficacy of Nicotine Replacement Therapy - Transdisciplinary Tobacco Use Research Center (TTURC), Project 2
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 674
- 试验地点
- 1
- 主要终点
- Continuous Abstinence at End of Treatment (Self-report)(Defined as the Number of Consecutive Days Without Smoking a Cigarette for Each Subject)
研究概览
简要总结
The purpose of this research study is to:
- compare the effectiveness of a nicotine patch and nicotine nasal spray for smoking cessation; and
- identify predictors of response to these alternate forms of nicotine replacement therapy (NRT).
详细描述
The ultimate objective is to obtain information necessary to match NRT to those smokers with the greatest need and likelihood of benefit. The investigators hypothesize that the nicotine nasal spray (NS) will result in significantly higher abstinence rates than transdermal nicotine (TN) for the following subgroups of smokers: those with genotypes associated with less transmission of dopamine or serotonin, or greater metabolism of nicotine; and those with higher levels of novelty-seeking, depression, and attention deficit symptoms.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The subjects will be male and female smokers age 18-
- •Eligible smokers will be those currently smoking at least 10 cigarettes a day.
排除标准
- •Planning a pregnancy, pregnant, or lactating
- •Current addiction to opiates, cocaine, or stimulants
- •Skin allergies or chronic dermatitis (based on medical history/self-report)
- •An Axis 1 major psychiatric disorder
研究组 & 干预措施
Nicotine Nasal Spray
干预措施: Nicotine Nasal Spray (Drug)
Transdermal Nicotine patch
干预措施: Nicoderm Transdermal Patch (Drug)
结局指标
主要结局
Continuous Abstinence at End of Treatment (Self-report)(Defined as the Number of Consecutive Days Without Smoking a Cigarette for Each Subject)
时间窗: End of Treatment (8-weeks after quit date)
A self-report measure of continuous abstinence at end of treatment. It is defined as the number of consecutive days without smoking a cigarette for each subject, as determined by the Timeline Followback (TLFB), completed by research staff. The TLFB is an assessment tool that obtains estimates of daily smoking. Using a calendar, people provide retrospective estimates of their daily smoking over a specified time period that can vary up to 12 months from the interview date. The TLFB has also been used to assess other forms of substance abuse (e.g., alcohol, drugs, etc.).
次要结局
- Verified 7-day Point Prevalence Abstinence at End Of Treatment.(End of Treatment)