Mindfulness Training Plus Oxytocin to Reduce Smoking and Craving Among Smokers in Withdrawal
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Smoking Lapse Analogue Task (delay score)
研究概览
简要总结
The purpose of this study is to examine the effects of mindfulness training and a drug called oxytocin on smoking.
详细描述
Mindfulness training allows individuals to be present with their own emotions, thoughts, and bodily sensations without reactive judgment, and will be given in the form of daily audio recordings. Oxytocin is a naturally occurring hormone in the brain and throughout the body. It is also an FDA-approved drug to help induce labor in pregnant women. In this study, the use oxytocin is experimental and is in the form of a nasal spray.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Smoke at least 10 cigarettes per day for the past year
排除标准
- •Current DSM-5 substance use disorder
- •Any medial condition that would increase risk for study participation
- •Women who are pregnant or nursing
- •Current use of psychiatric medication for anxiety or mood disorders
- •Planning to quit or reduce smoking in the next 30 days
- •Current regular use of other nicotine-containing products
- •Current mindfulness or mediation practice of greater than 5 minutes per day
研究组 & 干预措施
Mindfulness and intranasal oxytocin
Given oxytocin through intranasal administration and self-directed mindfulness training.
干预措施: Oxytocin (Drug)
Mindfulness and intranasal oxytocin
Given oxytocin through intranasal administration and self-directed mindfulness training.
干预措施: Mindfulness (Behavioral)
Mindfulness and placebo
Given sterile saline through intranasal adminstration and self-directed mindfulness training.
干预措施: Mindfulness (Behavioral)
Mindfulness and placebo
Given sterile saline through intranasal adminstration and self-directed mindfulness training.
干预措施: Saline Solution (Drug)
Sham mindfulness and placebo
Given sterile saline through intranasal adminstration and sham self-directed mindfulness training.
干预措施: Saline Solution (Drug)
Sham mindfulness and placebo
Given sterile saline through intranasal adminstration and sham self-directed mindfulness training.
干预措施: Sham mindfulness (Behavioral)
结局指标
主要结局
Smoking Lapse Analogue Task (delay score)
时间窗: 2 hours after nasal spray administration
This task measures ability to resist the temptation to initiate smoking under conditions in which it is advantageous to remain abstinent. The "delay score" is the number of minutes before participants begin smoking (0-50 min).
Trier Social Stress Test
时间窗: 1 hour after nasal spray administration
This test measures self-reported responses to stress in a lab setting over the course of 30 minutes through salivary cortisol and heart rate variability.
次要结局
- Systolic blood pressure(Throughout study completion, an average of two weeks.)
- Diastolic blood pressure(Throughout study completion, an average of two weeks.)
- Heart rate(Throughout study completion, an average of two weeks.)
研究者
David Black
Associate Professor
University of Southern California