Interventions for Tobacco Dependent Adolescents
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Quit Rate; measured throughout study
研究概览
简要总结
Currently one in five high school students smoke. Smoking can harm adolescents well before they reach adulthood by causing a number of immediate, sometimes irreversible, health risks and problems. This study will examine whether reducing smoking will facilitate quitting smoking in adolescents who have unsuccessfully attempted to quit smoking
详细描述
Among adolescents, the short-term health effects of smoking include damage to the respiratory system, addiction to nicotine, and the associated risk of other drug use. Adolescents are at greater risk for long-term health problems, including several types of cancer. This study will examine whether reducing smoking will facilitate smoking cessation in adolescents who have unsuccessfully attempted to quit smoking. The study will also assess whether reduction of smoking leads to continued involvement in treatment, less toxic cigarette exposure, and improved motivation and self-efficacy to quit.
Participants in this open-label study will undergo 2 weeks of baseline measurements, followed by 2 weeks of smoking cessation treatment. Treatment will involve a nicotine patch, for those who are eligible, and a standardized behavioral intervention aimed at supporting smoking cessation. Those who are ineligible to receive a nicotine patch will only receive the standardized behavioral intervention. Participants who quit smoking during the first phase of treatment will continue to receive the nicotine patches and/or the standardized behavioral intervention. Those who are still smoking after the first treatment will be randomly assigned to one of two conditions and will continue to use nicotine patches for 4 weeks. Group 1 will receive standardized behavioral therapy and will set a specific quit date. Group 2 will be encouraged to decrease smoking by 50% the first week and 75% the second week. During Week 3, participants will be encouraged to completely quit smoking. Study visits will occur weekly, at which time nicotine patches will be dispensed, standardized behavioral therapy will be provided, and standard physiological measurements will be taken. A urine sample will also be collected. Follow-up visits will be held 2 weeks, 3 weeks, and 6 months following completion of the study.
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
- 13 Years 至 19 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Has smoked at least 5 cigarettes a day for at least 6 months
- •Does not regularly use other tobacco products
- •Motivated to quit smoking
- •Not currently using medications to quit smoking
- •Willing to use an effective form of contraception throughout the study
排除标准
- •Informed that nicotine replacement therapy is medically inadvisable
- •Diagnosed with a psychiatric disorder within 3 months prior to enrollment
- •Currently taking an unstable dose of psychoactive medications
- •Currently taking medications that may react with a nicotine patch
- •History of alcohol or drug abuse within 3 months prior to enrollment
研究组 & 干预措施
1
Usual care
干预措施: Usual Care (Drug)
2
Reduction in smoking
干预措施: Smoking Reduction (Other)
结局指标
主要结局
Quit Rate; measured throughout study
时间窗: 26 weeks
Extent of reduction in smoking; measured at Week 6
时间窗: 6, 12 and 26 weeks
次要结局
- Extent of exposure to cigarette toxicity; measured throughout study(6, 12 and 26 weeks)
- Degree of motivation to quit; measured at Week 6(6, 12 and 26 weeks)
