Treatment of Smokeless Tobacco Users
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- Percent reduction in use
研究概览
简要总结
Though spit tobacco is smokeless, it still affects the cardiovascular system and may be associated with heart disease, stroke, and high blood pressure. Long-term effects of smokeless tobacco (ST) include tooth abrasion, gum recession, mouth disease, loss of bone in the jaw, yellowing of teeth, and chronic bad breath. This study will assess the effectiveness of using tobacco free snuff in reducing levels of exposure to tobacco and associated toxicity, as well as enhancing motivation to either quit or sustain lower levels of nicotine intake.
详细描述
Spit tobacco presents as many health risks to its users as smoking tobacco. Although a significant number of ST users recognize the importance of quitting, many either do not want to quit or feel it is impossible. For these individuals, tobacco reduction may be an important transitional goal, either prior to quitting or as a treatment endpoint. However, approaches to help ST users reach this goal have not been studied. This study will assess the effectiveness of using tobacco-free snuff in reducing levels of exposure to tobacco and associated toxicity, as well as enhancing motivation to either quit or sustain lower levels of nicotine intake.
Participants will be randomly assigned to receive either treatment with tobacco-free snuff or treatment without it. All participants will be encouraged to reduce nicotine intake by 50% during the first four weeks and by 75% the following four weeks. Participants receiving the tobacco-free snuff will be asked to alternate the use of their usual brand of ST with tobacco-free snuff in order to achieve the targeted reduction. Participants not receiving the tobacco-free snuff will only be informed to try to cut down their tobacco use to the targeted reduction. Study visits will occur once weekly during the 8-week treatment period. Assessments will include vital signs, physiological measures related to tobacco use, and measures of motivation and self-efficacy to quit ST. The number of participants who either do not complete treatment, reduce nicotine intake, or quit completely will be assessed at the Week 8 study visit and at follow-up visits, which will be held at Weeks 12 and 26.
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 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Not interested in quitting smokeless tobacco use within 90 days of study entry
- •Used smokeless tobacco at least six times a day for 6 months prior to study entry
- •Agree to use an effective form of contraception throughout the study
排除标准
- •Current use of tobacco or nicotine products other than ST
- •Pregnant or breastfeeding
- •Any unstable medical condition
- •Use of any medication that may affect tobacco use or be affected by reduction of tobacco use
- •DSM-IV diagnosis of any psychiatric disorders or substance abuse disorders within 6 months prior to study entry
- •Use of any psychotropic medications within 6 months prior to study entry
研究组 & 干预措施
1
Reduction of tobacco use by substituting tobacco free snuff.
干预措施: Tobacco free snuff (Drug)
2
Reduction of tobacco use by using behavioral techniques.
干预措施: Tobacco free snuff (Drug)
结局指标
主要结局
Percent reduction in use
时间窗: Week 8, 12, and 26
Toxicity profile of carcinogen metabolites
时间窗: Week 8, 12, and 26
Abstinence (measured at Weeks 8, 12, and 26)
时间窗: Week 8, 12, and 26
Number of unsuccessful quit attempts
时间窗: Week 8, 12, and 26
次要结局
- Motivation and self-efficacy (measured at Weeks 8, 12, and 26)(Week 8, 12, and 26)
