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临床试验/NCT00218270
NCT00218270已完成2 期

Treatment of Smokeless Tobacco Users

National Institute on Drug Abuse (NIDA)1 个研究点 分布在 1 个国家目标入组 138 人开始时间: 2002年12月最近更新:
适应症
干预措施
相关药物

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

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

Experimental

Reduction of tobacco use by substituting tobacco free snuff.

干预措施: Tobacco free snuff (Drug)

2

Placebo Comparator

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)

研究者

申办方类型
Nih

研究点 (1)

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