Oral Tobacco as a Harm Reduction Product: Study 2 - Efficacy of Oral Tobacco Products Compared to Medicinal Nicotine for Complete Cigarette Substitution and Among Non-abstainers, for Reduction in Cigarette Smoking
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 391
- 试验地点
- 2
- 主要终点
- Product Effect on Complete Substitution for Smoking
研究概览
简要总结
For the primary goals, we hypothesize that 1) the oral tobacco product will be more efficacious than the medicinal nicotine product in substituting for smoking cigarettes; 2) among non-abstainers, the oral tobacco product will lead to greater reduction in cigarette smoking than medicinal nicotine; and 3) a higher rate of oral tobacco compared to medicinal nicotine use will be observed during and beyond the treatment period.
For the secondary goals, we hypothesize that 1) both products will equally reduce withdrawal symptoms from cigarette abstinence; and 2) the toxicant exposure and toxicity will be reduced dramatically when smokers switch from cigarettes to each of these products; however, this reduction will be greater with the use of medicinal nicotine.
详细描述
This second study under "Oral Tobacco as a Harm Reduction Product" grant is a clinical trial. Subjects will be randomized to the brand of smokeless tobacco that is determined to be most effective in Study 1 or to nicotine gum for 12 weeks to compare complete substitution for smoking. The secondary aims are to determine the effects of the products on biomarkers of exposure and toxicity. Other secondary aim includes examining the effects of the two products on withdrawal symptoms. Two sites will be used for these studies: University of Minnesota and Oregon Research Institute (ORI).
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
盲法说明
This was an open label trial.
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
- •smoking at least 10 cigarettes daily for the past year,
- •in good physical health (no unstable medical condition;
- •no contraindications for medicinal nicotine, as appropriate for the study, stable, good mental health (e.g., no recent unstable or untreated psychiatric diagnosis, including substance abuse, as determined by the DSM-IV criteria).
排除标准
- •Subjects must not be currently using other tobacco or nicotine products; Female subjects cannot be pregnant or nursing.
研究组 & 干预措施
Nicotine Gum
Nicotine replacement therapy (4 mg nicotine gum) was provided to the participants for an 12 weeks. Participants were encouraged to completely substitute nicotine gum for cigarettes and asked to use at least 6-8 pieces a day or optimally every 1-2 h and more if necessary. They were advised to reduce consumption by half during weeks 7-9 and three-quarters during weeks 10-12.
干预措施: Nicotine Gum (Drug)
Snus
Oral tobacco (Camel Snus) was provided to the participants for an 12 weeks. Participants were encouraged to completely substitute snus for cigarettes and asked to use at least 6-8 pieces a day or optimally every 1-2 h and more if necessary. They were advised to reduce consumption by half during weeks 7-9 and three-quarters during weeks 10-12.
干预措施: Oral tobacco (Other)
结局指标
主要结局
Product Effect on Complete Substitution for Smoking
时间窗: 6 week post smoking substitution
Number of subjects using only the assigned study product at week 6
Number of Cigarettes Smoked
时间窗: 6 weeks post cigarette substitution
Cigarettes per day at mid intervention
Number of Products Used
时间窗: 6 weeks post smoking substitution
Pieces of product per week at mid intervention
次要结局
- Products Effect on Withdrawal Symptoms.(Week 1-12 post switching)
- Product Effect on Biomarkers of Exposure and Toxicity(Baseline and Week 4 post smoking substitution)