Combining a Smoke Ending Aid With Behavioral Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Abstinence Rate
研究概览
简要总结
The purpose of this study is to combine a smoke ending aid with behavioral treatment.
详细描述
The prime objective of this Innovative Stage I A/B Behavioral Therapy Development Research project is to conduct a pilot study under randomized, double-blind, placebo controlled conditions, to provide preliminary estimation of the efficacy of a 6 week Accu Drop nicotine fading protocol used in conjunction with cigarette tapering to bring about termination of cigarette usage in moderate to heavy smokers (*15 cpd) who are interested in smoking cessation. Both the experimental and control groups in this study will receive six weeks of the manually driven behavioral treatment by experienced and trained therapists. The experimental group (N=30) will also be prescribed active Accu Drops (AD&C) while the control condition (N=30) will be prescribed placebo Accu Drops (PD&C) very similar in appearance, viscosity, and taste to active Accu Drops. Completion of the study protocol and smoking cessation rates at 1 week, 1 month, and 6 months post-treatment will be the prime measures of efficacy. The findings of this study will provide sufficient preliminary indication for the efficacy of the experimental treatment and its extended investigation in a Phase II study or for its nonefficacy.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 21 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •21 years of age or older, and no greater than 65 years of age
- •Medically stable
- •Smoke at least 15 filtered cigarettes daily
- •Motivated to quit smoking
排除标准
- •Medically unstable
- •Currently psychiatrically unstable (schizophrenia, unstable psychosis, untreated major depression, active substance abuse within the past 6 months)
研究组 & 干预措施
Accu Drops (AD&C)
The experimental group (N=30) will be prescribed active Accu Drops (AD&C) plus behavioral therapy.
干预措施: Behavioral Therapy (Behavioral)
Placebo
The control condition (N=30) will be prescribed placebo Accu Drops (PD&C) plus behavioral therapy.
干预措施: Behavioral Therapy (Behavioral)
结局指标
主要结局
Abstinence Rate
时间窗: 1 year
The main outcome measures were rates of treatment completion and smoking abstinence. It was hypothesized that the nicotine blocking agent product would lead to higher treatment completion rates, higher abstinence rates, and fewer problems with withdrawal than the placebo group.
次要结局
未报告次要终点
研究者
Peter Gariti
Sponsor-Investigator
University of Pennsylvania
