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临床试验/NCT06191419
NCT06191419已完成不适用

Human Perception of Odors and Odor Blockers

Tim McClintock1 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2024年4月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
27
试验地点
1
主要终点
Desire to Smoke

研究概览

简要总结

The goal of this clinical trial is to determine whether blockers of perception of key odorants in cigarette smoke have any utility in smoking cessation. The main question it aims to answer is:

• Can odor blockers be used to suppress perception of the intensity of cigarette smoke in ways that reduce the ability of the odor of cigarette smoke to increase the urge to smoke.

Participants will be asked to smell up to 20 odor samples per session and report on odor pleasantness and desire to smoke.

详细描述

The experimental treatments include controls (clean air, irrelevant odor), blocking odors, cigarette smoke odor, and cigarette smoke odor mixed with blocking odors or irrelevant odor. To obtain cigarette smoke odor a 1 inch length of a 1R6F research cigarette is burned to completion in a sealed 5 gallon chamber fitted with septa. Using a syringe fit with a needle and filter, 60 mL aliquots of smoke odor are obtained. These smoke odor aliquots, along with blocking odors, are injected into odor sample bags fit with a septum and a valve that can be attached to the CPAP nose mask worn by each participating smoker. Participants open the valve, inhale once through the nose, close the valve, and then remove the bag from the mask before reporting odor pleasantness and the desire to smoke. A 4 min wait period is enforced between each odor presentation to prevent odor adaptation and to allow acute motivational effects to subside. During these intervals, a nature documentary was available for viewing. Two measures of the desire to smoke are made. An objective method uses a validated relative reinforcing measure, requiring participants to record how many cigarettes they would purchase at each step along a logarithmically increasing price scale that ranges from $0 to $1,120 per cigarette. The breakpoint on this scale at which a participant is no longer willing to pay is the measure of the urge to smoke. As a subjective measure, participants report their urge to smoke as a value between 0 and 100. Participants also provide a forced choice measure of odor pleasantness, indicating either pleasant or unpleasant for each odor.

In a testing session a participant sniffs a mixture of blocking odors mixed with cigarette smoke, along with control odor samples. Presentation order is randomized. Each participant is assigned their own CPAP nose mask, and masks are disinfected after use. Participants also provide demographic (age, sex, ethnic and racial background) and smoking history information (cigarettes per day, preferred brand, age at onset, and time since last cigarette).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

盲法说明

Odor bags are prepared by one staff member and labeled with a code so that other investigators administering tests cannot identify which treatment is being given and inadvertently influence outcomes. The code is not visible to participants. This prevents participants from anticipating the effect of the treatment.

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • 未提供

排除标准

  • •Non Smoker
  • •Self reported inability to smell or taste

研究组 & 干预措施

Participants that Smoke

Experimental

Each smoker is asked to smell up to 20 samples per session. Samples include controls (clean air, irrelevant odor), blocking odors, cigarette smoke, and cigarette smoke mixed with blocking odors or irrelevant odors.

干预措施: Odorants (Other)

结局指标

主要结局

Desire to Smoke

时间窗: 3 hours (total for all outcome measures)

A rating of participant's desire to smoke on a scale of 0 - 100, where a higher score indicates increased desire.

Cigarette Purchase Task

时间窗: 3 hours (total for all outcome measures)

The Cigarette Purchase Task (Strickland et al., 2016) requires selecting how much the smoker is willing to spend for a single cigarette (their preferred brand) from a list of 19 amounts ranging from $0.00 (free) to $1,120. The measure from the selections is the breakpoint where the participants are no longer willing to purchase. These data are skewed and are log transformed (after adding 0.01) for statistical analysis.

次要结局

  • Odor Pleasantness Score(3 hours (total for all outcome measures))

研究者

发起方
Tim McClintock
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Tim McClintock

Professor

University of Kentucky

研究点 (1)

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