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临床试验/NCT04358315
NCT04358315终止不适用

Consumer Assessment of Tobacco Flavor and Odor

Roswell Park Cancer Institute1 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2023年4月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
29
试验地点
1
主要终点
Flavor combination thresholds

研究概览

简要总结

This trial studies consumer assessments of tobacco flavor and odor. This study will compare the ability of expert and consumer panels to identify and characterize flavors, determine threshold detection levels for individual and mixed flavors, and identify the dominant flavor of mixtures.

详细描述

PRIMARY OBJECTIVE:

I. Develop consumer (untrained) sensory panels to identify and assess characterizing flavors in electronic (e)-liquids.

OUTLINE:

Non-user panelists smell and user panelists puff flavored e-liquids and answer questions about the products.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
21 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • CONSUMER USER: Current daily vapers of products containing nicotine
  • CONSUMER USER: No concurrent use of other tobacco products
  • CONSUMER USER: General good health
  • CONSUMER USER: No allergies
  • CONSUMER USER: No self-reported taste or smell deficits
  • CONSUMER USER: Not pregnant or lactating
  • CONSUMER USER: No medications known to interfere with taste/smell
  • CONSUMER USER: Passing scores on the Brief Smell Identification Test (B-SIT), phenylthiocarbamine (PTC) and 6-n-propylthiouracil (PROP) smell and taste tests
  • CONSUMER USER: No positive diagnosis of COVID-19 within 30 days
  • CONSUMER NONUSER: No use of tobacco or nicotine products in the last year
  • CONSUMER NONUSER: General good health
  • CONSUMER NONUSER: No allergies
  • CONSUMER NONUSER: No self-reported taste or smell deficits
  • CONSUMER NONUSER: Not pregnant or lactating
  • CONSUMER NONUSER: No medications known to interfere with taste/smell
  • CONSUMER NONUSER: Passing scores on the Brief Smell Identification Test (B-SIT), phenylthiocarbamine (PTC) and 6-n-propylthiouracil (PROP) smell and taste tests
  • CONSUMER NONUSER: No positive diagnosis of COVID-19 within 30 days

排除标准

  • CONSUMER USER: Outside age range
  • CONSUMER USER: Not current daily vapers
  • CONSUMER USER: Concurrent use of other tobacco products
  • CONSUMER USER: Fair or poor general health
  • CONSUMER USER: Allergies
  • CONSUMER USER: Self-reported taste or smell deficits
  • CONSUMER USER: Pregnant or lactating
  • CONSUMER USER: Medications known to interfere with taste/smell
  • CONSUMER USER: Failing scores on the Brief Smell Identification Test (B-SIT), phenylthiocarbamine (PTC) and 6-n-propylthiouracil (PROP) smell and taste tests
  • CONSUMER USER: Positive diagnosis of COVID-19 within 30 days
  • CONSUMER NONUSER: Outside age range
  • CONSUMER NONUSER: Use of tobacco or nicotine products in the last year
  • CONSUMER NONUSER: Fair or poor general health
  • CONSUMER NONUSER: Allergies
  • CONSUMER NONUSER: Self-reported taste or smell deficits
  • CONSUMER NONUSER: Pregnant or lactating
  • CONSUMER NONUSER: Medications known to interfere with taste/smell
  • CONSUMER NONUSER: Failing scores on the Brief Smell Identification Test (B-SIT), phenylthiocarbamine (PTC) and 6-n-propylthiouracil (PROP) smell and taste tests
  • CONSUMER NONUSER: Positive diagnosis of COVID-19 within 30 days

研究组 & 干预措施

Observational (smell or puff e-liquids)

All panel participants smell and user panelists puff flavored e-liquids and answer questions about the products.

干预措施: Behavioral Intervention (Behavioral)

Observational (smell or puff e-liquids)

All panel participants smell and user panelists puff flavored e-liquids and answer questions about the products.

干预措施: Questionnaire Administration (Other)

结局指标

主要结局

Flavor combination thresholds

时间窗: Up to 12 months

Subjects will rate a combination of two e-liquids combined

Flavor identification and evaluation

时间窗: Up to 12 months

Subjects will be asked to identify various concentrations of flavored e-liquids

Specific flavor detection thresholds

时间窗: Up to 12 months

Subjects will rate intensity of odors of e liquids

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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