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临床试验/NCT03830892
NCT03830892终止不适用

Effects of E-Cigarette Power and Nicotine Content in Dual Users and Vapers

Virginia Commonwealth University1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2019年1月18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
48
试验地点
1
主要终点
Breakpoint of Drug Purchase Tasks (DPT)

研究概览

简要总结

This study aims to understand the effects of device power and nicotine concentration on the likelihood that someone would use or abuse e-cigarettes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Single (Participant)

盲法说明

Participants will be blinded to their condition (power level and nicotine concentration) used in each session, except during their 'own brand' session.

入排标准

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

入选标准

  • •healthy (determined by self-report)
  • •between the ages of 21-55
  • •willing to provide informed consent
  • •able to attend the lab and abstain from tobacco/nicotine as required and must agree to use designated products according to study protocol

排除标准

  • •Women if they are breast-feeding or test positive for pregnancy (by urinalysis) at screening.
  • •Some study details about the eligibility criteria are purposely omitted at this time to preserve scientific integrity. Full details will be posted at the conclusion of the study.

研究组 & 干预措施

E-cigarette User (Exclusive)

Active Comparator

Other: E-cigarette Lab Session 15 watts, 10 mg nicotine Other: E-cigarette Lab Session 15 watts, 30 mg nicotine Other: E-cigarette Lab Session 30 watts, 10 mg nicotine Other: E-cigarette Lab Session 30 watts, 30 mg nicotine Other: Own Brand Session - E-cigarette

干预措施: E-cigarette Lab Session 15 watts, 30 mg nicotine (Other)

E-cigarette User (Exclusive)

Active Comparator

Other: E-cigarette Lab Session 15 watts, 10 mg nicotine Other: E-cigarette Lab Session 15 watts, 30 mg nicotine Other: E-cigarette Lab Session 30 watts, 10 mg nicotine Other: E-cigarette Lab Session 30 watts, 30 mg nicotine Other: Own Brand Session - E-cigarette

干预措施: E-cigarette Lab Session 15 watts, 10 mg nicotine (Other)

E-cigarette User (Exclusive)

Active Comparator

Other: E-cigarette Lab Session 15 watts, 10 mg nicotine Other: E-cigarette Lab Session 15 watts, 30 mg nicotine Other: E-cigarette Lab Session 30 watts, 10 mg nicotine Other: E-cigarette Lab Session 30 watts, 30 mg nicotine Other: Own Brand Session - E-cigarette

干预措施: E-cigarette Lab Session 30 watts, 10 mg nicotine (Other)

E-cigarette User (Exclusive)

Active Comparator

Other: E-cigarette Lab Session 15 watts, 10 mg nicotine Other: E-cigarette Lab Session 15 watts, 30 mg nicotine Other: E-cigarette Lab Session 30 watts, 10 mg nicotine Other: E-cigarette Lab Session 30 watts, 30 mg nicotine Other: Own Brand Session - E-cigarette

干预措施: E-cigarette Lab Session 30 watts, 30 mg nicotine (Other)

E-cigarette User (Exclusive)

Active Comparator

Other: E-cigarette Lab Session 15 watts, 10 mg nicotine Other: E-cigarette Lab Session 15 watts, 30 mg nicotine Other: E-cigarette Lab Session 30 watts, 10 mg nicotine Other: E-cigarette Lab Session 30 watts, 30 mg nicotine Other: Own Brand Session - E-cigarette

干预措施: Own Brand Session - E-cigarette (Other)

Dual User

Active Comparator

Other: E-cigarette Lab Session 15 watts, 10 mg nicotine Other: E-cigarette Lab Session 15 watts, 30 mg nicotine Other: E-cigarette Lab Session 30 watts, 10 mg nicotine Other: E-cigarette Lab Session 30 watts, 30 mg nicotine Other: Own Brand Session - E-cigarette/Cigarette

干预措施: E-cigarette Lab Session 15 watts, 10 mg nicotine (Other)

Dual User

Active Comparator

Other: E-cigarette Lab Session 15 watts, 10 mg nicotine Other: E-cigarette Lab Session 15 watts, 30 mg nicotine Other: E-cigarette Lab Session 30 watts, 10 mg nicotine Other: E-cigarette Lab Session 30 watts, 30 mg nicotine Other: Own Brand Session - E-cigarette/Cigarette

干预措施: E-cigarette Lab Session 15 watts, 30 mg nicotine (Other)

Dual User

Active Comparator

Other: E-cigarette Lab Session 15 watts, 10 mg nicotine Other: E-cigarette Lab Session 15 watts, 30 mg nicotine Other: E-cigarette Lab Session 30 watts, 10 mg nicotine Other: E-cigarette Lab Session 30 watts, 30 mg nicotine Other: Own Brand Session - E-cigarette/Cigarette

干预措施: E-cigarette Lab Session 30 watts, 10 mg nicotine (Other)

Dual User

Active Comparator

Other: E-cigarette Lab Session 15 watts, 10 mg nicotine Other: E-cigarette Lab Session 15 watts, 30 mg nicotine Other: E-cigarette Lab Session 30 watts, 10 mg nicotine Other: E-cigarette Lab Session 30 watts, 30 mg nicotine Other: Own Brand Session - E-cigarette/Cigarette

干预措施: E-cigarette Lab Session 30 watts, 30 mg nicotine (Other)

Dual User

Active Comparator

Other: E-cigarette Lab Session 15 watts, 10 mg nicotine Other: E-cigarette Lab Session 15 watts, 30 mg nicotine Other: E-cigarette Lab Session 30 watts, 10 mg nicotine Other: E-cigarette Lab Session 30 watts, 30 mg nicotine Other: Own Brand Session - E-cigarette/Cigarette

干预措施: Own Brand Session - E-cigarette (Other)

Dual User

Active Comparator

Other: E-cigarette Lab Session 15 watts, 10 mg nicotine Other: E-cigarette Lab Session 15 watts, 30 mg nicotine Other: E-cigarette Lab Session 30 watts, 10 mg nicotine Other: E-cigarette Lab Session 30 watts, 30 mg nicotine Other: Own Brand Session - E-cigarette/Cigarette

干预措施: Own Brand Session - E-cigarette/Cigarette (Other)

结局指标

主要结局

Breakpoint of Drug Purchase Tasks (DPT)

时间窗: Up to 180 minutes

The DPTs will yield measures of willingness to pay and measures of price sensitivity for session-specific tobacco products. Choices made during this task are not reinforced during the session. Each DPT will be completed once per study session (either 90 minutes or approximately 180 minutes into the session, timing varies based on task order presentation and potentially choices made in tasks presented prior to this task).

Effort for Product Puffs With the Progressive Ratio Task (PRT)

时间窗: Up to 180 minutes.

The PRT will yield a measure of willingness to work for session-specific tobacco products (via number of times a space bar is pressed to earn puffs) by measuring the number of puffs self-administrated. Completed once per study session (either 90 minutes or approximately 180 minutes into the session, timing varies based on task order presentation and potentially choices made in tasks presented prior to this task).

Breakpoint of Multiple Choice Procedure (MCP)

时间窗: Up to 180 minutes.

The MCP will yield of measure of willingness to pay for session-specific tobacco products. One choice made during this task is reinforced (i.e., money or tobacco product is distributed). Completed once per study session (either 90 minutes or approximately 180 minutes into the session, timing varies based on task order presentation and potentially choices made in tasks presented prior to this task).

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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