Effects of E-Cigarette Nicotine Content in Smokers (Nicotine Flux Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Effort for Product Puffs With Cross Product Progressive Ratio Task (CP-PRT)
研究概览
简要总结
This study aims to better understand how e-cigarettes (ECIG) nicotine flux impacts several behavioral economic measures of abuse liability.
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 (Participant)
盲法说明
Participants will be blinded to their condition (nicotine level) used in each session, except during their 'own brand' session.
入排标准
- 年龄范围
- 18 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 18-55
- •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
Experimental
干预措施: Tobacco product administration and assessment, own brand cigarettes (Other)
Experimental
干预措施: Tobacco product administration and assessment, ECIG 30 Watts, 0 mg/ml nicotine (Other)
Experimental
干预措施: Tobacco product administration and assessment, ECIG 30 Watts, 8 mg/ml nicotine (Other)
Experimental
干预措施: Tobacco product administration and assessment, ECIG 30 Watts, 15 mg/ml nicotine (Other)
Experimental
干预措施: Tobacco product administration and assessment, ECIG 30 Watts, 30 mg/ml nicotine (Other)
结局指标
主要结局
Effort for Product Puffs With Cross Product Progressive Ratio Task (CP-PRT)
时间窗: The CP-PRT is completed once per study session (except it is not completed in the 5th, own brand session), at 185 minutes into the session.
This is now a single-arm parallel study design. The main outcome of interest in the CP-PRT is the relative reinforcing value - defined as how hard a participant is willing to work for the session product compared to their own brand cigarette. The breakpoint, or highest trial number that a participant completed for a puff of the session-specific product will be used as the measure of relative reinforcing value.
Breakpoint of Drug Purchase Task (DPT)
时间窗: Each DPT will be completed once per study session, about 75 minutes into the session. The results will reported in US dollars ($).
The DPTs will yield measures of willingness to pay (demand) for session-specific tobacco products. Choices made during this task are not reinforced during the session. Using the DPT, participants estimate the number of session-specific product puffs they would take across increasing prices per puff. DPT demand will be characterized by the Breakpoint (BP); i.e., the highest price per puff at which participants indicate they would stop using the session-specific product rather than incur the cost.
Effort for Product Puffs With Progressive Ratio Task (PRT)
时间窗: The PRT is completed once per study session, at 85 minutes into the session.
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) through the outcome measure: mean number of puffs self-administrated. The outcome measure of interest is the total number of puffs self-administered.
次要结局
未报告次要终点