跳至主要内容
临床试验/NCT04522362
NCT04522362已完成不适用

Modeling Stress-precipitated Vaping Behavior Among E-Cigarette Users

Clemson University1 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2017年10月25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
入组人数
51
试验地点
1
主要终点
latency to initiate ad-lib vaping session (in minutes)

研究概览

简要总结

The primary aims of this pilot study were to (1) initially validate the applicability of a human laboratory model of relapse initially developed for smokers to e-cigarette users; (2) to use this human laboratory model of lapse behavior to examine the effects of acute psychological stress on vaping-lapse behavior among adults who are experienced, e-cigarette users.

研究设计

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

入排标准

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

入选标准

  • •at least 18 years old
  • •e-cigarette users
  • •using ≥1 mL of e-cigarette liquid per day with a nicotine concentration of ≥3mg/ml
  • •had used an e-cigarette for at least three months

排除标准

  • •Current smokers
  • •Psychiatric or medical condition based
  • •Using a prescription medication other than birth control

研究组 & 干预措施

Control task-

Sham Comparator

The Control Task was implemented to ensure the specificity of the psychological stress effects had on study outcomes. Therefore, the Control Task had a similar procedure and the same duration of the TSST, lacking except for only the psychologically stressful component. The control task consisted of (a) Participants had a 5-min a preparation section and anticipation phase (5 min ), (b) a reading task where they had to. Then, all participants had to be read a simple text in a low voice (5 min), and (c) an arithmetic section where they were asked to perform an easy mathematical calculation (5 mins).

干预措施: Control task and Trier Social Stress Task (Other)

Experimental Task- Trier Social Stress Task

Experimental

The Trier Social Stress Task (TSST) is a standardized, 15-minute laboratory task designed to induce psychological stress in laboratory settings (Kirschbaum, Pirke, & Hellhammer, 1993). The TSST consists of three continuously successive phases: (a) an anticipation period (5 min); (b) a free speech task (5 min); and (c) a mental arithmetic task (5 min). As is standard in the TSST procedure, participants were told by a research staff member that they would provide a brief speech about "their dream job" in front of a critical audience. At the end of the speech, a member of the audience instructed the participant to conduct serial subtractions as accurately and quickly as possible.

干预措施: Control task and Trier Social Stress Task (Other)

结局指标

主要结局

latency to initiate ad-lib vaping session (in minutes)

时间窗: During the two laboratory sessions which occur within 1 week after screening/baseline.

Time to vaping during the vaping delay task. Range of time delay is 0 minutes to 50 minutes.

number of puffs purchased and consumed during the self-administration period

时间窗: During the two laboratory sessions which occur within 1 week after screening/baseline

Number of e-cigarette uses purchased during the self-administration phase of the vaping delay task. Range of puffs is 0 to 20.

次要结局

  • Craving(The VAS will be collected at each laboratory session (within 1 week after screening/baseline) 5 times: baseline (pre task), post task (+15 minutes), decision to smoke (+20 minutes), +30 minutes smoking ab-lib, and +60 minutes during smoking ab-lib)
  • Stress(The VAS will be collected at each laboratory session (within 1 week after screening/baseline) 5 times: baseline (pre task), post task (+15 minutes), decision to smoke (+20 minutes), +30 minutes smoking ab-lib, and +60 minutes during smoking ab-lib)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Irene Pericot-valverde

Research Assistant Professor

Clemson University

研究点 (1)

Loading locations...

相似试验