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Completed

NCT Number: NCT04522362

Modeling Stress-precipitated Vaping Behavior

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.

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Key information

Conditions

Vaping Behavior Smoking

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Vermont

Burlington, Vermont, 05405, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Control task and Trier Social Stress Task

Other

Same as Arm

Primary outcomes

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

    Time frame: 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.

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

    Time frame: 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.

Secondary outcomes

  1. Craving

    Time frame: 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

    Craving was measured using a visual analogue scale (VAS) asking "How much do you crave an e-cigarette right now?" with possible responses ranging from 0 (not at all) to 100 (extremely).

  2. Stress

    Time frame: 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 was measured using a visual analogue scale (VAS) asking: "How stressed or anxious do you feel right now?" with possible responses ranging from 0 (not at all) to 100 (extremely).

Sponsors and collaborators

Lead sponsor

Clemson University

Other

Collaborators

  • University of Vermont

Registry information

Official study title

Modeling Stress-precipitated Vaping Behavior Among E-Cigarette Users

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 21, 2020
Registry last updated
Aug 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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