Modeling Stress-precipitated Vaping Behavior

Modeling Stress-precipitated Vaping Behavior Among E-Cigarette Users

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.

Study Overview

• Status: Completed
• Conditions: Vaping
• Intervention / Treatment: Other: Control task and Trier Social Stress Task

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Vermont
    • Burlington, Vermont, United States, 05405
      • University of Vermont

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Control task-; 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).	Other: Control task and Trier Social Stress Task; Same as Arm
Experimental: Experimental Task- Trier Social Stress Task; 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.	Other: Control task and Trier Social Stress Task; Same as Arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
latency to initiate ad-lib vaping session (in minutes)	Time to vaping during the vaping delay task. Range of time delay is 0 minutes to 50 minutes.	During the two laboratory sessions which occur within 1 week after screening/baseline.
number of puffs purchased and consumed during the self-administration period	Number of e-cigarette uses purchased during the self-administration phase of the vaping delay task. Range of puffs is 0 to 20.	During the two laboratory sessions which occur within 1 week after screening/baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Craving	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).	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	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).	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

Collaborators and Investigators

• Sponsor: Clemson University
• Collaborators: University of Vermont

Publications and helpful links

General Publications

• Pericot-Valverde I, Yoon JH, Byrne KA, Heo M, Niu J, Litwin AH, Gaalema DE. Effects of short-term nicotine deprivation on delay discounting among young, experienced, exclusive ENDS users: An initial study. Exp Clin Psychopharmacol. 2022 Nov 10. doi: 10.1037/pha0000612. Online ahead of print.
• Pericot-Valverde I, Heo M, Litwin AH, Niu J, Gaalema DE. Modeling the effect of stress on vaping behavior among young adults: A randomized cross-over pilot study. Drug Alcohol Depend. 2021 Aug 1;225:108798. doi: 10.1016/j.drugalcdep.2021.108798. Epub 2021 May 30.

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2017
• Primary Completion (Actual): June 30, 2018
• Study Completion (Actual): June 30, 2018

Study Registration Dates

• First Submitted: August 13, 2020
• First Submitted That Met QC Criteria: August 19, 2020
• First Posted (Actual): August 21, 2020

Study Record Updates

• Last Update Posted (Actual): August 21, 2020
• Last Update Submitted That Met QC Criteria: August 19, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 17-0498

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No