Modeling Stress-precipitated Vaping Behavior

NCT04522362 | Completed

• 1 other identifier: 17-0498
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Vaping

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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

Study Arms (2)

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).

Other: Control task and Trier Social Stress Task

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.

Other: Control task and Trier Social Stress Task

Interventions

Control task and Trier Social Stress Task OTHER

Same as Arm

Control task-; Experimental Task- Trier Social Stress Task

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Clemson University: lead
• University of Vermont: collaborator

Study Sites (1)

University of Vermont

Burlington, Vermont, 05405, United States

Location

Related Publications (2)

• 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. 2023 Jun;31(3):724-732. doi: 10.1037/pha0000612. Epub 2022 Nov 10.

  PMID: 36355684 DERIVED

• 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.

  PMID: 34091155 DERIVED

MeSH Terms

Conditions

Vaping

Condition Hierarchy (Ancestors)

Smoking; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: August 13, 2020
• First Posted: August 21, 2020
• Study Start: October 25, 2017
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2018
• Last Updated: August 21, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)