Modeling Stress-precipitated Vaping Behavior

NCT ID: NCT04522362

Last Updated: 2020-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-25

Study Completion Date

2018-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Vaping

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Parallel Assignment
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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).

Group Type SHAM_COMPARATOR

Control task and Trier Social Stress Task

Intervention Type OTHER

Same as Arm

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.

Group Type EXPERIMENTAL

Control task and Trier Social Stress Task

Intervention Type OTHER

Same as Arm

Interventions

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Control task and Trier Social Stress Task

Same as Arm

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Vermont

OTHER

Sponsor Role collaborator

Clemson University

OTHER

Sponsor Role lead

Responsible Party

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Irene Pericot-valverde

Research Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Vermont

Burlington, Vermont, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 36355684 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34091155 (View on PubMed)

Other Identifiers

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17-0498

Identifier Type: -

Identifier Source: org_study_id

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