Modeling Stress-precipitated Vaping Behavior

Vaping Clinical Trial

Official title:

Modeling Stress-precipitated Vaping Behavior Among E-Cigarette Users

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04522362
• Other study ID #: 17-0498
• Status: Completed
• Phase: N/A
• Start date: October 25, 2017
• Est. completion date: June 30, 2018

Study information

• Verified date: August 2020
• Source: Clemson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: June 30, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Vaping

Intervention

Other:
• Control task and Trier Social Stress Task
Same as Arm

Locations

Country	Name	City	State
United States	University of Vermont	Burlington	Vermont

Sponsors (2)

Lead Sponsor	Collaborator
Clemson University	University of Vermont

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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
Secondary	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