VapingNCT04522362
Modeling Stress-precipitated Vaping Behavior
A study of Vaping, run by Clemson University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vaping
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 2017to 30 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Current smokers
- Psychiatric or medical condition based
- Using a prescription medication other than birth control
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Vaping
- Being tested
- Control task and Trier Social Stress Task
- Medical subject headings
- Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control task and Trier Social Stress TaskOther
Same as Arm
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Other: Control task and Trier Social Stress Task |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: During the two laboratory sessions which occur within 1 week after screening/baseline
Secondary outcomes (2)
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).
Measured: 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).
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2020
- Study start25 Oct 2017
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for VapingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Parallel Assignment
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clemson University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Vermont
- Responsible party
- Principal investigator, Irene Pericot-valverde, Clemson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04522362
- Sponsor's protocol ID
- 17-0498
- Status last verified
- Aug 2020
- First submitted
- 13 Aug 2020
- Last updated
- 21 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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. 2023 Jun;31(3):724-732. doi: 10.1037/pha0000612. Epub 2022 Nov 10.
PubMed 36355684Pericot-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.
PubMed 34091155
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modeling Stress-precipitated Vaping Behavior Among E-Cigarette Users
- ClinicalTrials.gov ID
- NCT04522362
- Acronym / sponsor ID
- 17-0498
- Conditions
- Vaping
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Clemson UniversityUniversity, hospital or other
- Collaborators
- University of Vermont
- Study start
- 25 Oct 2017 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 21 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Control task- | Sham comparator | Other: Control task and Trier Social Stress TaskThe 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). |
| Experimental Task- Trier Social Stress Task | Experimental | Other: Control task and Trier Social Stress TaskThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Current smokers
- Psychiatric or medical condition based
- Using a prescription medication other than birth control
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control task and Trier Social Stress TaskSame as Arm | Other | Control task-, Experimental Task- Trier Social Stress Task |
Primary outcome
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.
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.
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2020.
- Derived from this study: PubMed 36355684Pericot-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.
- Derived from this study: PubMed 34091155Pericot-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.
- Individual participant dataSharing planned: No
Related trials for Vaping
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Pilot Study of Communication for Dual Users of Cigarettes and E-cigarettes
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Circuit Breathing Exercise on Smoking Cessation Among Youth E-Cigarette Users
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Vaping, run by Clemson University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
latency to initiate ad-lib vaping session (in minutes) (time frame: During the two laboratory sessions which occur within 1 week after screening/baseline.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04522362, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2020.