Nicotine ExposurePhase 1NCT02500615
The Effect of Electronic Cigarette (ECIG) Liquid Vehicles on ECIG Acute Effects
A Phase 1 study of Nicotine Exposure and Nicotine Withdrawal Suppression, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
This study examines the acute effects in ECIG users of the two primary vehicles in ECIG liquids, propylene glycol and vegetable glycerin. Thirty experienced ECIG users will use an ECIG in five conditions that will differ only by the propylene glycol:vegetable glycerin ratio: 100:0, 70:30, 50:50, 30:70, and 0:100… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Nicotine Exposure, Nicotine Withdrawal Suppression
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to 16 May 2017
- Phase
- Phase 1
- 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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants must use ≥1 ml of ECIG solution daily
- Must use ECIG solution with a nicotine concentration ≥12 mg/ml
- Must have used an ECIG for ≥3 months
- Must be willing to abstain from nicotine and tobacco products for ≥12 hours prior to each session.
Who cannot join
- History of chronic disease or psychiatric condition
- Regular use of a prescription medication
- Marijuana use >10 and alcohol use >25 days in the past 30
- Any other illicit drug use (e.g., cocaine, opioids) in the past 30 days.
- Positive test for pregnancy (by urinalysis)
- Daily use of >5 conventional tobacco cigarettes
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Behavioral Pharmacology Laboratory
Richmond, Virginia, 23298
About this study
This study examines the acute effects in ECIG users of the two primary vehicles in ECIG liquids, propylene glycol and vegetable glycerin. Thirty experienced ECIG users will use an ECIG in five conditions that will differ only by the propylene glycol:vegetable glycerin ratio: 100:0, 70:30, 50:50, 30:70, and 0:100 (device voltage, heater resistance, liquid nicotine concentration, puff number, and interpuff interval all will be held constant). Plasma nicotine concentration, subjective effects, and puffing behaviors will be recorded in each condition.
Read the detailed description
Electronic cigarettes (ECIGs) are among the most important issues in public health today due to their dramatic increase in popularity. However, very little is known about ECIGs, including what factors may make them more likely to be used and abused. Examining factors that influence nicotine yield, delivery, and subjective effects from ECIGs is essential to understanding their abuse liability. Limited pre-clinical research has revealed that nicotine yield may be influenced by the ratio of the two liquid vehicles, propylene glycol (PG) and vegetable glycerin (VG), most commonly found in ECIG solutions. Specifically, higher proportions of PG result in greater nicotine yields. However, the influence of PG:VG ratio on nicotine delivery and subjective effects associated with ECIG use has not been examined previously. The primary hypotheses are that higher proportions of PG will result in greater nicotine delivery and subjective effect profiles suggestive of higher abuse liability in ECIG users. Results from this project will result in further understanding of the factors that influence the abuse liability of ECIGs and could inform regulation of these products.
- Conditions
- Nicotine Exposure, Nicotine Withdrawal Suppression
- Being tested
- ECIG liquid vehicles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECIG liquid vehiclesOther
The ratio of propylene glycol and vegetable glycerin will be changed while all other factors of the electronic cigarette provided to participants will be held constant.
| Study group | Role | What they receive |
|---|---|---|
| 0 PG: 100 VG | Experimental | Not described Receives: Other: ECIG liquid vehicles |
| 30 PG: 70 VG | Experimental | Not described Receives: Other: ECIG liquid vehicles |
| 50 PG: 50 VG | Experimental | Not described Receives: Other: ECIG liquid vehicles |
| 70 PG: 30 VG | Experimental | Not described Receives: Other: ECIG liquid vehicles |
| 100 PG: 0 VG | Experimental | Not described Receives: Other: ECIG liquid vehicles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma nicotine concentration (ng/ml)
taken via intravenous catheter
Measured: Collected at each of the 5 visits. Participants can complete up to 2 sessions/week. Thus the average time period to complete all 5 sessions is approximately 3 weeks. Each individual session is approximately 3 hours long.
Withdrawal suppression items on a visual analog scale
provided using computerized questionnaire
Measured: Collected at each of the 5 visits. Participants can complete up to 2 sessions/week. Thus the average time period to complete all 5 sessions is approximately 3 weeks. Each individual session is approximately 3 hours long.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2015 (estimated)
- Study startJul 2016
- Primary completion16 May 2017
- Study completion16 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nicotine ExposureStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Tory R Spindle, B.S., Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02500615
- Sponsor's protocol ID
- HM20004850
- Other IDs
- 1F31DA040319-01
- Status last verified
- May 2018
- First submitted
- 6 Jul 2015
- Last updated
- 7 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Electronic Cigarette (ECIG) Liquid Vehicles on ECIG Acute Effects
- ClinicalTrials.gov ID
- NCT02500615
- Acronym / sponsor ID
- HM20004850
- Conditions
- Nicotine Exposure, Nicotine Withdrawal Suppression
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jul 2016
- Primary completion
- 16 May 2017 (actual)
- Study completion
- 16 May 2017 (actual)
- First posted
- 16 Jul 2015 (estimated)
- 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.
This study examines the acute effects in ECIG users of the two primary vehicles in ECIG liquids, propylene glycol and vegetable glycerin. Thirty experienced ECIG users will use an ECIG in five conditions that will differ only by the propylene glycol:vegetable glycerin ratio: 100:0, 70:30, 50:50, 30:70, and 0:100 (device voltage, heater resistance, liquid nicotine concentration, puff number, and interpuff interval all will be held constant). Plasma nicotine concentration, subjective effects, and puffing behaviors will be recorded in each condition.
Detailed description
Electronic cigarettes (ECIGs) are among the most important issues in public health today due to their dramatic increase in popularity. However, very little is known about ECIGs, including what factors may make them more likely to be used and abused. Examining factors that influence nicotine yield, delivery, and subjective effects from ECIGs is essential to understanding their abuse liability. Limited pre-clinical research has revealed that nicotine yield may be influenced by the ratio of the two liquid vehicles, propylene glycol (PG) and vegetable glycerin (VG), most commonly found in ECIG solutions. Specifically, higher proportions of PG result in greater nicotine yields. However, the influence of PG:VG ratio on nicotine delivery and subjective effects associated with ECIG use has not been examined previously. The primary hypotheses are that higher proportions of PG will result in greater nicotine delivery and subjective effect profiles suggestive of higher abuse liability in ECIG users. Results from this project will result in further understanding of the factors that influence the abuse liability of ECIGs and could inform regulation of these products.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 0 PG: 100 VG | Experimental | Other: ECIG liquid vehicles |
| 30 PG: 70 VG | Experimental | Other: ECIG liquid vehicles |
| 50 PG: 50 VG | Experimental | Other: ECIG liquid vehicles |
| 70 PG: 30 VG | Experimental | Other: ECIG liquid vehicles |
| 100 PG: 0 VG | Experimental | Other: ECIG liquid vehicles |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Participants must use ≥1 ml of ECIG solution daily
- Must use ECIG solution with a nicotine concentration ≥12 mg/ml
- Must have used an ECIG for ≥3 months
- Must be willing to abstain from nicotine and tobacco products for ≥12 hours prior to each session.
Key exclusion criteria (6 listed)
- History of chronic disease or psychiatric condition
- Regular use of a prescription medication
- Marijuana use >10 and alcohol use >25 days in the past 30
- Any other illicit drug use (e.g., cocaine, opioids) in the past 30 days.
- Positive test for pregnancy (by urinalysis)
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 |
|---|---|---|
| ECIG liquid vehiclesThe ratio of propylene glycol and vegetable glycerin will be changed while all other factors of the electronic cigarette provided to participants will be held constant. | Other | 0 PG: 100 VG, 100 PG: 0 VG, 30 PG: 70 VG, 50 PG: 50 VG, 70 PG: 30 VG |
Primary outcome
Plasma nicotine concentration (ng/ml)
Time frame: Collected at each of the 5 visits. Participants can complete up to 2 sessions/week. Thus the average time period to complete all 5 sessions is approximately 3 weeks. Each individual session is approximately 3 hours long.
taken via intravenous catheter
Withdrawal suppression items on a visual analog scale
Time frame: Collected at each of the 5 visits. Participants can complete up to 2 sessions/week. Thus the average time period to complete all 5 sessions is approximately 3 weeks. Each individual session is approximately 3 hours long.
provided using computerized questionnaire
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 7 May 2018.
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Brain/Craving Response to Smoking Cues After Oral Nicotine Pouch Use
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Melanin and Dermal Uptake of Thirdhand Cigarette Smoke
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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.
Tory R Spindle, B.S. principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study of Nicotine Exposure and Nicotine Withdrawal Suppression, run by Virginia Commonwealth 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 6 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 7 May 2018. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Plasma nicotine concentration (ng/ml) (time frame: Collected at each of the 5 visits. Participants can complete up to 2 sessions/week. Thus the average time period to complete all 5 sessions is approximately 3 weeks. Each individual session is approximately 3 hours long.). 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?
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 7 May 2018.