Nicotine DependenceNCT03496116
The Influence of Electronic (ECIG) Heater Resistance on ECIG Acute Effects
A study testing ECIG Session in people with Nicotine Dependence, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
The purpose of this study is to measure the individual and combined influence of electronic cigarette (ECIG) heating element resistance and liquid nicotine concentration on ECIG acute effects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Nicotine Dependence
- What is being tested?
- ECIG Session
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 21 May 2018to 17 Dec 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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Willing to provide informed consent, attend the lab and abstain from nicotine/tobacco as required, and use designated products according to study protocol
- Experienced ECIG users (use ≥1 ml of ECIG solution daily, use ECIG solution with a nicotine concentration ≥3 mg/ml, and have used their ECIG for ≥3 months)
- Urine cotinine test result ≥ 3
Who cannot join
- History of organ-related diseases or current psychiatric condition
- Regular use of prescription medication other than vitamins or birth control
- Past month use of cocaine, opioids, benzodiazepines, or methamphetamine
- Using marijuana greater than 10 days in the past 30 and/or alcohol greater than 25 days in the past 30 days
- Pregnant or breastfeeding women
- Weight less than 110 pounds
- Daily use of >5 cigarettes or use of other tobacco products (i.e., hookah, cigars) >3 times a week
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
Official title: The Influence of Electronic Cigarette Heater Resistance on Nicotine Delivery, Heart Rate, Subjective Effects and Puff Topography
The purpose of this study is to measure the individual and combined influence of electronic cigarette (ECIG) heating element resistance and liquid nicotine concentration on ECIG acute effects. Thirty-two experienced ECIG users will complete four independent laboratory sessions that will differ by heater resistance (0.5 ohm or 1.5 ohm) and liquid nicotine concentration (3 or 8 mg/ml). Other factors such as voltage, liquid solvent ratio, and liquid flavor will be held constant. Plasma nicotine concentration, subjective effects, and puffing behavior will be recorded for each condition.
Read the detailed description
Electronic cigarettes (ECIGs) are a popular and rapidly evolving class of products. ECIG users can manipulate several device features including liquid nicotine concentration (mg/ml) and heating element resistance (ohms). An emerging class of ECIG models includes "sub-Ohm" devices that employ low resistance heaters that are often used to achieve high device power. Some clinical laboratory data suggest that high power devices deliver nicotine to the user effectively, even when paired with a low liquid nicotine concentration. However, given that ECIG heater resistance and liquid nicotine concentration have not been manipulated in clinical laboratory studies, the influence of these factors on ECIG acute effects remain unclear. The purpose of this clinical laboratory study is to measure the influence of heater resistance and liquid nicotine concentration on ECIG acute effects. Participants will attend the lab for four experimental sessions where they use an ECIG. For each session, the participants will be randomly assigned (like the flip of a coin) to receive an ECIG with one of two different levels of heating coil resistance (which will determine overall device power) and one of two different liquid nicotine concentrations. The four sessions will begin at approximately the same time each day, will be separated by at least 48 hours, and will not occur more than two times per week. The primary hypotheses are that the low resistance heater paired with the 8 mg/ml liquid nicotine concentration, will result in greater nicotine delivery and subjective effect profiles, suggestive of higher abuse potential. Results from this study will further our understanding of the factors that influence the dependence potential of ECIGs and could inform future regulation of these devices.
- Conditions
- Nicotine Dependence
- Being tested
- ECIG Session
- Medical subject headings
- Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECIG SessionOther
Participants will complete four sessions using an e-cigarette, including a 10-puff product use bout followed by a 60-minute ad lib bout over an approximately 4-hour period. The study conditions for each session (i.e., heater resistance and nicotine combinations) will be Latin-square ordered.
| Study group | Role | What they receive |
|---|---|---|
| ECIG Session: 0.5 Ohms, 3 mg | Experimental | Heating coil resistance 0.5 Ohms Liquid nicotine concentration 3 mg Receives: Other: ECIG Session |
| ECIG Session 0.5 Ohms, 8 mg | Experimental | Heating coil resistance 0.5 Ohms Liquid nicotine concentration 8 mg Receives: Other: ECIG Session |
| ECIG Session 1.5 Ohms, 3 mg | Experimental | Heating coil resistance 1.5 Ohms Liquid nicotine concentration 3 mg Receives: Other: ECIG Session |
| ECIG Session 1.5 Ohms, 8 mg | Experimental | Heating coil resistance 1.5 Ohms Liquid nicotine concentration 8 mg Receives: Other: ECIG Session |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax: Plasma nicotine concentration (ng/ml)
Measured: Six blood samples are collected at each of the 4 visits. During each session, blood samples are collected 90,100,160,185,205,225 minutes into the session which lasts approximately 4 hours.
Secondary outcomes (9)
Withdrawal suppression: Hughes-Hatsukami Withdrawal Scale
Contains 11 items. Administered on a computerized visual analogue scale that consists of a phrase centered on a horizontal line with "not at all" on the left and "extremely" on the right.. Responses range from 0-100.
Measured: Collected six times at each of the 4 visits. During each session, questions are collected 90,100,160,185,205,225 minutes into the session which lasts approximately 4 hours.
Withdrawal suppression: Direct effects of nicotine scale
Contains 9-items. Administered on a computerized visual analogue scale that consists of a phrase centered on a horizontal line with "not at all" on the left and "extremely" on the right.. Responses range from 0-100.
Measured: Collected six times at each of the 4 visits. During each session, questions are collected 90,100,160,185,205,225 minutes into the session which lasts approximately 4 hours.
Withdrawal suppression: Tiffany Drobes Questionnaire of Smoking Urges
Contains 10 items. Participants will be asked to rate each phrase on a 7-point scale ranging from 0 (Strongly disagree) to 7 (Strongly agree). The items from this scale will form two factors: Factor 1 (intention to smoke) and Factor 2 (anticipation of relief from abstinence symptoms).
Measured: Collected six times at each of the 4 visits. During each session, questions are collected 90,100,160,185,205,225 minutes into the session which lasts approximately 4 hours.
Withdrawal suppression: Direct effects of ECIG use scale
Contains 14-items. Administered on a computerized visual analogue scale that consists of a phrase centered on a horizontal line with "not at all" on the left and "extremely" on the right. Responses range from 0-100.
Measured: Collected six times at each of the 4 visits. During each session, questions are collected 90,100,160,185,205,225 minutes into the session which lasts approximately 4 hours.
Other subjective effects: General Labeled Magnitude Scale
Contains 4-items. This category-ratio scale contains seven semantic labels that increase in sensitivity including: "no sensation", "barely detectable", "weak", "moderate", "strong", "very strong", and "strongest imaginable sensation of any kind." Responses will be coded on a 0-100 scale.
Measured: Collected six times at each of the 4 visits. During each session, questions are collected 90,100,160,185,205,225 minutes into the session which lasts approximately 4 hours.
Other subjective effects: Labeled Hedonic Scale
Contains 4-items. This category-ratio scale contains ten semantic labels, intended to assess participant liking or disliking of sensations experienced in the general labeled magnitude scale.. Semantic labels include: "most liked sensation imaginable", "like extremely", "like very much", "like moderately", "like slightly", "dislike slightly", "dislike moderately", "dislike very much", "dislike extremely" and "most disliked sensation imaginable". Responses will be coded on a 0-100 scale.
Measured: Collected six times at each of the 4 visits. During each session, questions are collected 90,100,160,185,205,225 minutes into the session which lasts approximately 4 hours.
Puff Topography: puff duration
Puff duration is the measurement of the length of participant puffs in seconds during a 10-puff directed puffing bout (lasting 5-minutes) and during the 60-minute ad libitum bout where participants are instructed to puff as much or as little as they like on the ECIG.
Measured: Collected twice at each of the 4 visits. During each session, puff duration is measured at 95 and 225 minutes.
Puff Topography: puff volume
Puff volume is the measurement of the size of participant puffs in milliliters during a 10-puff directed puffing bout (lasting 5-minutes) and during the 60-minute ad libitum bout where participants are instructed to puff as much or as little as they like on the ECIG.
Measured: Collected twice at each of the 4 visits. During each session, puff duration is measured at 95 and 225 minutes.
Puff Topography: puff velocity
Puff velocity is the measurement of the speed of participant puffs in milliliters per second during a 10-puff directed puffing bout (lasting 5-minutes) and during the 60-minute ad libitum bout where participants are instructed to puff as much or as little as they like on the ECIG.
Measured: Collected twice at each of the 4 visits. During each session, puff duration is measured at 95 and 225 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2018
- Study start21 May 2018
- Primary completion17 Dec 2018
- Study completion17 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nicotine DependenceStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas E Eissenberg, PhD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03496116
- Sponsor's protocol ID
- HM20012671
- Status last verified
- May 2019
- First submitted
- 2 Apr 2018
- Last updated
- 9 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Electronic Cigarette Heater Resistance on Nicotine Delivery, Heart Rate, Subjective Effects and Puff Topography
- ClinicalTrials.gov ID
- NCT03496116
- Acronym / sponsor ID
- HM20012671
- Conditions
- Nicotine Dependence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 21 May 2018 (actual)
- Primary completion
- 17 Dec 2018 (actual)
- Study completion
- 17 Dec 2018 (actual)
- First posted
- 12 Apr 2018 (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 purpose of this study is to measure the individual and combined influence of electronic cigarette (ECIG) heating element resistance and liquid nicotine concentration on ECIG acute effects. Thirty-two experienced ECIG users will complete four independent laboratory sessions that will differ by heater resistance (0.5 ohm or 1.5 ohm) and liquid nicotine concentration (3 or 8 mg/ml). Other factors such as voltage, liquid solvent ratio, and liquid flavor will be held constant. Plasma nicotine concentration, subjective effects, and puffing behavior will be recorded for each condition.
Detailed description
Electronic cigarettes (ECIGs) are a popular and rapidly evolving class of products. ECIG users can manipulate several device features including liquid nicotine concentration (mg/ml) and heating element resistance (ohms). An emerging class of ECIG models includes "sub-Ohm" devices that employ low resistance heaters that are often used to achieve high device power. Some clinical laboratory data suggest that high power devices deliver nicotine to the user effectively, even when paired with a low liquid nicotine concentration. However, given that ECIG heater resistance and liquid nicotine concentration have not been manipulated in clinical laboratory studies, the influence of these factors on ECIG acute effects remain unclear. The purpose of this clinical laboratory study is to measure the influence of heater resistance and liquid nicotine concentration on ECIG acute effects. Participants will attend the lab for four experimental sessions where they use an ECIG. For each session, the participants will be randomly assigned (like the flip of a coin) to receive an ECIG with one of two different levels of heating coil resistance (which will determine overall device power) and one of two different liquid nicotine concentrations. The four sessions will begin at approximately the same time each day, will be separated by at least 48 hours, and will not occur more than two times per week. The primary hypotheses are that the low resistance heater paired with the 8 mg/ml liquid nicotine concentration, will result in greater nicotine delivery and subjective effect profiles, suggestive of higher abuse potential. Results from this study will further our understanding of the factors that influence the dependence potential of ECIGs and could inform future regulation of these devices.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ECIG Session: 0.5 Ohms, 3 mg | Experimental | Other: ECIG SessionHeating coil resistance 0.5 Ohms Liquid nicotine concentration 3 mg |
| ECIG Session 0.5 Ohms, 8 mg | Experimental | Other: ECIG SessionHeating coil resistance 0.5 Ohms Liquid nicotine concentration 8 mg |
| ECIG Session 1.5 Ohms, 3 mg | Experimental | Other: ECIG SessionHeating coil resistance 1.5 Ohms Liquid nicotine concentration 3 mg |
| ECIG Session 1.5 Ohms, 8 mg | Experimental | Other: ECIG SessionHeating coil resistance 1.5 Ohms Liquid nicotine concentration 8 mg |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Willing to provide informed consent, attend the lab and abstain from nicotine/tobacco as required, and use designated products according to study protocol
- Experienced ECIG users (use ≥1 ml of ECIG solution daily, use ECIG solution with a nicotine concentration ≥3 mg/ml, and have used their ECIG for ≥3 months)
- Urine cotinine test result ≥ 3
Key exclusion criteria (7 listed)
- History of organ-related diseases or current psychiatric condition
- Regular use of prescription medication other than vitamins or birth control
- Past month use of cocaine, opioids, benzodiazepines, or methamphetamine
- Using marijuana greater than 10 days in the past 30 and/or alcohol greater than 25 days in the past 30 days
- Pregnant or breastfeeding women
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 SessionParticipants will complete four sessions using an e-cigarette, including a 10-puff product use bout followed by a 60-minute ad lib bout over an approximately 4-hour period. The study conditions for each session (i.e., heater resistance and nicotine combinations) will be Latin-square ordered. | Other | ECIG Session 0.5 Ohms, 8 mg, ECIG Session 1.5 Ohms, 3 mg, ECIG Session 1.5 Ohms, 8 mg, ECIG Session: 0.5 Ohms, 3 mg |
Primary outcome
Cmax: Plasma nicotine concentration (ng/ml)
Time frame: Six blood samples are collected at each of the 4 visits. During each session, blood samples are collected 90,100,160,185,205,225 minutes into the session which lasts approximately 4 hours.
9 secondary outcomes
Withdrawal suppression: Hughes-Hatsukami Withdrawal Scale
Time frame: Collected six times at each of the 4 visits. During each session, questions are collected 90,100,160,185,205,225 minutes into the session which lasts approximately 4 hours.
Withdrawal suppression: Direct effects of nicotine scale
Time frame: Collected six times at each of the 4 visits. During each session, questions are collected 90,100,160,185,205,225 minutes into the session which lasts approximately 4 hours.
Withdrawal suppression: Tiffany Drobes Questionnaire of Smoking Urges
Time frame: Collected six times at each of the 4 visits. During each session, questions are collected 90,100,160,185,205,225 minutes into the session which lasts approximately 4 hours.
Withdrawal suppression: Direct effects of ECIG use scale
Time frame: Collected six times at each of the 4 visits. During each session, questions are collected 90,100,160,185,205,225 minutes into the session which lasts approximately 4 hours.
Other subjective effects: General Labeled Magnitude Scale
Time frame: Collected six times at each of the 4 visits. During each session, questions are collected 90,100,160,185,205,225 minutes into the session which lasts approximately 4 hours.
Other subjective effects: Labeled Hedonic Scale
Time frame: Collected six times at each of the 4 visits. During each session, questions are collected 90,100,160,185,205,225 minutes into the session which lasts approximately 4 hours.
Puff Topography: puff duration
Time frame: Collected twice at each of the 4 visits. During each session, puff duration is measured at 95 and 225 minutes.
Puff Topography: puff volume
Time frame: Collected twice at each of the 4 visits. During each session, puff duration is measured at 95 and 225 minutes.
Puff Topography: puff velocity
Time frame: Collected twice at each of the 4 visits. During each session, puff duration is measured at 95 and 225 minutes.
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 9 May 2019.
- Individual participant dataSharing planned: Undecided
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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.
Thomas E Eissenberg, PhD 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 study testing ECIG Session in people with Nicotine Dependence, 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 3 inclusion and 7 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 9 May 2019. 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.
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?
Cmax: Plasma nicotine concentration (ng/ml) (time frame: Six blood samples are collected at each of the 4 visits. During each session, blood samples are collected 90,100,160,185,205,225 minutes into the session which lasts approximately 4 hours.). 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 9 May 2019.