Nicotine DependenceNCT02520349
Lab to Real World Assessment of E-cigarette Abuse Liability and Appeal
An observational study of Nicotine Dependence, run by Truth Initiative at 2 sites in United States.
Trial summary
The proposed research is a longitudinal human lab study to examine how measures of abuse liability and product appeal vary by e-cigarette device type, and how these lab assessments may predict subsequent e-cigarette and other tobacco use behavior at 1,3, and 6 months. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Nicotine Dependence
- What is being tested?
- MarkTen and e-Go e-cigarettes
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2016to 31 Aug 2018
- Phase
- Observational
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: A total of 30 community volunteers who currently use 10 or more cigarettes per day and have no immediate plans to quit smoking will be enrolled. Investigators will attempt to recruit an equal number of men and women of diverse racial/ethnic backgrounds. This preliminary study is not intended to address gender or race/ethnic differences.
Who may be able to join
- be between 18-65 years of age;
- reside in the Richmond metro area;
- be proficient in English;
- be interested in trying e-cigarettes, assessed at the initial screening;
- have no immediate plans (in the next 30 days) to quit smoking;
- have an active email address (for online follow-up surveys);
- report current cigarette use (≥10 CPD for ≥1 year). To biochemically confirm cigarette smoking status, eligible participants must have an exhaled carbon monoxide (CO) of ≥15ppm at screening using a Vitalograph CO monitor.
Who cannot join
- Individuals fitting any of the following criteria will not be eligible to participate.
- Individuals who have used e-cigarettes in the past 30 days;
- Individuals who used e-cigarettes more than 5 times in their lives;
- Individuals with uncontrolled or unstable medical or psychiatric conditions;
- Individuals with current or recent (within 6 months) drug/alcohol abuse;
- Individuals who weigh less than 110 lbs;
- Individuals with conditions that would require medical attention during the course of the study (such as hypertension [systolic BP over 140, diastolic BP over 90] or elevated heart rate [over 90 BPM]);
- Women who are currently pregnant/breastfeeding or who have plans to become pregnant.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Virginia Commonwealth University
Richmond, Virginia, 23284
American Legacy Foundation
Washington D.C., District of Columbia, 20001
About this study
The proposed research is a longitudinal human lab study to examine how measures of abuse liability and product appeal vary by e-cigarette device type, and how these lab assessments may predict subsequent e-cigarette and other tobacco use behavior at 1,3, and 6 months. An additional aim is to evaluate e-cigarette safety and tolerability among smokers by device type.
Read the detailed description
The proposed research is a longitudinal human lab study to involving 6 lab visits and 3 follow-up surveys at 1, 3, and 6 months after participants' last lab visit. Investigators will enroll 30 smokers (≥10 cig/day) who have not used e-cigarettes in the past 30 days and have never used e-cigarettes "fairly regularly." After a telephone screening to confirm eligibility, participants will attend Virginia Commonwealth University's (VCU) Clinical Behavioral Pharmacology Laboratory for all lab visits. The specific aims are to:
Aim 1. Examine how measures of abuse liability and product appeal vary by ECIG device type (Markten vs. e-Go).
Aim 2. Compare differences in abuse liability and product appeal between participants' usual brand of tobacco cigarette, Markten, and e-Go.
Aim 3. As an exploratory aim, examine the extent to which measures of abuse liability and product appeal as measured in the lab (including TPPT) predict participants' real-world ECIG use at the 1-, 3-, and 6-month follow-up surveys.
Aim 4. To monitor safety and tolerability the MarkTen and e-Go among smokers.
- Conditions
- Nicotine Dependence
- Being tested
- MarkTen and e-Go e-cigarettes
- 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.
MarkTen and e-Go e-cigarettesDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood nicotine concentration
A phlebotomist will draw 7mL of blood via venipuncture (no catheter) before and after directed tobacco product use at Lab Visits 2-6.
Measured: 3 weeks - before and after product administration
Nicotine withdrawal symptom alleviation
Participants will answer questions about their nicotine withdrawal symptoms (e.g. headache, tired, etc)
Measured: 3 weeks - before and after product administration
Change in subjective tobacco product appeal
Participants will answer questions about the positive and negative physical effects of using the product and how much they like the product.
Measured: 3 weeks - before and after product administration
Change in heart rate
Participants' heart rate (HR) will be monitored continuously during Lab Visits 2-6. Participants will commence physiological data measurement 30 minutes before the start of the directed tobacco use bout to establish a resting HR.
Measured: 3 weeks - before and after product administration
Number of Participants with Adverse Events by ECIG Device Type as a Measure of Safety and Tolerability
A count of the number of participants who report adverse events associated with the study, such as headache, chest pain, cough/sputum, nausea/vomiting, dizziness, confusion/stupor, feeling sick, sore throat, shortness of breath, abdominal pain, pleurisy, blurry vision, and tiredness, by e-cigarette device type.
Measured: 3 weeks - before and after product administration
Change in blood pressure
Participants' blood pressure (BP) will be monitored continuously during Lab Visits 2-6. Participants will commence physiological data measurement 30 minutes before the start of the directed tobacco use bout to establish resting BP.
Measured: 3 weeks - before and after product administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2015 (estimated)
- Study startMay 2016
- Primary completion31 Aug 2018
- Study completion31 Aug 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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Truth Initiative
- Sponsor type
- University, hospital or other
- Collaborators
- Virginia Commonwealth University
- Responsible party
- Principal investigator, Jennifer Pearson, Truth Initiative
- Investigators
- Jennifer Pearson, PhD, Principal investigator, Truth Initiative
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02520349
- Sponsor's protocol ID
- 5K01DA037950
- Status last verified
- Oct 2020
- First submitted
- 6 Aug 2015
- Last updated
- 6 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lab to Real World Assessment of E-cigarette Abuse Liability and Appeal
- ClinicalTrials.gov ID
- NCT02520349
- Acronym / sponsor ID
- 5K01DA037950
- Conditions
- Nicotine Dependence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Truth InitiativeUniversity, hospital or other
- Collaborators
- Virginia Commonwealth University
- Study start
- May 2016 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 11 Aug 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.
The proposed research is a longitudinal human lab study to examine how measures of abuse liability and product appeal vary by e-cigarette device type, and how these lab assessments may predict subsequent e-cigarette and other tobacco use behavior at 1,3, and 6 months. An additional aim is to evaluate e-cigarette safety and tolerability among smokers by device type.
Detailed description
The proposed research is a longitudinal human lab study to involving 6 lab visits and 3 follow-up surveys at 1, 3, and 6 months after participants' last lab visit. Investigators will enroll 30 smokers (≥10 cig/day) who have not used e-cigarettes in the past 30 days and have never used e-cigarettes "fairly regularly." After a telephone screening to confirm eligibility, participants will attend Virginia Commonwealth University's (VCU) Clinical Behavioral Pharmacology Laboratory for all lab visits. The specific aims are to:
Aim 1. Examine how measures of abuse liability and product appeal vary by ECIG device type (Markten vs. e-Go).
Aim 2. Compare differences in abuse liability and product appeal between participants' usual brand of tobacco cigarette, Markten, and e-Go.
Aim 3. As an exploratory aim, examine the extent to which measures of abuse liability and product appeal as measured in the lab (including TPPT) predict participants' real-world ECIG use at the 1-, 3-, and 6-month follow-up surveys.
Aim 4. To monitor safety and tolerability the MarkTen and e-Go among smokers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 30 community volunteers who currently use 10 or more cigarettes per day and have no immediate plans to quit smoking will be enrolled. Investigators will attempt to recruit an equal number of men and women of diverse racial/ethnic backgrounds. This preliminary study is not intended to address gender or race/ethnic differences.
Key inclusion criteria (7 listed)
- be between 18-65 years of age;
- reside in the Richmond metro area;
- be proficient in English;
- be interested in trying e-cigarettes, assessed at the initial screening;
- have no immediate plans (in the next 30 days) to quit smoking;
Key exclusion criteria (8 listed)
- Individuals fitting any of the following criteria will not be eligible to participate.
- Individuals who have used e-cigarettes in the past 30 days;
- Individuals who used e-cigarettes more than 5 times in their lives;
- Individuals with uncontrolled or unstable medical or psychiatric conditions;
- Individuals with current or recent (within 6 months) drug/alcohol abuse;
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 |
|---|---|---|
| MarkTen and e-Go e-cigarettes | Device | – |
Primary outcome
Change in blood nicotine concentration
Time frame: 3 weeks - before and after product administration
A phlebotomist will draw 7mL of blood via venipuncture (no catheter) before and after directed tobacco product use at Lab Visits 2-6.
Nicotine withdrawal symptom alleviation
Time frame: 3 weeks - before and after product administration
Participants will answer questions about their nicotine withdrawal symptoms (e.g. headache, tired, etc)
Change in subjective tobacco product appeal
Time frame: 3 weeks - before and after product administration
Participants will answer questions about the positive and negative physical effects of using the product and how much they like the product.
Change in heart rate
Time frame: 3 weeks - before and after product administration
Participants' heart rate (HR) will be monitored continuously during Lab Visits 2-6. Participants will commence physiological data measurement 30 minutes before the start of the directed tobacco use bout to establish a resting HR.
Number of Participants with Adverse Events by ECIG Device Type as a Measure of Safety and Tolerability
Time frame: 3 weeks - before and after product administration
A count of the number of participants who report adverse events associated with the study, such as headache, chest pain, cough/sputum, nausea/vomiting, dizziness, confusion/stupor, feeling sick, sore throat, shortness of breath, abdominal pain, pleurisy, blurry vision, and tiredness, by e-cigarette device type.
Change in blood pressure
Time frame: 3 weeks - before and after product administration
Participants' blood pressure (BP) will be monitored continuously during Lab Visits 2-6. Participants will commence physiological data measurement 30 minutes before the start of the directed tobacco use bout to establish resting BP.
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 6 Oct 2020.
- Individual participant dataSharing planned: Yes
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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.
Jennifer Pearson, PhD principal investigator
Truth Initiative
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nicotine Dependence, run by Truth Initiative at 2 sites 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 7 inclusion and 8 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 6 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Change in blood nicotine concentration (time frame: 3 weeks - before and after product administration). The study lists 6 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 6 Oct 2020.