NontherapeuticPhase 1/2NCT02342795

Randomized Controlled Trial Methods for Novel Tobacco Products Evaluation

A Phase 1/2 study testing e-cigarette and cigarette substitute in people with Nontherapeutic, run by Virginia Commonwealth University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to use Randomized Controlled Trial (RCT) methods to examine the influence of novel tobacco products on biomarkers of toxicant exposure and disease risk, reports of adverse events, and concurrent use of other tobacco products. Read more about this study

Who is it for?: Ages 21 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Nontherapeutic
What is being tested?: e-cigarette and cigarette substitute
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 520 participants
Where: 2 sitesUnited States
Study dates: Jun 2015to Jul 2018
Phase: Phase 1/2
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 21 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Age 21-65
Smoke >9 cigarettes per day for at least 1 year
Smoke regular filtered cigarettes or machine-rolled cigarettes with a filter
CO measurement >9 ppm at baseline
No serious quit attempt in the prior 1 month. This includes use of any FDA approved smoking cessation medication (varenicline, bupropion [used specifically as a quitting aid], patch, gum, lozenge, inhaler, and nasal spray) in the past 1 month as an indication of treatment seeking.
Not planning to quit in the next 6 months

Show all 10Show fewer

Interested in reducing cigarette consumption
Willing to attend visits weekly and monthly over a 9-month period (not planning to move, not planning extended vacation, no planned surgeries)
Read and write in English
Able to understand and consent

Who cannot join

Pregnant and/or nursing women
Unstable or significant medical condition in the past 12 months (Recent heart attack or some other heart conditions, stroke, severe angina including high blood pressure if systolic >159 or diastolic >99 observed during screening).
Immune system disorders, respiratory diseases (exacerbations of asthma or COPD, require oxygen, require oral prednisone), kidney (dialysis) or liver diseases (cirrhosis), or any medical disorder/medication that may affect participant safety or biomarker data.
Use of any non-cigarette nicotine delivery product (pipe, cigar, dip, chew, snus, hookah, ECIGs, strips, sticks) in the past 7 days
Uncontrolled mental illness or substance abuse or inpatient treatment for these in the past 6 months
History of difficulty providing or unwilling to provide blood samples (fainting, poor veins, anxiety)

Show all 12Show fewer

No surgery requiring general anesthesia in the past 6 weeks
Use of an ECIG for 5 or more days in the past 28 days or any use in the past 7 days
Use of marijuana or any illicit drug/prescription drugs for non-medical use daily/almost daily, or weekly in the past 3 months per NIDA Quick Screen
Use of hand-rolled, roll your own cigarettes
Known allergy to propylene glycol or vegetable glycerin
Other member of household is currently participating/participated in the study

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
Center for the Study of Tobacco Products
Richmond, Virginia, 23298

Other trials in United States

About this study

Conditions: Nontherapeutic
Being tested: e-cigarette, cigarette substitute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

e-cigaretteOther
cigarette substituteOther

Study groups in NCT02342795
Study group	Role	What they receive
cigarette substitute	Experimental	The QuitSmart cigarette substitute is a plastic tube that looks like a real cigarette and is designed to provide the same draw resistance as a smoker's usual cigarette. There is no drug delivery with this product. Two cigarette substitutes and a product manual are provided to participants following randomization and replacement products are provided throughout the intervention period (24 weeks). Receives: Other: cigarette substitute
e-cigarette (with 0 mg/ml nicotine)	Experimental	The e-cigarette used will be the EGO e-cigarette (marketed by www.liquidexpress.com). Each participant randomized to an ECIG condition will receive 2 e-cigarette batteries, 1 wall adapter, 1 USB charger, and a user manual. Cartomizers containing 0 mg/ml nicotine will be provided throughout the intervention period (24 weeks). Receives: Other: e-cigarette
e-cigarette (with 8 mg/ml nicotine)	Experimental	The e-cigarette used will be the EGO e-cigarette (marketed by www.liquidexpress.com). Each participant randomized to an ECIG condition will receive 2 e-cigarette batteries, 1 wall adapter, 1 USB charger, and a user manual. Cartomizers containing 8 mg/ml nicotine will be provided throughout the intervention period (24 weeks). Receives: Other: e-cigarette
e-cigarette (with 36 mg/ml nicotine)	Experimental	The e-cigarette used will be the EGO e-cigarette (marketed by www.liquidexpress.com). Each participant randomized to an ECIG condition will receive 2 e-cigarette batteries, 1 wall adapter, 1 USB charger, and a user manual. Cartomizers containing 36 mg/ml nicotine will be provided throughout the intervention period (24 weeks). Receives: Other: e-cigarette

What is being measured

The primary outcome is the main question the study is designed to answer.

urine carcinogen biomarker of exposure, NNAL
changes in NNAL concentration measured at week 0, week 4, week 12, and week 24
Measured: week 24

Secondary outcomes (2)

urine biomarker of nicotine exposure, cotinine
changes in cotinine concentration measured at week 0, week 4, week 12, and week 24
Measured: week 24
blood, urine, and exhaled breath condensate biomarkers of oxidative stress, glutathione and 8 Isoprostanes
changes in oxidative stress biomarker concentrations measured at week 0, week 4, week 12, and week 24
Measured: week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2015Jul 2018

First posted21 Jan 2015 (estimated)
Study startJun 2015
Primary completionJun 2018
Study completionJul 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for NontherapeuticStudies 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 1/2
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Care provider
Enrolment: 520 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02342795
Sponsor's protocol ID: HM20002759
Other IDs: 5P50DA036105-02
Status last verified: Sep 2018
First submitted: 16 Dec 2014
Last updated: 7 Sep 2018
Results posted: No
Data monitoring committee: Yes

Publications

Dahal S, Yingst J, Wang X, Cobb CO, Carrillo M, Hrabovsky S, Bascom R, Lopez AA, Kang L, Maloney S, Halquist M, Foulds J, Veldheer S. Changes in cardiovascular disease risk, lung function and other clinical health outcomes when people who smoke use e-cigarettes to reduce cigarette smoking: an exploratory analysis from a randomised placebo-controlled trial. BMJ Open. 2025 Jun 18;15(6):e098005. doi: 10.1136/bmjopen-2024-098005.
PubMed 40533223
Cobb CO, Budd S, Maldonado G, Imran R, Foulds J, Yingst J, Yen MS, Kang L, Sun S, Hall PB, Chowdhury N, Cohen JE; Randomized Control Trial Methods Workgroup of the Center for the Study of Tobacco Products: Member List. Predictors of attrition in a randomized controlled trial of an electronic nicotine delivery system among people interested in cigarette smoking reduction. Contemp Clin Trials. 2024 Oct;145:107662. doi: 10.1016/j.cct.2024.107662. Epub 2024 Aug 12.
PubMed 39142511
Cobb CO, Foulds J, Yen MS, Veldheer S, Lopez AA, Yingst JM, Bullen C, Kang L, Eissenberg T; Randomised Control Trial Methods Workgroup of the Center for the Study of Tobacco Products. Effect of an electronic nicotine delivery system with 0, 8, or 36 mg/mL liquid nicotine versus a cigarette substitute on tobacco-related toxicant exposure: a four-arm, parallel-group, randomised, controlled trial. Lancet Respir Med. 2021 Aug;9(8):840-850. doi: 10.1016/S2213-2600(21)00022-9. Epub 2021 Apr 12.
PubMed 33857436
Lopez AA, Cobb CO, Yingst JM, Veldheer S, Hrabovsky S, Yen MS, Foulds J, Eissenberg T. A transdisciplinary model to inform randomized clinical trial methods for electronic cigarette evaluation. BMC Public Health. 2016 Mar 3;16:217. doi: 10.1186/s12889-016-2792-8.
PubMed 26941050

Study at a glance

From the registry record, last updated by the sponsor on 7 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized Controlled Trial Methods for Novel Tobacco Products Evaluation
ClinicalTrials.gov ID: NCT02342795
Acronym / sponsor ID: HM20002759
Conditions: Nontherapeutic
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 520 participants (actual)
Lead sponsor: Virginia Commonwealth UniversityUniversity, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA), Penn State University, Food and Drug Administration (FDA)
Study start: Jun 2015 (actual)
Primary completion: Jun 2018 (actual)
Study completion: Jul 2018 (actual)
First posted: 21 Jan 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.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, care provider)
Number of arms: 4

Arm	Type	Receives
cigarette substitute	Experimental	Other: cigarette substituteThe QuitSmart cigarette substitute is a plastic tube that looks like a real cigarette and is designed to provide the same draw resistance as a smoker's usual cigarette. There is no drug delivery with this product. Two cigarette substitutes and a product manual are provided to participants following randomization and replacement products are provided throughout the intervention period (24 weeks).
e-cigarette (with 0 mg/ml nicotine)	Experimental	Other: e-cigaretteThe e-cigarette used will be the EGO e-cigarette (marketed by www.liquidexpress.com). Each participant randomized to an ECIG condition will receive 2 e-cigarette batteries, 1 wall adapter, 1 USB charger, and a user manual. Cartomizers containing 0 mg/ml nicotine will be provided throughout the intervention period (24 weeks).
e-cigarette (with 8 mg/ml nicotine)	Experimental	Other: e-cigaretteThe e-cigarette used will be the EGO e-cigarette (marketed by www.liquidexpress.com). Each participant randomized to an ECIG condition will receive 2 e-cigarette batteries, 1 wall adapter, 1 USB charger, and a user manual. Cartomizers containing 8 mg/ml nicotine will be provided throughout the intervention period (24 weeks).
e-cigarette (with 36 mg/ml nicotine)	Experimental	Other: e-cigaretteThe e-cigarette used will be the EGO e-cigarette (marketed by www.liquidexpress.com). Each participant randomized to an ECIG condition will receive 2 e-cigarette batteries, 1 wall adapter, 1 USB charger, and a user manual. Cartomizers containing 36 mg/ml nicotine will be provided throughout the intervention period (24 weeks).

Who may qualify

Ages: 21 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Age 21-65
Smoke >9 cigarettes per day for at least 1 year
Smoke regular filtered cigarettes or machine-rolled cigarettes with a filter
CO measurement >9 ppm at baseline
No serious quit attempt in the prior 1 month. This includes use of any FDA approved smoking cessation medication (varenicline, bupropion [used specifically as a quitting aid], patch, gum, lozenge, inhaler, and nasal spray) in the past 1 month as an indication of treatment seeking.

Key exclusion criteria (12 listed)

Pregnant and/or nursing women
Unstable or significant medical condition in the past 12 months (Recent heart attack or some other heart conditions, stroke, severe angina including high blood pressure if systolic >159 or diastolic >99 observed during screening).
Immune system disorders, respiratory diseases (exacerbations of asthma or COPD, require oxygen, require oral prednisone), kidney (dialysis) or liver diseases (cirrhosis), or any medical disorder/medication that may affect participant safety or biomarker data.
Use of any non-cigarette nicotine delivery product (pipe, cigar, dip, chew, snus, hookah, ECIGs, strips, sticks) in the past 7 days
Uncontrolled mental illness or substance abuse or inpatient treatment for these in the past 6 months

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
e-cigarette	Other	e-cigarette (with 0 mg/ml nicotine), e-cigarette (with 36 mg/ml nicotine), e-cigarette (with 8 mg/ml nicotine)
cigarette substitute	Other	cigarette substitute

Primary outcome

urine carcinogen biomarker of exposure, NNAL
Time frame: week 24
changes in NNAL concentration measured at week 0, week 4, week 12, and week 24

2 secondary outcomes

urine biomarker of nicotine exposure, cotinine
Time frame: week 24
blood, urine, and exhaled breath condensate biomarkers of oxidative stress, glutathione and 8 Isoprostanes
Time frame: week 24

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 Sep 2018.
Derived from this study: PubMed 40533223Dahal S, Yingst J, Wang X, Cobb CO, Carrillo M, Hrabovsky S, Bascom R, Lopez AA, Kang L, Maloney S, Halquist M, Foulds J, Veldheer S. Changes in cardiovascular disease risk, lung function and other clinical health outcomes when people who smoke use e-cigarettes to reduce cigarette smoking: an exploratory analysis from a randomised placebo-controlled trial. BMJ Open. 2025 Jun 18;15(6):e098005. doi: 10.1136/bmjopen-2024-098005.
Derived from this study: PubMed 39142511Cobb CO, Budd S, Maldonado G, Imran R, Foulds J, Yingst J, Yen MS, Kang L, Sun S, Hall PB, Chowdhury N, Cohen JE; Randomized Control Trial Methods Workgroup of the Center for the Study of Tobacco Products: Member List. Predictors of attrition in a randomized controlled trial of an electronic nicotine delivery system among people interested in cigarette smoking reduction. Contemp Clin Trials. 2024 Oct;145:107662. doi: 10.1016/j.cct.2024.107662. Epub 2024 Aug 12.
Derived from this study: PubMed 33857436Cobb CO, Foulds J, Yen MS, Veldheer S, Lopez AA, Yingst JM, Bullen C, Kang L, Eissenberg T; Randomised Control Trial Methods Workgroup of the Center for the Study of Tobacco Products. Effect of an electronic nicotine delivery system with 0, 8, or 36 mg/mL liquid nicotine versus a cigarette substitute on tobacco-related toxicant exposure: a four-arm, parallel-group, randomised, controlled trial. Lancet Respir Med. 2021 Aug;9(8):840-850. doi: 10.1016/S2213-2600(21)00022-9. Epub 2021 Apr 12.
Derived from this study: PubMed 26941050Lopez AA, Cobb CO, Yingst JM, Veldheer S, Hrabovsky S, Yen MS, Foulds J, Eissenberg T. A transdisciplinary model to inform randomized clinical trial methods for electronic cigarette evaluation. BMC Public Health. 2016 Mar 3;16:217. doi: 10.1186/s12889-016-2792-8.

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 Eissenberg principal investigator

Virginia Commonwealth University

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing e-cigarette and cigarette substitute in people with Nontherapeutic, run by Virginia Commonwealth University 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 10 inclusion and 12 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 Sep 2018. 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.

What does this combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

urine carcinogen biomarker of exposure, NNAL (time frame: week 24). 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 NCT02342795, which also lists 4 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 7 Sep 2018.