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Tobacco UseEarly Phase 1CEVNCT05707871

Cardiovascular Effects of Very Low Nicotine Content Cigarettes

A Early Phase 1 study testing SPECTRUM cigarettes and usual brand of Cigarettes in people with Tobacco Use, run by Wake Forest University Health Sciences at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The study is measuring Cardiovascular effects of very low nicotine content cigarettes on daily and non-daily smokers Read more about this study

Who is it for?
Ages 21 years and olderHealthy volunteers can take part
Conditions the study is for
Tobacco Use
What is being tested?
SPECTRUM cigarettes and usual brand of Cigarettes
Could I receive a placebo?
No, everyone receives an active treatment
How many people
49 participants
Where
1 siteUnited States
Study dates
4 Apr 2023to Dec 2026
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Self-reported cigarette smoking at least once in the past 30 days
  • ≥21 years old
  • Willingness to smoke research cigarettes or usual brand cigarettes during lab visit.
  • Ability to speak, comprehend, and read English sufficiently to complete study procedures

Who cannot join

  • Self-reported diagnosis of cardiovascular diseases like coronary artery disease, stroke, peripheral artery disease, cardiac arrhythmia, pulmonary embolism \& blood clots in legs and arm in the past 3 months
  • Body temperature ≥ 100.4˙F
  • Unstable health conditions interfering with electrocardiogram (ECG) measurements
  • Self-reported diagnosis of hyperthyroidism or thyrotoxicosis
  • Currently pregnant (as indicated by urine pregnancy test at the start of laboratory visit) or breastfeeding.
  • Currently seeking treatment to quit smoking

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Maria Anwar, MS contact

802-922-3343

manwar@wakehealth.edu

United States1 site, 1 recruiting

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

    Maria Anwar, MS, 802-922-3343, manwar@wakehealth.edu

    Recruiting

Other trials in United States

About this study

The study is measuring Cardiovascular effects of very low nicotine content cigarettes on daily and non-daily smokers

Read the detailed description

The FDA is planning regulatory actions to limit nicotine levels in cigarettes as far as it is not reduced to zero. The strategy is designed to reduce the addictiveness of cigarettes. However, nicotine related effects of the cigarettes with reduced nicotine content on various body systems are largely unknown. Following formal implementation of the regulatory policy what cardiovascular effects of reduced nicotine cigarettes, also called very low nicotine content cigarettes (VLNCC) are expected to persist is important to determine. This study will determine the cardiovascular effects of VLNCC such as change in heart rate, autonomic functions and indices of ventricular repolarization in smokers. Participants will be asked to smoke two VLNCC and one normal nicotine content cigarette (NNCC) while we will be recording their electrocardiogram (ECG) to see a change in heart rate, heart rate variability and indices of ventricular repolarization.

Conditions
Tobacco Use
Being tested
SPECTRUM cigarettes, usual brand of Cigarettes
Keywords
Cigarette smoking, Nicotine Content, Cardiovascular Disorders
Medical subject headings
Tobacco Use, Cigarette Smoking, Cardiovascular Diseases

What participants receive

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

  • SPECTRUM cigarettesDrug

    Also called Cigarette Smoke

    SPECTRUM cigarettes have varying amount of nicotine content

  • usual brand of CigarettesOther

    Usual Brand of Cigarettes

Study groups in NCT05707871
Study groupRoleWhat they receive
Usual Brand of CigarettesActive comparatorParticipants will smoke 2-3 cigarettes of their usual brand
Receives: Other: usual brand of Cigarettes
Research Cigarettes (SPECTRUM)ExperimentalParticipants will smoke 1-2 SPECTRUM cigarettes
Receives: Drug: SPECTRUM cigarettes

What is being measured

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

  1. Change in Heart rate - Very Low Nicotine Content Cigarettes (VLNCC)s - NRC102/103(0.5mg nicotine)

    Change in heart rate from pre-exposure to post-exposure for the Very Low Nicotine Content Cigarettes (VLNCC)s - NRC102/103(0.5mg nicotine)

    Measured: Hour 1

  2. Change in Heart rate - Very Low Nicotine Content Cigarettes (VLNCC)s - NRC301/302(2.4mg nicotine)

    Change in heart rate from pre-exposure to post-exposure for the Very Low Nicotine Content Cigarettes (VLNCC)s - NRC301/302(2.4mg nicotine)

    Measured: Hour 1

  3. Change in Heart rate - Normal Nicotine Content Cigarettes (NNCC)s - NRC600/601(15.8mg nicotine)

    Change in heart rate from pre-exposure to post-exposure for the normal nicotine content cigarettes (NNCC)s - NRC600/601(15.8mg nicotine)

    Measured: Hour 1

Secondary outcomes (6)

  1. Change in Heart rate variability(HRV) - Very Low Nicotine Content Cigarettes (VLNCC)s - NRC102/103(0.5mg nicotine)

    Change in measures of heart rate variability (HF, LF, LF/HF, RMSSD = root mean square of standard deviation; SDNN = standard deviation of normal-to-normal intervals, Total power) from pre-exposure to post-exposure for the Very Low Nicotine Content Cigarettes (VLNCC)s

    Measured: Hour 1

  2. Change in Heart rate variability(HRV) - Very Low Nicotine Content Cigarettes (VLNCC)s - NRC301/302(2.4mg nicotine)

    Change in measures of heart rate variability (HF, LF, LF/HF, RMSSD = root mean square of standard deviation; SDNN = standard deviation of normal-to-normal intervals, Total power) from pre-exposure to post-exposure for the Very Low Nicotine Content Cigarettes (VLNCC)s

    Measured: Hour 1

  3. Change in Heart rate variability(HRV) - Normal Nicotine Content Cigarettes (NNCC)s - NRC600/601(15.8mg nicotine)

    Change in measures of heart rate variability (HF, LF, LF/HF, RMSSD = root mean square of standard deviation; SDNN = standard deviation of normal-to-normal intervals, Total power) from pre-exposure to post-exposure for the Normal Nicotine Content Cigarettes (NNCC)s

    Measured: Hour 1

  4. Change in electrocardiogram (ECG) Measures - Very Low Nicotine Content Cigarettes (VLNCC)s - NRC102/103(0.5mg nicotine)

    Measures of ventricular repolarization (Q-T interval, QTc, Tp-e interval)from pre-exposure to post-exposure for the Very Low Nicotine Content Cigarettes (VLNCC)s

    Measured: Hour 1

  5. Change in electrocardiogram (ECG) Measures - Very Low Nicotine Content Cigarettes (VLNCC)s - NRC300/301(2.4mg nicotine)

    Measures of ventricular repolarization (Q-T interval, QTc, Tp-e interval)from pre-exposure to post-exposure for the Very Low Nicotine Content Cigarettes (VLNCC) s

    Measured: Hour 1

  6. Change in electrocardiogram (ECG) Measures - Normal Nicotine Content Cigarettes (NNCC)s - NRC600/601(15.8mg nicotine)

    Measures of ventricular repolarization (Q-T interval, QTc, Tp-e interval)from pre-exposure to post-exposure for the Normal Nicotine Content Cigarettes (NNCC)s

    Measured: Hour 1

Timeline

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

  1. First posted1 Feb 2023
  2. Study start4 Apr 2023
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Single group
Model description
Within Subject
Masking
Single blind
Who is masked
Participant
Enrolment
49 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05707871
Sponsor's protocol ID
IRB00092813
Acronym
CEV
Status last verified
Aug 2026
First submitted
23 Jan 2023
Last updated
28 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Benowitz NL, Henningfield JE. Establishing a nicotine threshold for addiction. The implications for tobacco regulation. N Engl J Med. 1994 Jul 14;331(2):123-5. doi: 10.1056/NEJM199407143310212. No abstract available.

    PubMed 7818638

  • Benowitz NL, Henningfield JE. Reducing the nicotine content to make cigarettes less addictive. Tob Control. 2013 May;22 Suppl 1(Suppl 1):i14-7. doi: 10.1136/tobaccocontrol-2012-050860.

    PubMed 23591498

  • Hatsukami DK, Kotlyar M, Hertsgaard LA, Zhang Y, Carmella SG, Jensen JA, Allen SS, Shields PG, Murphy SE, Stepanov I, Hecht SS. Reduced nicotine content cigarettes: effects on toxicant exposure, dependence and cessation. Addiction. 2010 Feb;105(2):343-55. doi: 10.1111/j.1360-0443.2009.02780.x.

    PubMed 20078491

  • Tachmes L, Fernandez RJ, Sackner MA. Hemodynamic effects of smoking cigarettes of high and low nicotine content. Chest. 1978 Sep;74(3):243-6. doi: 10.1378/chest.74.3.243.

    PubMed 688779

  • Moheimani RS, Bhetraratana M, Peters KM, Yang BK, Yin F, Gornbein J, Araujo JA, Middlekauff HR. Sympathomimetic Effects of Acute E-Cigarette Use: Role of Nicotine and Non-Nicotine Constituents. J Am Heart Assoc. 2017 Sep 20;6(9):e006579. doi: 10.1161/JAHA.117.006579.

    PubMed 28931527

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing SPECTRUM cigarettes and usual brand of Cigarettes in people with Tobacco Use, run by Wake Forest University Health Sciences 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: looking for participants now, as of the sponsor's last update on 28 Aug 2026. 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Maria Anwar, MS (802-922-3343, manwar@wakehealth.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Heart rate - Very Low Nicotine Content Cigarettes (VLNCC)s - NRC102/103(0.5mg nicotine) (time frame: Hour 1). The study lists 3 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 NCT05707871, which also lists 5 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 28 Aug 2026.

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