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Cigarette Smoking-Related CarcinomaNCT02964182

Very Low Nicotine Content Cigarettes and E-Cigarettes in Promoting Smoking Cessation in Daily and Intermittent Cigarette Smokers

A study testing Cigarette, Nicotine Replacement and Questionnaire Administration in people with Cigarette Smoking-Related Carcinoma and Tobacco-Related Carcinoma, run by M.D. Anderson Cancer Center at 1 site 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

This trial studies what would happen if the nicotine levels in cigarettes are greatly reduced, but electronic cigarettes containing different amount of nicotine are available. Different levels of nicotine may effect certain behaviors, including withdrawal symptoms, nicotine cravings, and mood and may lead to changes… Read more about this study

Who is it for?
Ages 21 to 65 yearsHealthy volunteers can take part
What is being tested?
Cigarette, Nicotine Replacement and Questionnaire Administration
Could I receive a placebo?
No, everyone receives an active treatment
How many people
213 participants
Where
1 siteUnited States
Study dates
26 Oct 2017to 4 Mar 2025
Phase
Interventional

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

  • Sign consent and agree to all study procedures
  • Have an address where he/she can receive mail
  • Have a device available to conduct telehealth visit (e.g., smartphone, computer, tablet, internet access, etc.)
  • Able to follow verbal and written instructions in English
  • Willing and able to complete two spirometry sessions (this criterion waived during COVID-19 pandemic)
  • Be the only participant in their household
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  • Interested in trying novel nicotine products
  • Daily smokers: >= 1 cigarette/little cigar per day
  • Intermittent smokers: >= 1 cigarette/little cigar per day 4 to 27 days per month
  • Agrees to comply with all MD Anderson institutional policies related to COVID-19 screening prior to each in-person research visit
  • The individual agrees to not engage in study procedures or interactions with study personnel while operating a vehicle

Who cannot join

  • Unwilling to refrain from other e-cigarette use for the duration of the study, other than what is provided to them for study purposes
  • Current/recent use of certain medications:
  • Smoking cessation meds (past 90 days; e.g., wellbutrin, bupropion, Zyban, nicotine replacement therapy [NRT], Chantix)
  • Certain medications to treat depression (last 14 days; e.g., amitriptyline)
  • A case by case determination will be made by study physician for medication on the precautionary list, (e.g. nitroglycerin)
  • Self-reported daily use of opioids for 30 days or more on phone screen or at screening is exclusionary however pro re nata (PRN) use is allowed (e.g., 3 to 7 days per week or less or if more frequent, use less than a month's duration
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  • Unstable medical condition as determined by the medical team
  • Self-reported bronchial or respiratory infection in the last 14 days (this criterion waived during COVID-19 pandemic)
  • Subject's spirometry forced expiratory volume in 1 second (FEV1) percentage reading is < 50 (severe to very severe obstruction) (this criterion waived during COVID-19 pandemic)
  • Self-reported abnormal heart rhythms or cardiovascular disease (stroke, chest pain, heart attack) in the last 3 months
  • Meet criteria for major depressive syndrome or suicidality on the Patient Health Questionnaire-9 (PHQ-9)
  • Self report of past or current diagnosis of bi-polar disorder or schizophrenia/schizoaffective disorder
  • Self-reported other tobacco use besides cigarettes or little cigars (e.g., hookah, cigarillos, smokeless tobacco, chewing tobacco, pipes, cigars, etc.) on 10 or more days in the last month
  • Recent (past 90 days), current, or planned (within the next 45 days) involvement in smoking cessation activities
  • Positive urine pregnancy test at screening. Women who are two years post-menopausal, or who have had a tubal ligation or a partial or full hysterectomy will not be subject to a urine pregnancy test
  • Women that are breastfeeding or of childbearing potential and not protected by a medically acceptable, effective method of birth control while enrolled in the study. Medically acceptable contraceptives include:
  • Approved hormonal contraceptives (such as birth control pills, patches, implants or injections)
  • Barrier methods (such as condom or diaphragm) used with a spermicide, or
  • An intrauterine device (IUD)
  • Contraceptives sold for emergency use after unprotected sex are not acceptable methods for routine use
  • Subject considered by the investigator to be unsuitable to participate in the study (e.g., due to cognitive deficits or instability to last the entire duration of the study)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • M D Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: Evaluating Concomitant Use of Very Low Nicotine Content Cigarettes and E-Cigarettes Among Daily and Non-Daily Smokers

This trial studies what would happen if the nicotine levels in cigarettes are greatly reduced, but electronic cigarettes containing different amount of nicotine are available. Different levels of nicotine may effect certain behaviors, including withdrawal symptoms, nicotine cravings, and mood and may lead to changes in smoking behavior in current daily and intermittent smokers..

Read the detailed description

PRIMARY OBJECTIVES:

  1. To characterize the effects of switching to VLNCCs plus ECIG-Hi or ECIG-Lo nicotine doses on abuse liability among daily and intermittent smokers.

EXPLORATORY OBJECTIVES:

  1. To explore the effects of switching to VLNCCs plus ECIG-Hi or ECIG-Lo nicotine doses on abuse liability using biochemical measures of product use, compensation, and toxicant exposure, and self-reported measures of withdrawal, craving, affect, and satisfaction.

II. To explore the effects of switching from usual-brand cigarettes to VLNCCs, and from VLNCCs to VLNCC+ECIGs on measures of abuse liability.

III. To characterize the effects of dual use of VLNCC and JUUL ECIGs on abuse liability.

OUTLINE:

PHASE I: Patients smoke their usual cigarettes brand during week 1.

PHASE II: Patients smoke VLNCC cigarettes provided during weeks 2-4.

PHASES III-IV: Patients are randomized to 1 of 2 arms.

ARM I: Patients smoke ECIG-high (Hi) for 3 weeks and then ECIG-low (Lo) for 3 weeks

ARM II: Patients smoke ECIG-Lo for 3 weeks and then ECIG-Hi for 3 weeks.

After completion of study, patients are followed up for 30 days.

Being tested
Cigarette, Nicotine Replacement, Questionnaire Administration, Survey Administration, Very Low Nicotine Content Cigarette

What participants receive

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

  • CigaretteDrug

    Smoke usual brand of cigarettes

  • Nicotine ReplacementDrug

    Also called Nicotine Replacement Therapy, NRT

    Received NRT (Electronic Cigarette - ECIG-Hi)

  • Nicotine ReplacementDrug

    Also called Nicotine Replacement Therapy, NRT

    Received NRT (Electronic Cigarette - ECIG-Hi)

  • Questionnaire AdministrationOther

    Ancillary studies

  • Survey AdministrationOther

    Ancillary studies

  • Very Low Nicotine Content CigaretteDrug

    Also called VLNCC

    Smoke very low nicotine content cigarette

  • ECIG-HiDevice

    Patients smoke ECIG-Hi for 3 weeks and then ECIG-Lo for 3 weeks.

  • ECIG-LoDevice

    Patients smoke ECIG-Lo for 3 weeks and then ECIG-Hi for 3 weeks

Study groups in NCT02964182
Study groupRoleWhat they receive
Arm I (usual cigarettes, VLNCC, ECIG-Hi, ECIG-Lo)ExperimentalPHASE I: Patients smoke their usual cigarettes brand during week 1. PHASE II: Patients smoke VLNCC cigarettes provided during weeks 2-4. PHASES III-IV: Patients smoke ECIG-Hi for 3 weeks and then ECIG-Lo for 3 weeks.
Receives: Drug: Cigarette; Drug: Nicotine Replacement; Other: Questionnaire Administration; Other: Survey Administration; Drug: Very Low Nicotine Content Cigarette; Device: ECIG-Hi; Device: ECIG-Lo
Arm II (usual cigarettes, VLNCC, ECIG-Hi, ECIG-Lo)ExperimentalPHASE I: Patients smoke their usual cigarettes brand during week 1. PHASE II: Patients smoke VLNCC cigarettes provided during weeks 2-4. PHASES III-IV: Patients smoke ECIG-Lo for 3 weeks and then ECIG-Hi for 3 weeks.
Receives: Drug: Cigarette; Drug: Nicotine Replacement; Other: Questionnaire Administration; Other: Survey Administration; Drug: Very Low Nicotine Content Cigarette; Device: ECIG-Hi; Device: ECIG-Lo

What is being measured

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

  1. Usual Brand Cigarettes Per Day

    Mean usual brand cigarettes per day (CPD) smoked during the phase

    Measured: One to three weeks

  2. Very Low Nicotine Content Cigarettes Per Day

    Mean very low nicotine content cigarettes per day (CPD) smoked during the phase

    Measured: One to three weeks

  3. Total Nicotine Equivalents (TNE)

    Geometric means of the natural log of total nicotine equivalents (TNE), calculated as the sum of total nicotine, total cotinine, total 3'-hydroxycotinine and nicotine N-oxide excreted in urine

    Measured: One to three weeks

Timeline

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

  1. First posted16 Nov 2016 (estimated)
  2. Study start26 Oct 2017
  3. Primary completion4 Mar 2025
  4. Study completion4 Mar 2025

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
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
213 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02964182
Sponsor's protocol ID
2015-0638
Other IDs
NCI-2019-02501, 2015-0638, National Cancer Institute, R01DA042526
Status last verified
Nov 2025
First submitted
11 Nov 2016
Last updated
9 Dec 2025
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

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