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

NCT02964182 | Completed Results DMC FDA Device

• 4 other identifiers: 2015-0638NCI-2019-02501National Cancer InstituteR01DA042526
• Study Type: interventional
• Target: 213
• Locations: 1 country
• Sites: 1

Brief 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 in smoking behavior in current daily and intermittent smokers..

Conditions

Tobacco-Related Carcinoma; Cigarette Smoking-Related Carcinoma

Outcome Measures

Primary Outcomes (3)

• Usual Brand Cigarettes Per Day

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

  One to three weeks

• Very Low Nicotine Content Cigarettes Per Day

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

  One to three weeks

• 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

  One to three weeks

Study Arms (2)

Arm I (usual cigarettes, VLNCC, ECIG-Hi, ECIG-Lo)

EXPERIMENTAL

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

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)

EXPERIMENTAL

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

Drug: Cigarette; Drug: Nicotine Replacement; Other: Questionnaire Administration; Other: Survey Administration; Drug: Very Low Nicotine Content Cigarette; Device: ECIG-Hi; Device: ECIG-Lo

Interventions

Cigarette DRUG

Smoke usual brand of cigarettes

Arm I (usual cigarettes, VLNCC, ECIG-Hi, ECIG-Lo); Arm II (usual cigarettes, VLNCC, ECIG-Hi, ECIG-Lo)

Nicotine Replacement DRUG

Received NRT (Electronic Cigarette - ECIG-Hi)

Also known as: Nicotine Replacement Therapy, NRT

Arm I (usual cigarettes, VLNCC, ECIG-Hi, ECIG-Lo)

Questionnaire Administration OTHER

Ancillary studies

Arm I (usual cigarettes, VLNCC, ECIG-Hi, ECIG-Lo); Arm II (usual cigarettes, VLNCC, ECIG-Hi, ECIG-Lo)

Survey Administration OTHER

Ancillary studies

Arm I (usual cigarettes, VLNCC, ECIG-Hi, ECIG-Lo); Arm II (usual cigarettes, VLNCC, ECIG-Hi, ECIG-Lo)

Very Low Nicotine Content Cigarette DRUG

Smoke very low nicotine content cigarette

Also known as: VLNCC

Arm I (usual cigarettes, VLNCC, ECIG-Hi, ECIG-Lo); Arm II (usual cigarettes, VLNCC, ECIG-Hi, ECIG-Lo)

ECIG-Hi DEVICE

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

Arm I (usual cigarettes, VLNCC, ECIG-Hi, ECIG-Lo); Arm II (usual cigarettes, VLNCC, ECIG-Hi, ECIG-Lo)

ECIG-Lo DEVICE

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

Arm I (usual cigarettes, VLNCC, ECIG-Hi, ECIG-Lo); Arm II (usual cigarettes, VLNCC, ECIG-Hi, ECIG-Lo)

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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)
• 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:

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• M D Anderson Cancer Center

MeSH Terms

Interventions

Tobacco Products; Nicotine Replacement Therapy

Intervention Hierarchy (Ancestors)

Smoking Devices; Manufactured Materials; Technology, Industry, and Agriculture; Drug Therapy; Therapeutics

Results Point of Contact

• Title: Jason Robinson, PhD
• Organization: MD Anderson Cancer Center

nicotinestudy@mdanderson.org

713-792-2265

Study Officials

• Paul Cinciripini

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2016
• First Posted: November 16, 2016
• Study Start: October 26, 2017
• Primary Completion: March 4, 2025
• Study Completion: March 4, 2025
• Last Updated: December 9, 2025
• Results First Posted: December 9, 2025

Record last verified: 2025-11

Locations

US (1)