← Back to Search

Electronic Cigarette

Very Low Nicotine Cigarettes + E-Cigarettes for Smoking Cessation

N/A
Waitlist Available
Led By Paul Cinciripini
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
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
Self-reported abnormal heart rhythms or cardiovascular disease (stroke, chest pain, heart attack) in the last 3 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 10 weeks
Awards & highlights

Summary

This trial is testing how different levels of nicotine in cigarettes and e-cigarettes affects smokers trying to quit. They're looking at things like withdrawal symptoms, cravings, and mood to see how easy it is to quit smoking.

Who is the study for?
This trial is for daily and intermittent cigarette smokers who are interested in trying novel nicotine products. Participants must be able to follow instructions in English, have only one person per household join, and can receive mail and do telehealth visits. They cannot use other e-cigarettes or smoking cessation meds recently, have severe respiratory issues, unstable medical conditions, certain mental health diagnoses, or be pregnant/breastfeeding without birth control.
What is being tested?
The study tests the effects of greatly reduced nicotine levels in cigarettes versus electronic cigarettes with varying nicotine content on smoker behavior. It aims to see how these changes affect withdrawal symptoms, cravings for nicotine, mood swings, and overall smoking habits among current smokers.
What are the potential side effects?
While not explicitly listed here, potential side effects may include typical reactions to reducing nicotine intake such as increased cravings for tobacco products; irritability; difficulty concentrating; sleep disturbances; increased appetite leading to weight gain; and possible dependence on the e-cigarette products provided.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am using a reliable birth control method if I can become pregnant.
Select...
I have had heart issues like abnormal rhythms or a heart attack in the last 3 months.
Select...
I have used tobacco products other than cigarettes or little cigars on 10 or more days in the last month.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
To characterize the effects of switching to VLNCCs plus ECIG-Hi or ECIG-Lo nicotine doses on abuse liability among daily and intermittent smokers.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm II (usual cigarettes, VLNCC, ECIG-Hi, ECIG-Lo)Experimental Treatment7 Interventions
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.
Group II: Arm I (usual cigarettes, VLNCC, ECIG-Hi, ECIG-Lo)Experimental Treatment7 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cigarette
2017
Completed Phase 1
~310
Nicotine Replacement
2019
Completed Phase 2
~420

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,039 Previous Clinical Trials
1,799,321 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,543 Previous Clinical Trials
3,248,996 Total Patients Enrolled
Paul CinciripiniPrincipal InvestigatorM.D. Anderson Cancer Center
3 Previous Clinical Trials
2,641 Total Patients Enrolled

Media Library

Electronic Cigarette (Electronic Cigarette) Clinical Trial Eligibility Overview. Trial Name: NCT02964182 — N/A
Cancer Research Study Groups: Arm I (usual cigarettes, VLNCC, ECIG-Hi, ECIG-Lo), Arm II (usual cigarettes, VLNCC, ECIG-Hi, ECIG-Lo)
Cancer Clinical Trial 2023: Electronic Cigarette Highlights & Side Effects. Trial Name: NCT02964182 — N/A
Electronic Cigarette (Electronic Cigarette) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02964182 — N/A
~37 spots leftby Jun 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top