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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

No Placebo-Only Group

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:

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I am using a reliable birth control method if I can become pregnant.

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I have had heart issues like abnormal rhythms or a heart attack in the last 3 months.

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I have used tobacco products other than cigarettes or little cigars on 10 or more days in the last month.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 10 weeks

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.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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