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Electronic Cigarette

Switching to E-Cigarettes for Smoking Reduction

N/A

Recruiting

Led By Jason Robinson

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

Willing and able to complete 2 spirometry sessions

Be older than 18 years old

Must not have

Meet criteria for current major depressive disorder or suicidality

Subject's spirometry forced expiratory volume in one second (FEV1) percentage reading is < 50 (severe to very severe obstruction)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up all in-person sessions (weeks 0, 2, 4, and 6)

Awards & highlights

No Placebo-Only Group

Summary

This trial will study potential differences between men and women when switching from regular cigarettes to electronic cigarettes.

Who is the study for?

This trial is for adult smokers who've been smoking at least 5 cigarettes daily for the past month, have a stable address and phone, can follow instructions in English, and are willing to switch to tobacco-flavored e-cigarettes. Pregnant or breastfeeding women, those not using birth control, people with severe lung obstruction or unstable health conditions like uncontrolled diabetes or hypertension cannot join.

What is being tested?

The study aims to understand gender differences when switching from regular cigarettes to electronic ones provided by the research team. Participants will use these e-cigarettes and complete questionnaires while their lung function is tested twice during the study.

What are the potential side effects?

Potential side effects may include nicotine withdrawal symptoms such as cravings, irritability, difficulty concentrating, increased appetite and weight gain. E-cigarette use might also cause throat irritation or coughing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can complete 2 breathing test sessions.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with major depression or have had suicidal thoughts.

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My lung function test shows severe to very severe obstruction.

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I have used tobacco products other than cigarettes more than once a week in the last month.

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I am not pregnant, breastfeeding, and I use birth control.

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I do not have any uncontrolled health conditions like high blood pressure or diabetes.

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I do not have cognitive issues that would prevent me from following the study's requirements.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ all in-person sessions (weeks 0, 2, 4, and 6)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~all in-person sessions (weeks 0, 2, 4, and 6)

This trial's timeline: 3 weeks for screening, Varies for treatment, and all in-person sessions (weeks 0, 2, 4, and 6) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Cigarettes per day (CPD) (Aim 1)

Differences between male or female smokers (Aim 2)

Secondary study objectives

Brief Smoking Consequences Questionnaire-Adult (BSCQ-A)

Change in E-cigarette specific Brief Smoking Consequences Questionnaire-Adult (EC-BSCQ-A)

Change in Expired carbon monoxide (CO)

+13 more

Other study objectives

Moderators and mediators of switching to e-cigarettes (with and without nicotine) from regular cigarettes (Exploratory Aim)

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: E-Cig placebo dose followed by E-Cig nicotine doseExperimental Treatment3 Interventions

Participants will be instructed to smoke their usual brand cigarette as they normally would in weeks 1-2 (Phase I) and to use only the SREC (with or without nicotine) in weeks 3-4 (Phase II) and in weeks 5-6 (Phase III). Participant assignment to SREC type at Phases II and III will be counter-balanced within group, with half of men and women receiving the placebo SREC during Phase II and half during Phase III. Participants will attend 4 laboratory visits with study investigators for 3 hours each over 6 weeks of study participation.

Group II: E-Cig nicotine dose followed by E-Cig placebo doseExperimental Treatment3 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nicotine Replacement

2019

Completed Phase 2

~420

Electronic Cigarette

2021

N/A