Your session is about to expire
← Back to Search
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
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 belowSelect...
I can complete 2 breathing test sessions.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been diagnosed with major depression or have had suicidal thoughts.
Select...
My lung function test shows severe to very severe obstruction.
Select...
I have used tobacco products other than cigarettes more than once a week in the last month.
Select...
I am not pregnant, breastfeeding, and I use birth control.
Select...
I do not have any uncontrolled health conditions like high blood pressure or diabetes.
Select...
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)
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 moreOther study objectives
Moderators and mediators of switching to e-cigarettes (with and without nicotine) from regular cigarettes (Exploratory Aim)
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
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.
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
~1060
Find a Location
Who is running the clinical trial?
National Institute on Drug Abuse (NIDA)NIH
2,543 Previous Clinical Trials
3,249,180 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
3,039 Previous Clinical Trials
1,799,505 Total Patients Enrolled
Jason RobinsonPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
311 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with major depression or have had suicidal thoughts.You are okay with using e-cigarettes that have a tobacco flavor for the study.You are able to follow verbal and written instructions in English and complete all aspects of the study as determined by the PI.I have recently started or plan to start a program to quit smoking soon.My lung function test shows severe to very severe obstruction.I have used tobacco products other than cigarettes more than once a week in the last month.I have not had a lung or breathing infection in the last 2 weeks.I am not pregnant, breastfeeding, and I use birth control.You are open to using electronic cigarettes with a tobacco flavor for the study.I can complete 2 breathing test sessions.I do not have any uncontrolled health conditions like high blood pressure or diabetes.You have used electronic cigarettes on more than two days in the past 30 days.You have been smoking at least 5 cigarettes per day in the last month.I do not have cognitive issues that would prevent me from following the study's requirements.You have smoked at least 5 cigarettes per day in the last month.Produce an expired CO of 5 ppm or more.
Research Study Groups:
This trial has the following groups:- Group 1: E-Cig placebo dose followed by E-Cig nicotine dose
- Group 2: E-Cig nicotine dose followed by E-Cig placebo dose
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Cancer Patient Testimony for trial: Trial Name: NCT03856515 — N/A
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger