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E-Cigarette Nicotine Concentration for Smoking Cessation
N/A
Recruiting
Led By Eleanor Leavens, PhD
Research Sponsored by University of Kansas Medical 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2-10 days between visits
Awards & highlights
Study Summary
This trial will be the first to look at how nicotine concentration affects how much nicotine smokers take in, and whether this differs between Black and White smokers.
Who is the study for?
This trial is for non-Hispanic white or African American/Black smokers who've smoked on most days in the last 3 months, haven't used e-cigarettes for over a month, and are willing to switch to e-cigarettes. Participants must not have significant recent health issues like heart problems or drug dependence, be pregnant, or use other tobacco products frequently.Check my eligibility
What is being tested?
The study tests how different nicotine levels in e-cigarettes (1.8% and 5%) affect smoking behavior and nicotine intake among participants. They'll try various sequences of these concentrations over six weeks to see if they smoke less or switch completely to vaping.See study design
What are the potential side effects?
While specific side effects aren't listed here, common ones related to e-cigarette use may include throat irritation, coughing, dry mouth, dizziness due to nicotine intake variations during the trial.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2-10 days between visits
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2-10 days between visits
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Total inhaled volume
Trial Design
16Treatment groups
Experimental Treatment
Group I: 9 White 1-10 Cigarettes per day Electronic Cigarette Nicotine Concentration 1.8% 5% 1.8%Experimental Treatment1 Intervention
9, White, baseline smoking at enrollment is 1-10 cigarettes per day.
At lab visit 1 participants receive 1.8% electronic cigarette pod nicotine concentration during the 10-puff standardized puff bout and 60-minute ad libitum session.
After a washout period of at least 48 hours, at lab visit 2 participants receive 5% electronic cigarette pod nicotine concentration during the 10-puff standardized puff bout and 60-minute ad libitum session.
After a washout period of at least 7 days, during phase two, participants received 1.8% electronic cigarette pod nicotine concentration for 6 weeks of home use.
Group II: 8 African America 11-30 Cigarettes per day Electronic Cigarette Nicotine Concentration 5% 1.8% 5%Experimental Treatment1 Intervention
8, African American, baseline smoking at enrollment is 11-30 cigarettes per day.
At lab visit 1 participants receive 5% electronic cigarette pod nicotine concentration during the 10-puff standardized puff bout and 60-minute ad libitum session.
After a washout period of at least 48 hours, at lab visit 2 participants receive 1.8% electronic cigarette pod nicotine concentration during the 10-puff standardized puff bout and 60-minute ad libitum session.
After a washout period of at least 7 days, during phase two, participants received 5% electronic cigarette pod nicotine concentration for 6 weeks of home use.
Group III: 7 African American 11-30 Cigarettes per day Electronic Cigarette Nicotine Concentration 5% 1.8% 1.8%Experimental Treatment1 Intervention
7, African American, baseline smoking at enrollment is 11-30 cigarettes per day.
At lab visit 1 participants receive 5% electronic cigarette pod nicotine concentration during the 10-puff standardized puff bout and 60-minute ad libitum session.
After a washout period of at least 48 hours, at lab visit 2 participants receive 1.8% electronic cigarette pod nicotine concentration during the 10-puff standardized puff bout and 60-minute ad libitum session.
After a washout period of at least 7 days, during phase two, participants received 1.8% electronic cigarette pod nicotine concentration for 6 weeks of home use.
Group IV: 6 African American 11-30 Cigarettes per day Electronic Cigarette Nicotine Concentration 1.8% 5% 5%Experimental Treatment1 Intervention
6, African American, baseline smoking at enrollment is 11-30 cigarettes per day.
At lab visit 1 participants receive 1.8% electronic cigarette pod nicotine concentration during the 10-puff standardized puff bout and 60-minute ad libitum session.
After a washout period of at least 48 hours, at lab visit 2 participants receive 5% electronic cigarette pod nicotine concentration during the 10-puff standardized puff bout and 60-minute ad libitum session.
After a washout period of at least 7 days, during phase two, participants received 5% electronic cigarette pod nicotine concentration for 6 weeks of home use.
Group V: 5 African American 11-30 Cigarettes per day Electronic Cigarette Nicotine Concentration 1.8% 5% 1.8%Experimental Treatment1 Intervention
5, African American, baseline smoking at enrollment is 11-30 cigarettes per day
At lab visit 1 participants receive 1.8% electronic cigarette pod nicotine concentration during the 10-puff standardized puff bout and 60-minute ad libitum session.
After a washout period of at least 48 hours, at lab visit 2 participants receive 5% electronic cigarette pod nicotine concentration during the 10-puff standardized puff bout and 60-minute ad libitum session.
After a washout period of at least 7 days, during phase two, participants received 1.8% electronic cigarette pod nicotine concentration for 6 weeks of home use.
Group VI: 4 African American 1-10 Cigarettes per day Electronic Cigarette Nicotine Concentration 5% 1.8% 5%Experimental Treatment1 Intervention
4, African American, baseline smoking at enrollment is 1-10 cigarettes per day
At lab visit 1 participants receive 5% electronic cigarette pod nicotine concentration during the 10-puff standardized puff bout and 60-minute ad libitum session.
After a washout period of at least 48 hours, at lab visit 2 participants receive 1.8% electronic cigarette pod nicotine concentration during the 10-puff standardized puff bout and 60-minute ad libitum session.
After a washout period of at least 7 days, during phase two, participants received 5% electronic cigarette pod nicotine concentration for 6 weeks of home use.
Group VII: 3 African American 1-10 Cigarettes per day Electronic Cigarette Nicotine Concentration 5% 1.8% 1.8%Experimental Treatment1 Intervention
3, African American, baseline smoking at enrollment is 1-10 cigarettes per day
At lab visit 1 participants receive 5% electronic cigarette pod nicotine concentration during the 10-puff standardized puff bout and 60-minute ad libitum session.
After a washout period of at least 48 hours, at lab visit 2 participants receive 1.8% electronic cigarette pod nicotine concentration during the 10-puff standardized puff bout and 60-minute ad libitum session.
After a washout period of at least 7 days, during phase two, participants received 1.8% electronic cigarette pod nicotine concentration for 6 weeks of home use.
Group VIII: 2 African American 1-10 Cigarettes per day Electronic Cigarette Nicotine Concentration 1.8% 5% 5%Experimental Treatment1 Intervention
2, African American, baseline smoking at enrollment is 1-10 cigarettes per day
At lab visit 1 participants receive 1.8% electronic cigarette pod nicotine concentration during the 10-puff standardized puff bout and 60-minute ad libitum session.
After a washout period of at least 48 hours, at lab visit 2 participants receive 5% electronic cigarette pod nicotine concentration during the 10-puff standardized puff bout and 60-minute ad libitum session.
After a washout period of at least 7 days, during phase two, participants received 5% electronic cigarette pod nicotine concentration for 6 weeks of home use.
Group IX: 16 White 11-30 Cigarettes per day Electronic Cigarette Nicotine Concentration 5% 1.8% 5%Experimental Treatment1 Intervention
16, White, baseline smoking at enrollment is 11-30 cigarettes per day.
At lab visit 1 participants receive 5% electronic cigarette pod nicotine concentration during the 10-puff standardized puff bout and 60-minute ad libitum session.
After a washout period of at least 48 hours, at lab visit 2 participants receive 1.8% electronic cigarette pod nicotine concentration during the 10-puff standardized puff bout and 60-minute ad libitum session.
After a washout period of at least 7 days, during phase two, participants received 5% electronic cigarette pod nicotine concentration for 6 weeks of home use.
Group X: 15 White 11-30 Cigarettes per day Electronic Cigarette Nicotine Concentration 5% 1.8% 1.8%Experimental Treatment1 Intervention
15, White, baseline smoking at enrollment is 11-30 cigarettes per day.
At lab visit 1 participants receive 5% electronic cigarette pod nicotine concentration during the 10-puff standardized puff bout and 60-minute ad libitum session.
After a washout period of at least 48 hours, at lab visit 2 participants receive 1.8% electronic cigarette pod nicotine concentration during the 10-puff standardized puff bout and 60-minute ad libitum session.
After a washout period of at least 7 days, during phase two, participants received 1.8% electronic cigarette pod nicotine concentration for 6 weeks of home use.
Group XI: 14 White 11-30 Cigarettes per day Electronic Cigarette Nicotine Concentration 1.8% 5% 5%Experimental Treatment1 Intervention
14, White, baseline smoking at enrollment is 11-30 cigarettes per day.
At lab visit 1 participants receive 1.8% electronic cigarette pod nicotine concentration during the 10-puff standardized puff bout and 60-minute ad libitum session.
After a washout period of at least 48 hours, at lab visit 2 participants receive 5% electronic cigarette pod nicotine concentration during the 10-puff standardized puff bout and 60-minute ad libitum session.
After a washout period of at least 7 days, during phase two, participants received 5% electronic cigarette pod nicotine concentration for 6 weeks of home use.
Group XII: 13 White 11-30 Cigarettes per day Electronic Cigarette Nicotine Concentration 1.8% 5% 1.8%Experimental Treatment1 Intervention
13, White, baseline smoking at enrollment is 11-30 cigarettes per day.
At lab visit 1 participants receive 1.8% electronic cigarette pod nicotine concentration during the 10-puff standardized puff bout and 60-minute ad libitum session.
After a washout period of at least 48 hours, at lab visit 2 participants receive 5% electronic cigarette pod nicotine concentration during the 10-puff standardized puff bout and 60-minute ad libitum session.
After a washout period of at least 7 days, during phase two, participants received 1.8% electronic cigarette pod nicotine concentration for 6 weeks of home use.
Group XIII: 12 White 1-10 Cigarettes per day Electronic Cigarette Nicotine Concentration 5% 1.8% 5%Experimental Treatment1 Intervention
12, White, baseline smoking at enrollment is 1-10 cigarettes per day.
At lab visit 1 participants receive 5% electronic cigarette pod nicotine concentration during the 10-puff standardized puff bout and 60-minute ad libitum session.
After a washout period of at least 48 hours, at lab visit 2 participants receive 1.8% electronic cigarette pod nicotine concentration during the 10-puff standardized puff bout and 60-minute ad libitum session.
After a washout period of at least 7 days, during phase two, participants received 5% electronic cigarette pod nicotine concentration for 6 weeks of home use.
Group XIV: 11 White 1-10 Cigarettes per day Electronic Cigarette Nicotine Concentration 5% 1.8% 1.8%Experimental Treatment1 Intervention
11, White, baseline smoking at enrollment is 1-10 cigarettes per day.
At lab visit 1 participants receive 5% electronic cigarette pod nicotine concentration during the 10-puff standardized puff bout and 60-minute ad libitum session.
After a washout period of at least 48 hours, at lab visit 2 participants receive 1.8% electronic cigarette pod nicotine concentration during the 10-puff standardized puff bout and 60-minute ad libitum session.
After a washout period of at least 7 days, during phase two, participants received 1.8% electronic cigarette pod nicotine concentration for 6 weeks of home use.
Group XV: 10 White 1-10 Cigarettes per day Electronic Cigarette Nicotine Concentration 1.8% 5% 5%Experimental Treatment1 Intervention
10, White, baseline smoking at enrollment is 1-10 cigarettes per day.
At lab visit 1 participants receive 1.8% electronic cigarette pod nicotine concentration during the 10-puff standardized puff bout and 60-minute ad libitum session.
After a washout period of at least 48 hours, at lab visit 2 participants receive 5% electronic cigarette pod nicotine concentration during the 10-puff standardized puff bout and 60-minute ad libitum session.
After a washout period of at least 7 days, during phase two, participants received 5% electronic cigarette pod nicotine concentration for 6 weeks of home use.
Group XVI: 1 African American 1-10 Cigarettes per day Electronic Cigarette Nicotine Concentration 1.8% 5% 1.8%Experimental Treatment1 Intervention
1, African American, baseline smoking at enrollment is 1-10 cigarettes per day
At lab visit 1 participants receive 1.8% electronic cigarette pod nicotine concentration during the 10-puff standardized puff bout and 60-minute ad libitum session.
After a washout period of at least 48 hours, at lab visit 2 participants receive 5% electronic cigarette pod nicotine concentration during the 10-puff standardized puff bout and 60-minute ad libitum session.
After a washout period of at least 7 days, during phase two, participants received 1.8% electronic cigarette pod nicotine concentration for 6 weeks of home use.
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Who is running the clinical trial?
University of Kansas Medical CenterLead Sponsor
463 Previous Clinical Trials
169,222 Total Patients Enrolled
Eleanor Leavens, PhDPrincipal InvestigatorUniversity of Kansas Medical Center
1 Previous Clinical Trials
22 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had heart or lung problems in the last 3 months.I have been using electronic cigarettes weekly for the last six months.I am currently using medication to help me stop smoking.I haven't been hospitalized or visited the ER for mental health, seizures, stroke, or new heart issues in the last 30 days.I can avoid smoking and vaping for 12 hours before 3 lab visits.I am willing to switch to e-cigarettes for 6 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: 1 African American 1-10 Cigarettes per day Electronic Cigarette Nicotine Concentration 1.8% 5% 1.8%
- Group 2: 11 White 1-10 Cigarettes per day Electronic Cigarette Nicotine Concentration 5% 1.8% 1.8%
- Group 3: 2 African American 1-10 Cigarettes per day Electronic Cigarette Nicotine Concentration 1.8% 5% 5%
- Group 4: 3 African American 1-10 Cigarettes per day Electronic Cigarette Nicotine Concentration 5% 1.8% 1.8%
- Group 5: 6 African American 11-30 Cigarettes per day Electronic Cigarette Nicotine Concentration 1.8% 5% 5%
- Group 6: 4 African American 1-10 Cigarettes per day Electronic Cigarette Nicotine Concentration 5% 1.8% 5%
- Group 7: 5 African American 11-30 Cigarettes per day Electronic Cigarette Nicotine Concentration 1.8% 5% 1.8%
- Group 8: 7 African American 11-30 Cigarettes per day Electronic Cigarette Nicotine Concentration 5% 1.8% 1.8%
- Group 9: 8 African America 11-30 Cigarettes per day Electronic Cigarette Nicotine Concentration 5% 1.8% 5%
- Group 10: 9 White 1-10 Cigarettes per day Electronic Cigarette Nicotine Concentration 1.8% 5% 1.8%
- Group 11: 10 White 1-10 Cigarettes per day Electronic Cigarette Nicotine Concentration 1.8% 5% 5%
- Group 12: 15 White 11-30 Cigarettes per day Electronic Cigarette Nicotine Concentration 5% 1.8% 1.8%
- Group 13: 12 White 1-10 Cigarettes per day Electronic Cigarette Nicotine Concentration 5% 1.8% 5%
- Group 14: 13 White 11-30 Cigarettes per day Electronic Cigarette Nicotine Concentration 1.8% 5% 1.8%
- Group 15: 14 White 11-30 Cigarettes per day Electronic Cigarette Nicotine Concentration 1.8% 5% 5%
- Group 16: 16 White 11-30 Cigarettes per day Electronic Cigarette Nicotine Concentration 5% 1.8% 5%
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any opportunities to enroll in the trial at this time?
"Affirmative, clinicaltrials.gov indicates that this experiment is currently enrolling participants. It was initially published on February 20th of the year 2023 and most recently amended on May 23rd 2021. This study requires 48 patients to be recruited from a single site."
Answered by AI
How many individuals have been recruited into this research project?
"Affirmative. As per the data hosted on clinicaltrials.gov, this medical trial is still actively recruiting patients - initially posted on February 20th of 2022 and last amended on May 23rd of 2022. The study needs 48 participants from 1 location to be enrolled."
Answered by AI
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