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E-cigarettes + Varenicline for Smoking Cessation
Phase 3
Recruiting
Led By Nicole Nollen, 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 week 12 post randomization
Awards & highlights
Study Summary
This trial aims to compare the effects of nicotine salt pod-based e-cigarettes in African American smokers and assess if harm reduction can be increased by using varenicline.
Who is the study for?
This trial is for African American smokers over 21 years old who smoke more than 5 cigarettes a day and have been smoking for over 6 months. They must be willing to try varenicline, switch to e-cigarettes, and attend all study visits. People can't join if they're trying to quit smoking, have uncontrolled high blood pressure or recent heart issues, certain medical conditions like kidney problems or seizures, are pregnant/breastfeeding, planning to move away soon, using other tobacco products recently or another household member is in the study.Check my eligibility
What is being tested?
The trial aims to see if switching from regular cigarettes to nicotine salt pod-based e-cigarettes reduces harm and addiction potential among African American smokers. It also tests whether taking varenicline helps dual users (those who use both cigarettes and e-cigarettes) completely stop smoking traditional cigarettes.See study design
What are the potential side effects?
Possible side effects include those related to varenicline such as nausea, sleep disturbances, mood changes; placebo has no active ingredients so fewer side effects expected; e-cigarette use may cause throat irritation or coughing.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 12 post randomization
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12 post randomization
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Reduction in toxicant exposure as measured by NNAL (4- (methylnitrosamino)-1-(3-pyridyl)-1-butanol) .
Secondary outcome measures
Carbon Monoxide (CO) verified 7-day point prevalence abstinence from cigarettes
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Varenicline and electronic cigaretteExperimental Treatment2 Interventions
At the end of the 6-week open label phase, dual users of cigarettes and e-cigarettes will receive 1mg varenicline to take twice daily for 12 weeks. They will also receive an additional 12 weeks of the nicotine salt-based pod system e-cigarette.
Group II: Open label electronic cigaretteExperimental Treatment1 Intervention
All participants will receive an initial 6-week supply of the study electronic cigarette.
Group III: Placebo and electronic cigarettePlacebo Group2 Interventions
At the end of the 6-week open label phase, dual users of cigarettes and e-cigarettes will receive placebo pills to take twice daily for 12 weeks. They will also receive an additional 12 weeks of the nicotine salt-based pod system e-cigarette.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Varenicline Tartrate
2008
Completed Phase 4
~2880
Find a Location
Who is running the clinical trial?
University of Kansas Medical CenterLead Sponsor
463 Previous Clinical Trials
168,770 Total Patients Enrolled
Nicole Nollen, PhDPrincipal InvestigatorUniversity of Kanas Medical Center
3 Previous Clinical Trials
1,264 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My blood pressure is not higher than 180/105.I have not had a heart-related event in the last 30 days.I have used medication to help me stop smoking in the last month.I am 21 years old or older.I am willing to take varenicline and attend all study visits.I am interested in switching to emergency contraception.I don't have heart issues, kidney problems, severe allergies, epilepsy, recent psychiatric hospitalization, or thoughts of harming myself.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo and electronic cigarette
- Group 2: Varenicline and electronic cigarette
- Group 3: Open label electronic cigarette
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Is this clinical experiment currently recruiting participants?
"According to the documentation on clinicaltrials.gov, this medical trial is not actively recruiting participants at present. Originally posted March 6th 2023 and last edited January 19th 2023, there are presently 13 other studies that are open for enrollment."
Answered by AI
To what degree is Varenicline combined with electronic cigarette use detrimental to human health?
"With the collected evidence from this Phase 3 trial, our team has assigned Varenicline and electronic cigarettes a safety rating of 3. This signifies that there is an established record of supporting efficacy as well as numerous trials testifying to their safety."
Answered by AI
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