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Varenicline for Smoking Cessation
Phase 2
Waitlist Available
Led By Benjamin Toll
Research Sponsored by Yale University
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
Awards & highlights
Study Summary
This trial will test whether varenicline can help people who vape and want to quit smoking cigarettes.
Who is the study for?
This trial is for adults in South Carolina or Connecticut who've been using nicotine e-cigarettes daily for over 6 months and want to quit. They must have a smartphone or email access, not smoke cigarettes, and can't be pregnant (if female under 55), use other quitting aids, or have severe kidney issues.Check my eligibility
What is being tested?
The study tests if Varenicline Tartrate, a medication that helps with cigarette cravings and reduces smoking pleasure, can also help people stop vaping. Participants will either receive Varenicline or a placebo without knowing which one they're taking.See study design
What are the potential side effects?
Varenicline may cause nausea, sleep problems (insomnia/dreams), constipation, gas, vomiting. It has also been associated with mood changes like depression or agitation in some cases.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants Abstinent from vaping at week 8
Secondary outcome measures
Number of participants Abstinent from vaping at week 12
Side effects data
From 2013 Phase 4 trial • 1510 Patients • NCT0137035628%
Nausea
13%
Nasopharyngitis
11%
Abnormal dreams
11%
Insomnia
8%
Upper respiratory tract infection
8%
Headache
7%
Anxiety
6%
Fatigue
5%
Constipation
5%
Irritability
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Varenicline
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Varenicline + Self-Change PamphletExperimental Treatment1 Intervention
Days 1-3: 0.5mg study pill once per day
Days 4-7: 0.5mg study pill twice per day
Weeks 2-8: 1mg study pill twice per day in combination with a minimal, self-guided behavior change booklet. This booklet includes general tips for e-cigarettes cessation and information about the free web-based e-cigarette cessation program sponsored by The Truth Initiative and Mayo called "This is Quitting". This study will have an 8-week treatment period and a 4-week follow-up.
Group II: Placebo + Self-Change PamphletPlacebo Group1 Intervention
Days 1-3: 0.5mg placebo pill once per day
Days 4-7: 0.5mg placebo pill twice per day
Weeks 2-8: 1mg placebo pill twice per day in combination with a minimal, self-guided behavior change booklet. This booklet includes general tips for e-cigarettes cessation and information about the free web-based e-cigarette cessation program sponsored by The Truth Initiative and Mayo called "This is Quitting". This study will have an 8-week treatment period and a 4-week follow-up.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Varenicline Tartrate
2008
Completed Phase 4
~2840
Find a Location
Who is running the clinical trial?
Yale UniversityLead Sponsor
1,847 Previous Clinical Trials
2,736,488 Total Patients Enrolled
Benjamin TollPrincipal InvestigatorMedical University of South Carolina
1 Previous Clinical Trials
282 Total Patients Enrolled
Lisa Fucito, Ph.D.Principal InvestigatorYale University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently using medication to help me stop smoking.I am unable to give my own consent for medical procedures.I am not fluent in English.I cannot use varenicline due to severe kidney problems.I am a woman under 55 and have not confirmed I'm not pregnant.I want to quit e-cigarettes and am willing to set a quit date.You have used an e-cigarette with nicotine for at least 25 days in the last month.You have used an e-cigarette with nicotine for more than 6 months.I want to quit e-cigarettes and am willing to set a quit date.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo + Self-Change Pamphlet
- Group 2: Varenicline + Self-Change Pamphlet
Awards:
This trial has 0 awards, including: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.
Smoking Cessation Patient Testimony for trial: Trial Name: NCT05541497 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this trial currently enrolling participants?
"Clinicaltrials.gov indicates that, while the trial originally posted on November 1st 2022 is no longer accepting candidates, there are 142 other studies actively soliciting enrolment at this time."
Answered by AI
Has the FDA authorized Varenicline Tartrate for general use?
"Varenicline Tartrate was rated 2 on a safety scale; since this is Phase 2, there are preliminary studies proving its security but no proof of efficacy."
Answered by AI
Who else is applying?
What state do they live in?
Texas
California
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
1
3+
Why did patients apply to this trial?
My grandkids really want me to stop smoking and I really need to stop. I've tried many methods to try to stop smoking. So far none have worked. I want my life back.
PatientReceived no prior treatments
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