Your session is about to expire
← Back to Search
Nicotine Replacement Therapy
E-cigarette Flavors + Nicotine for Nicotine Use
Phase 2
Waitlist Available
Led By Elise DeVito, PhD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Aged 18 to 30
Past month daily nicotine-containing e-cigarette, cigarette, and/or cigar/little cigar/cigarillo use
Timeline
Screening 3 weeks
Treatment Varies
Follow Up immediately after intervention
Awards & highlights
Study Summary
This trial will test whether different flavors of e-cigarettes have different impacts on how much people use them, depending on the nicotine level.
Who is the study for?
This trial is for English-speaking individuals aged 18-30 from Connecticut who regularly use nicotine products and can commit to the study's requirements, including overnight nicotine abstinence. They must have normal cardiovascular measures and not be seeking treatment for nicotine dependence or planning to quit soon. Pregnant or breastfeeding women, those with allergies to e-cigarette ingredients, respiratory illnesses, multiple chemical sensitivities, or unvaccinated for COVID-19 cannot participate.Check my eligibility
What is being tested?
The study examines how different flavors ('Green Apple', 'Menthol', 'Watermelon', 'Menthol/Mint') and various nicotine strengths (0 mg/mL, 6 mg/mL, 12 mg/mL, 24 mg/mL) in e-cigarettes affect usage patterns. It aims to determine if menthol and fruit flavors influence e-cigarette use differently across these nicotine doses.See study design
What are the potential side effects?
Potential side effects may include reactions related to the inhalation of flavored e-liquids such as throat irritation or allergic responses specific to the individual's sensitivity towards propylene glycol, vegetable glycerin or flavorings like menthol and fruit variants.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 30 years old.
Select...
I have used nicotine products like e-cigarettes or cigars daily in the past month.
Select...
My heart rate, blood pressure, and oxygen levels are within normal ranges.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ immediately after intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediately after intervention
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
E-cigarette use
Subjective drug ratings
Trial Design
4Treatment groups
Experimental Treatment
Group I: E-liquid Order 'D'Experimental Treatment9 Interventions
One nicotine level condition is a high nicotine e-liquid (24 mg/mL nicotine). All participants will be given all e-liquids (i.e., all 20 nicotine*flavor combinations (4 nicotine* 5 flavor combinations)) in this within-subject, cross-over design study. Participants will be randomized the order in which they self-administer the 20 nicotine*flavor combinations of e-liquid (across and within the 4 visits). The specific order cannot be described here without disrupting the double-blind nature of the study design.
Group II: E-liquid Order 'C'Experimental Treatment9 Interventions
One nicotine level condition is a medium nicotine e-liquid (12 mg/mL nicotine). All participants will be given all e-liquids (i.e., all 20 nicotine*flavor combinations (4 nicotine* 5 flavor combinations)) in this within-subject, cross-over design study. Participants will be randomized the order in which they self-administer the 20 nicotine*flavor combinations of e-liquid (across and within the 4 visits). The specific order cannot be described here without disrupting the double-blind nature of the study design.
Group III: E-liquid Order 'B'Experimental Treatment9 Interventions
Order 'B' for E-liquid Self-Administration: All participants will be given all e-liquids (i.e., all 20 nicotine*flavor combinations (4 nicotine* 5 flavor combinations)) in this within-subject, cross-over design study. Participants will be randomized the order in which they self-administer the 20 nicotine*flavor combinations of e-liquid (across and within the 4 visits). The specific order cannot be described here without disrupting the double-blind nature of the study design.
Group IV: E-liquid Order 'A'Experimental Treatment9 Interventions
Order 'A' for E-liquid Self-Administration: All participants will be given all e-liquids (i.e., all 20 nicotine*flavor combinations (4 nicotine* 5 flavor combinations)) in this within-subject, cross-over design study. Participants will be randomized the order in which they self-administer the 20 nicotine*flavor combinations of e-liquid (across and within the 4 visits). The specific order cannot be described here without disrupting the double-blind nature of the study design.
Find a Location
Who is running the clinical trial?
National Institute on Drug Abuse (NIDA)NIH
2,467 Previous Clinical Trials
2,619,063 Total Patients Enrolled
3 Trials studying Nicotine
77 Patients Enrolled for Nicotine
Yale UniversityLead Sponsor
1,848 Previous Clinical Trials
2,737,758 Total Patients Enrolled
1 Trials studying Nicotine
18 Patients Enrolled for Nicotine
Elise DeVito, PhDPrincipal InvestigatorYale University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with a psychiatric disorder.I don't have any respiratory illnesses or other conditions that would stop me from joining the study.I am between 18 and 30 years old.I am not pregnant or breastfeeding.I have used nicotine products like e-cigarettes or cigars daily in the past month.My heart rate, blood pressure, and oxygen levels are within normal ranges.I am willing to follow the study's rules, use e-liquids as directed, attend sessions, follow COVID guidelines, and avoid nicotine overnight.I am currently seeking or undergoing treatment to quit smoking or vaping.I am allergic to propylene glycol, vegetable glycerin, menthol, mint, green apple or watermelon flavors, or have had reactions to e-cigarettes.You have a history of severe allergies or sensitivities that cause breathing problems and require the use of an EpiPen.You have not used e-cigarettes at least 10 times in the last 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: E-liquid Order 'A'
- Group 2: E-liquid Order 'B'
- Group 3: E-liquid Order 'D'
- Group 4: E-liquid Order 'C'
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.
What is the maximum number of participants currently permitted to join this clinical trial?
"Affirmative. According to the info on clinicaltrials.gov, this trial is actively seeking participants and has been posted since October 27th 2022 without any edits made to it since then. The study requires 60 individuals from one medical centre for recruitment purposes."
Answered by AI
Does this trial accept participants who are of advanced age?
"This trial only permits those aged between 18 - 30 to join its ranks. Conversely, there are 4 studies catering for minors and 56 investigations suited towards individuals above 65 years of age."
Answered by AI
Are any additional participants being sought for this research endeavor?
"According to clinicaltrials.gov, this trial is actively recruiting participants. The original announcement was published on the 27th of October 2022 and has been updated since then as well."
Answered by AI
Has 'Menthol' flavor obtained FDA approval?
"Because this trial is only in Phase 2, there exists some evidence that 'Menthol' flavor is safe; however, the efficacy of it has not yet been determined. Consequently, our team at Power assigned a rating of two to the safety of this particular flavour."
Answered by AI
What prerequisites must be met to become eligible for this clinical trial?
"To be considered for the trial, nicotine users aged 18 to 30 must meet eligibility criteria. It is anticipated that 60 individuals will take part in this study."
Answered by AI
Have any other clinical trials been conducted to evaluate the efficacy of 'Menthol' flavor?
"Currently, there are 71 ongoing clinical trials related to 'Menthol' flavour with 5 of them already in Phase 3. Green Bay, Wisconsin is a key location for these experiments but other places around the world have 204 sites running studies regarding this topic."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger