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E-Cigarette Flavors for Nicotine Addiction

Phase 1
Waitlist Available
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (+10 minutes) to end of lab session (+40 minutes)
Awards & highlights

Study Summary

This trial looks at the effects of flavors when added to nicotine in e-cigarettes, in both young and old adult smokers.

Eligible Conditions
  • Nicotine Addiction

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (+10 minutes) to end of lab session (+40 minutes)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (+10 minutes) to end of lab session (+40 minutes) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change score in liking/wanting of e-cigarette

Trial Design

6Treatment groups
Experimental Treatment
Group I: Low nicotine, tobaccoExperimental Treatment2 Interventions
6 mg nicotine combined with tobacco flavored e-juice
Group II: Low nicotine, strawberryExperimental Treatment2 Interventions
6 mg nicotine combined with strawberry flavored e-juice
Group III: Low nicotine, mentholExperimental Treatment2 Interventions
6 mg nicotine combined with menthol flavored e-juice
Group IV: Hign Nicotine, strawberryExperimental Treatment2 Interventions
18 mg nicotine combined with strawberry flavored e-juice
Group V: High nicotine, tobaccoExperimental Treatment2 Interventions
18 mg nicotine combined with tobacco flavored e-juice
Group VI: High nicotine, mentholExperimental Treatment2 Interventions
18 mg nicotine combined with menthol flavored e-juice
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nicotine
2005
Completed Phase 4
~2980
Flavor
2019
Completed Phase 1
~220

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,847 Previous Clinical Trials
2,736,398 Total Patients Enrolled
4 Trials studying Nicotine Addiction
194 Patients Enrolled for Nicotine Addiction
National Institute on Drug Abuse (NIDA)NIH
2,464 Previous Clinical Trials
2,618,463 Total Patients Enrolled
15 Trials studying Nicotine Addiction
2,130 Patients Enrolled for Nicotine Addiction

Media Library

Flavor (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03635333 — Phase 1
Nicotine Addiction Research Study Groups: Low nicotine, tobacco, Low nicotine, menthol, Low nicotine, strawberry, High nicotine, tobacco, High nicotine, menthol, Hign Nicotine, strawberry
Nicotine Addiction Clinical Trial 2023: Flavor Highlights & Side Effects. Trial Name: NCT03635333 — Phase 1
Flavor (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03635333 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants is this investigation enlisting?

"Affirmative. The clinical trial, which was first launched on March 15th 2019, is actively recruiting participants according to information found on clinicaltrials.gov. There are 120 spots available at a single location for this study."

Answered by AI

Is enrollment available for this experiment currently?

"Per information on clinicaltrials.gov, this medical experiment is accepting participants. It was initially declared open for recruitment in March of 2019 and the details were most recently updated in June 2022."

Answered by AI

Does the FDA recognize Flavor as a viable medication?

"Our team at Power assigned a rating of 1 to Flavor's safety due to the lack of research supporting its efficacy and limited data confirming it is safe."

Answered by AI

Is there an age restriction for volunteers participating in the trial?

"As per the prerequisites of this trial, individuals between 18 and 50 years old are eligible for enrollment."

Answered by AI

What other research endeavors have utilized Flavor as a focus?

"Presently, 71 studies are underway examining the efficacy and safety of Flavor. 5 of those research projects have reached Phase 3 while 204 sites across Green Bay Wisconsin offer this trial to patients hoping for a viable treatment option."

Answered by AI

Who is eligible to join in this research experiment?

"This clinical trial is searching for 120 participants who are 18 to 50 years old and have nicotine use disorder."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Effects of E-Cigarette Flavors on Adults TCORS 2.0
2019. "Effects of E-Cigarette Flavors on Adults TCORS 2.0". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03635333.
~21 spots leftby Apr 2025
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