Study Summary
This trial will help to understand if menthol flavored e-cigarettes can help people quit smoking menthol cigarettes, in the context of a ban on menthol cigarettes.
Treatment Effectiveness
Phase-Based Effectiveness
N/A
Study Objectives
1 Primary · 4 Secondary · Reporting Duration: Week 12
Week 8
Average number of cigarettes smoked per day in the past week to evaluate changes in smoking behavior
Changes in nicotine dependence using the Nicotine Dependence for Daily Smokers Scale
Percent days of e-cigarette use
Percent days smoke-free
Week 8
Change in Quitting motivation and confidence
Week 12
Number of quit attempts during follow-up
Week 8
Quit intentions using the Stages of Change Assessment
Trial Safety
Phase-Based Safety
Awards & Highlights
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Trial Design
3 Treatment Groups
no menthol ban
1 of 3
menthol ban in cigarettes only
1 of 3
menthol ban in both cigarettes and e-cigarettes
1 of 3
Active Control
Experimental Treatment
150 Total Participants · 3 Treatment Groups
Primary Treatment: total menthol ban · No Placebo Group · N/A
menthol ban in cigarettes only
Behavioral
Experimental Group · 1 Intervention: menthol ban in cigarettes only · Intervention Types: Behavioralmenthol ban in both cigarettes and e-cigarettes
Behavioral
Experimental Group · 1 Intervention: total menthol ban · Intervention Types: Behavioralno menthol banNoIntervention Group · 1 Intervention: no menthol ban · Intervention Types:
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: week 12
Who is running the clinical trial?
Yale UniversityLead Sponsor
1,727 Previous Clinical Trials
20,519,438 Total Patients Enrolled
Krysten Bold, PhDPrincipal InvestigatorYale University
Eligibility Criteria
Age 18+ · All Participants · 3 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You are generally healthy.
You are currently smoking cigarettes.
You have used e-cigarettes before and are willing to use them again.
Who else is applying?
What state do they live in?
| Connecticut | 100.0% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| Yale University | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
Frequently Asked Questions
Is recruitment for this experiment still ongoing?
"Clinicaltrials.gov confirms that, as of October 18th 2022, this trial is not actively seeking patients at the moment. That being said, there are 42 other clinical trials currently enrolling volunteers for their studies." - Anonymous Online Contributor
Unverified Answer