1280 Participants NeededMy employer runs this trial

ENDS Flavors for Smoking

Recruiting at 6 trial locations
ME
Overseen ByMontgomery E. Hedgecock
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The overall purpose of this study will be to assess primary combustible cigarette users' abstinence from smoking their usual brand of combustible cigarettes at the end of the study, when provided with an electronic nicotine delivery system (ENDS) power unit (2) and varying levels of access to tobacco-flavored, menthol-flavored, mint, or non-tobacco/non-menthol/non-mint-flavored cartridge-based e-liquids (collectively referred to as the investigational product) within their assigned study arm over a three-month (ninety-day) period.

Who Is on the Research Team?

MT

Melissa Tapia, Ph.D.

Principal Investigator

RAIS Company

Are You a Good Fit for This Trial?

This trial is for adults aged 21-65 who are generally healthy, currently smoke at least 5 cigarettes on most days, have smoked at least 100 cigarettes in their life, are willing to try e-cigarettes (ENDS), and can use a smartphone. Pregnant individuals or those planning pregnancy cannot join.

Inclusion Criteria

* Able to read, understand, and are willing to sign an Informed Consent Form (ICF) and complete questionnaires written in English.
* Currently smoke at least 5 CC on smoking days in the past 30 days.
* Smoke CC on 15 or more of the past 30 days.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Approximately 8 weeks
1 visit (in-person)

Trial Period

Participants sample available flavors within their Study Arm for one week

1 week
1 visit (in-person)

Treatment

Participants use ENDS and complete surveys; flavor changes allowed at specified visits

13 weeks
4 visits (in-person) on Days 0, 30, 60, and 90; optional visits on Days 7, 14, and 21

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Trial Overview

The study tests if giving smokers different flavors of e-cigarette cartridges (tobacco, menthol, mint, or other) affects whether they quit regular cigarette smoking over three months. Participants are randomly assigned to groups with varying flavor access.

How Is the Trial Designed?

3

Treatment groups

Active Control

Group I: Tobacco and two flavors of non-tobacco/non-menthol/mintActive Control3 Interventions
Group II: Tobacco, Mint, and Menthol FlavorActive Control3 Interventions
Group III: Tobacco FlavorActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

RAI Services Company

Lead Sponsor

Trials
43
Recruited
7,700+