Electronic Nicotine Delivery System for Smoking

Recruiting at 25 trial locations

Overseen By Montgomery Hedgecock

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: RAI Services Company

Must not be taking: Antidepressants

Disqualifiers: Heart disease, Diabetes, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 12 weeks

1950 Participants Needed

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, or non-tobacco/non-menthol-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?

Melissa Tapia, Ph.D.

Principal Investigator

RAIS Service Co

Are You a Good Fit for This Trial?

This trial is for primary smokers who regularly use combustible cigarettes and are interested in trying to quit by using an electronic nicotine delivery system (ENDS) over a three-month period. Specific eligibility criteria details were not provided.

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 10 cigarettes on smoking days in the past 30 days

Smoke cigarettes regularly for at least 12 months

Exclusion Criteria

Persons with pacemakers or other embedded electronic medical devices fitted

Persons who self-report they are allergic/sensitive to cosmetics or fragrances or to any ingredient listed in Vuse commercial products or similar products, including Carvone (L-) and Benzyl alcohol

Participants who have used ENDS, nicotine pouch or smokeless tobacco products on 5 or more days in the past 30 days

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Enrollment and Trial Period

Participants are enrolled, randomized, and begin a one-week trial period to sample available flavors

1 week

1 visit (in-person)

Treatment

Participants use the electronic nicotine delivery system with varying flavor access over a three-month period

12 weeks

4 mandatory visits (in-person) on Day 0, Day 30, Day 60, and Day 90; optional visits on Day 7, Day 14, and Day 21

Follow-up

Participants are monitored for abstinence and product use, with data collected via surveys and puffing topography

3 months

What Are the Treatments Tested in This Trial?

Interventions

• P2611222
• P2613422
• P2615022
• P2615122

Trial Overview The study is testing whether different flavors of e-liquids (tobacco, menthol, or non-tobacco/non-menthol) used with ENDS affect the ability of cigarette smokers to abstain from smoking their usual brand over ninety days.

How Is the Trial Designed?

Group I: Tobacco, Menthol, Non Tobacco Non Menthol Flavors Active Control 4 Interventions

Participants can choose between tobacco, menthol, and non-tobacco non-menthol flavor variants at one nicotine level (5%).

Group II: Tobacco Flavor Active Control 1 Intervention

Participants can use a tobacco flavor variant at one nicotine level (5%).

Group III: Tobacco and Menthol Flavor Active Control 2 Interventions

Participants can choose between tobacco and menthol flavor variants at one nicotine level (5%).

Who Is Running the Clinical Trial?

RAI Services Company

Lead Sponsor

Trials

43

Recruited

7,700+