← Back to Search

Behavioral Intervention

E-cigarettes and Nicotine Pouches for Cigarette Smokers

N/A

Recruiting

Research Sponsored by Abramson Cancer Center at Penn Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male and female smokers who are > 21 years of age and self-report smoking at least 5 cigarettes (menthol and/or non-menthol) per day for at least the last 6 months.

5 or more failed quit attempts and the use of smoking cessation medication on at least one prior attempt.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 49 days (days 1-49)

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare e-cigarettes and oral nicotine pouches to see which one is better at helping cigarette smokers to quit smoking. 200 cigarette smokers will participate, and they will be randomly assigned to either

Who is the study for?

This trial is for persistent cigarette smokers over 21 years old who smoke at least 5 cigarettes daily for the past 6 months, have tried to quit smoking at least five times, and are not using other nicotine forms. Participants must have a breath carbon monoxide level above 10 ppm, plan to stay in the area for six weeks, and be able to give informed consent.

What is being tested?

The study compares e-cigarettes (ECIGS) with oral nicotine pouches (ONPS) as alternatives to regular cigarettes among 200 smokers. It's designed to see which substitute reduces harmful biomarkers more effectively over a six-week period while also assessing their satisfaction and preference compared to traditional cigarettes.

What are the potential side effects?

Potential side effects from using ECIGS may include throat irritation or coughing, while ONPS might cause mouth or gum discomfort. Both methods deliver nicotine, which can lead to dependence or withdrawal symptoms if stopped abruptly.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am over 21 and have smoked 5 or more cigarettes daily for the last 6 months.

Select...

I have tried to quit smoking more than 5 times and used medication at least once.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 49 days (days 1-49)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~49 days (days 1-49)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 49 days (days 1-49) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Cigarette Consumption

Cigarette Smoking Across Follow-Up

Secondary study objectives

Biomarkers of Exposure: 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL)

Biomarkers of Exposure: Carbon Monoxide (CO)

Biomarkers of Exposure: Mean mid-expiratory forced expiratory flow (FEF25% - 75%)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: ONPSExperimental Treatment1 Intervention

Participants randomized to ONPS will be provided with oral nicotine pouches and be instructed to switch from smoking combustible cigarettes to using only the study-provided nicotine pouches. Participants will be able to choose between Original, Mint, Berry, and Citrus flavored nicotine pouches. They will receive their supply of nicotine pouches in 7-day increments, based on baseline smoking behavior.

Group II: ECIGSExperimental Treatment1 Intervention

Participants randomized to ECIGS will be provided with an e-cigarette device and be instructed to switch from smoking combustible cigarettes to using only the study-provided e-cigarette device. Participants will be able to choose between Tobacco, Menthol, Watermelon, and Blueberry flavored nicotine pods. They will receive their supply of nicotine pods in 7-day increments, based on baseline smoking behavior.

0 / 2Eligibility criteria met