Use of Nicotine Pouches Among Daily Smokers

Launched by MILTON S. HERSHEY MEDICAL CENTER · Sep 12, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the use of a new oral nicotine pouch designed to help daily smokers reduce their cigarette consumption. The researchers want to see how using these pouches affects the harmful substances in the body and if they help people cut down on smoking traditional cigarettes. Participants will be assigned to one of six groups based on different strengths and flavors of nicotine pouches and will use them for 16 weeks, aiming to reduce their cigarette use by at least 75%.

To join the study, you need to be a regular smoker, using at least five cigarettes a day for the past year, and be willing to try to cut down on smoking. You should be comfortable reading and writing in English and have access to email and the internet. During the study, you’ll answer questionnaires and provide some health samples. This trial is open to adults aged 18 to 65, and it's important to note that some health conditions and recent substance use may prevent you from participating. If you're interested in reducing your smoking and trying a new approach, this could be a chance to contribute to important research!

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Commonly smoke ≥ 5 cigarettes per day (at least 2 days/week) for at least the prior 12 months
• • Exhaled CO measurement of ≥ 6 parts per million at baseline
• • Must be interested in reducing cigarette consumption by at least 50% and willing to try nicotine pouches
• • Able to understand, read and write in English
• • Access to e-mail and a smartphone/computer that has reliable internet connection
• • Able to understand and give informed consent
• Exclusion Criteria:
• • Plans to quit smoking within the next 30 days
• • Currently pregnant, breastfeeding, or planning to become pregnant in the next 6 months
• • Recent (past 3 months) unstable illness that may increase risks of participation or ability to participate fully (e.g. hospitalization for a mental health condition or substance use disorder in prior 6 months, stroke or myocardial infarction in the past year)
• • Serious current respiratory diseases (e.g. exacerbations of asthma or chronic obstructive pulmonary disease \[COPD\], requiring oxygen or oral prednisone), kidney disease (e.g. requiring dialysis), liver disease (e.g cirrhosis), or any medical disorder/medication that may affect participant safety or biomarker data
• • Use of a nicotine pouch or other non-cigarette nicotine product (e-cigarette, pipe, cigar, chew, snus, hookah, IQOS) for 5 or more days in the past 28 days
• • Use of illegal drugs daily or weekly in the past 3 months
• • Use of combustible (smoked) recreational or medical marijuana weekly in the past 3 months (less frequent smoked medical marijuana or use of other forms of medical marijuana are ok)
• • Other member of the household currently participating in the study
• • Any other condition that in the opinion of the investigator would make it unlikely that the participant could comply with the study protocol