Status:
RECRUITING
Use of Nicotine Pouches Among Daily Smokers
Lead Sponsor:
Milton S. Hershey Medical Center
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Tobacco Dependence
Eligibility:
All Genders
21-70 years
Phase:
NA
Brief Summary
The purpose of this clinical trial is to understand the health effects of a new oral nicotine pouch, and also to understand if this product can help reduce traditional cigarette smoking. The main aims...
Detailed Description
Nicotine Pouches represent a rapidly growing category in the U.S. tobacco market, but little is known about their health effects (including addiction) or effects on cigarette smoking. The investigator...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 17 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2028
Estimated Enrollment :
375 Patients enrolled
Trial Details
Trial ID
NCT06043362
Start Date
September 17 2024
End Date
August 1 2028
Last Update
October 1 2025
Active Locations (2)
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1
Penn State College of Medicine
Hershey, Pennsylvania, United States, 17033
2
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030