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New treatment option for Tobacco Dependence
Official title Use of Nicotine Pouches Among Daily Smokers
ClinicalTrials.gov ID: NCT06043362
What this study is testing
- What it's testing
- 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 are: 1.
- Time commitment: about 16 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 70. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- 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...
- Serious current respiratory diseases (e.g. exacerbations of asthma or chronic obstructive pulmonary disease [COPD], requiring oxygen or oral...
- 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...
- Use of illegal drugs daily or weekly in the past 3 months
See the full eligibility 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
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Hershey, Pennsylvania, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 16 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years to 70 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hershey, Pennsylvania, United States; Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.