Flavored Nicotine Pouches for Smoking Reduction
What You Need to Know Before You Apply
What is the purpose of this trial?
The goal of this clinical trial is to learn about the role of flavored on!® nicotine pouch products (the research products), an oral tobacco-leaf-free product, in the replacement of cigarettes with the use of the research products among adults who smoke cigarettes. The main question it aims to answer is whether flavored (vs. non-flavored) research products generate greater reduction of cigarette smoking among adults who smoke cigarettes.Participants will be provided with research products to use for 6 weeks. Researchers will compare the reduction in cigarette smoking between participants with access to a complete flavor profile of research products and participants with access to only the Original (non-flavored) variety of research product to see if reduction in cigarette smoking is greater among those with access to flavored research products.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it does exclude those taking psychoactive medications like antipsychotics or mood stabilizers.
Is it safe to use flavored nicotine pouches for smoking reduction?
How do flavored on!® nicotine pouches differ from other smoking reduction treatments?
Flavored on!® nicotine pouches are unique because they are tobacco-free, oral products that come in various flavors and nicotine strengths, offering a potentially lower-risk alternative to traditional cigarettes and tobacco-based products. Unlike other smoking reduction treatments, these pouches do not contain tobacco leaves and are designed to reduce harm for smokers who cannot or do not want to quit smoking entirely.13567
What data supports the effectiveness of the treatment Flavored on!® Nicotine Pouch Products for smoking reduction?
Who Is on the Research Team?
Hui Cheng, PhD
Principal Investigator
ALCS
Are You a Good Fit for This Trial?
Adults aged 22-65 who smoke at least 5 cigarettes daily for the past year, want to switch to a smoke-free tobacco product, and can use a smartphone with text and data. Excluded are those in poor health or with certain medical conditions, involved in tobacco litigation or industry, pregnant/nursing women not using birth control, heavy marijuana users, and recent participants in other tobacco studies.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline
Participants are followed for 3-7 days to establish baseline measures of cigarettes smoked per day, with at least two CO readings collected
Treatment
Participants use research products for 6 weeks, with different access to flavors based on group assignment
Follow-up
Participants are monitored for safety and effectiveness after treatment, including a 6-month follow-up survey
What Are the Treatments Tested in This Trial?
Interventions
- Flavored on!® Nicotine Pouch Products
Flavored on!® Nicotine Pouch Products is already approved in United States, Canada, United Kingdom for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Altria Client Services LLC
Lead Sponsor
Rose Research Center, LLC
Industry Sponsor