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Nicotine Replacement Therapy
Nicotine Pouches + Lozenges for Smoking Cessation
Phase 4
Waitlist Available
Led By Megan Piper, PhD
Research Sponsored by University of Wisconsin, Madison
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
≥ 21 years old (i.e., able to legally purchase tobacco products)
No nicotine pouch or smokeless tobacco (including snus) use within the last 6 months
Must not have
Currently taking bupropion for non-smoking cessation reasons (e.g., Wellbutrin for depression)
Currently in treatment for psychosis or bipolar disorder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 3 weeks
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group
Summary
This trial aims to see if nicotine pouches and mini lozenges can help people quit smoking. Participants will use these products or nothing for a week, then try not to smoke for 3
Who is the study for?
This trial is for individuals who are currently smoking and interested in quitting. Participants will try nicotine pouches or mini lozenges as alternatives to cigarettes. They must be willing to attend several research visits, complete questionnaires, and use a smartphone app to track their usage of products.
What is being tested?
The study is testing the effectiveness of nicotine pouches and mini lozenges in helping smokers quit by substituting these products for cigarettes. Over a four-week period, participants will first use one of the products for a week followed by an attempt to abstain from smoking for three weeks.
What are the potential side effects?
Potential side effects may include irritation in the mouth or throat from using nicotine pouches or lozenges, possible nausea, headaches, heart palpitations due to nicotine intake, and cravings or withdrawal symptoms associated with reducing cigarette use.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 21 years old or older.
Select...
I haven't used nicotine pouches or smokeless tobacco in the last 6 months.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently taking bupropion for reasons other than to quit smoking.
Select...
I am currently being treated for psychosis or bipolar disorder.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 3 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 3 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Mean number of cigarettes smoked per day during the 21-day switching period.
Secondary study objectives
Change in cigarette craving
Use of study product
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Nicotine Mini LozengesExperimental Treatment1 Intervention
Participants will use mini lozenges with dosing based on time to first cigarette (2mg - 4mg)
Group II: 6mg Nicotine PouchesExperimental Treatment1 Intervention
Participants will use 6mg nicotine pouches
Group III: 3mg Nicotine PouchesExperimental Treatment1 Intervention
Participants will use 3mg nicotine pouches
Group IV: No Study ProductActive Control1 Intervention
Participants randomized to this arm will not receive any intervention
Find a Location
Who is running the clinical trial?
University of Wisconsin, MadisonLead Sponsor
1,234 Previous Clinical Trials
3,199,991 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,826 Previous Clinical Trials
8,166,256 Total Patients Enrolled
Megan Piper, PhDPrincipal InvestigatorUniversity of Wisconsin, Madison
2 Previous Clinical Trials
1,068 Total Patients Enrolled