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Nicotine Replacement Therapy

Nicotine Pouches for Smoking Cessation (Pack2Pouch Trial)

N/A
Waitlist Available
Led By Amanda Palmer, PhD.
Research Sponsored by Medical University of South Carolina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 21+
Current cigarette smoking (25+ days per previous month, 5 or more cigarettes/day, for greater than 1 year, greater than 100 lifetime cigarettes)
Must not have
Medical conditions contraindicated to NRT use (including pregnancy, breastfeeding, and nursing, past month myocardial infarction, current untreated cardiac arrhythmia, current severe angina, current uncontrolled severe vascular disease)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 28 and day 56
Awards & highlights
No Placebo-Only Group

Summary

This trial is looking at how well nicotine pouches, like Zyn, help people quit smoking cigarettes. Participants will be given nicotine pouches to use instead of cigarettes for 28 days and will provide

Who is the study for?
This trial is for individuals who are currently cigarette smokers and want to switch to a less harmful alternative. Participants will be asked to use tobacco-free nicotine pouches with varying nicotine levels over 4 weeks, provide breath and cheek swab samples, and answer questions about their tobacco use.
What is being tested?
The study is testing the effectiveness of low versus high nicotine dose in tobacco-free oral nicotine pouches at helping cigarette smokers switch away from smoking. It involves an initial visit, a month-long period using the provided pouches, followed by a final visit and additional follow-up.
What are the potential side effects?
While specific side effects are not listed here, it's important to note that nicotine can cause addiction and may lead to withdrawal symptoms when trying to quit or reduce usage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 21 years old or older.
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I have been a regular smoker, smoking 5 or more cigarettes daily for over a year.
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I have used TNF blockers less than 5 times in my life.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have any health conditions that prevent me from using nicotine replacement therapy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 28 and day 56
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 28 and day 56 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Smoking Reduction
Switching
Secondary study objectives
Tobacco-Free Oral Nicotine Pouches (TFNP) Use

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Low NicotineExperimental Treatment1 Intervention
Low dosage nicotine pouches (3mg)
Group II: High NicotineExperimental Treatment1 Intervention
High dosage nicotine pouches (6mg)

Find a Location

Who is running the clinical trial?

Medical University of South CarolinaLead Sponsor
977 Previous Clinical Trials
7,400,937 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,594 Previous Clinical Trials
3,328,686 Total Patients Enrolled
Amanda Palmer, PhD.Principal InvestigatorMedical University of South Carolina
~33 spots leftby Dec 2025
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