Clinical trial NCT06678789: Evaluation of Low and High Nicotine Tobacco Free Nicotine Pouches
Official title: Evaluation of Low and High Nicotine Tobacco Free Nicotine Pouches As a Harm Reducing Substitute for Combustible Cigarettes - (Pack2Pouch)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cigarette Smoking
Nicotine Dependence
Smoking Cessation
Keywords: Smoking
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2024-11-07
Enrollment: 50
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Tobacco-free oral nicotine pouches (such as Zyn brand) are a less harmful alternative to cigarette smoking. Pouches, however, contain nicotine, and addictive substance that is not risk-free. The present study is evaluating how well nicotine pouches, at different nicotine levels, help people switch away from smoking cigarettes. People who smoke cigarettes will be asked to answer questions about their tobacco product use and provide breath samples and cheek swab samples at an in-person visit to MUSC Charleston. Participants will then be provided with a 28-day supply of nicotine pouches, and will be asked to switch from smoking to pouches over the course of 4 weeks. Finally, participants will complete a final visit at MUSC, and will answer more questions about their tobacco use 1-month later.

Detailed description: The proposed research project evaluates the potential for tobacco-free oral nicotine pouches (TFNPs) to serve as harm reduction tools at two nicotine concentrations, inclusive of behavioral and biomarker outcomes, using a clinical trial design. Specifically, in a randomized pilot study, participants who smoke will be recruited and sent TFNPs to sample for 4 weeks in either high (6 mg) or low (3 mg) nicotine content strengths. Participants will report tobacco use behaviors and submit biological samples throughout the study. This design allows for evaluation of the effect of nicotine content within alternative, harm-reducing tobacco products on key outcomes including: 1) complete switching from cigarette smoking to non-cigarette product use; 2) cigarette smoking reduction; 3) changes in biomarkers of harm (DNA damage, respiratory symptoms), 4) nicotine dependence, and 5) subjective effects of product use.

Eligibility criteria: Inclusion Criteria:

* Age 21+
* current cigarette smoking (25+ days per previous month, 5 or more cigarettes/day, for greater than 1yr, greater than 100 lifetime cigarettes)
* have not used TNFPs more than 5 times during their lifetime
* willing and able to attend 2 in-person visits in Charleston (to assess biomarkers)
* have internet access

Exclusion Criteria:

* Lack of proficiency in English.
* Use of other combustible tobacco products (i.e., cigars, cigarillos, hookahs) and/or other non-combusted nicotine/tobacco products (i.e., e-cigarettes, smokeless tobacco) in the past 30 days.
* Current use of smoking cessation medications (i.e., varenicline, bupropion, nicotine replacement therapy).
* Use of marijuana within the past month, and unwillingness to abstain from marijuana during course of study.
* 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).

Primary outcomes:
measure: Switching
timeFrame: Day 28 and Day 56
measure: Smoking Reduction
timeFrame: Day 28 and Day 56
Secondary outcomes:
measure: Tobacco-Free Oral Nicotine Pouches (TFNP) Use
timeFrame: Day 28
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Amanda Palmer, PhD.
role: PRINCIPAL_INVESTIGATOR
References: