Health TrialsbyHealthPanel

Evaluation of Low and High Nicotine Tobacco Free Nicotine Pouches

ConditionsCigarette SmokingNicotine DependenceSmoking Cessation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorMedical University of South Carolina

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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)

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • High Nicotine Dose

    Behavioral

    Will receive a 5-week supply of 6 mg Zyn pouches. Those who smoke 5-20 cigarettes per day will receive 1 tin per day = 35 tins, whereas those who smoke more will receive 2 tins/day \[70 tins\])

  • Low Nicotine Dose

    Behavioral

    Will receive a 5-week supply of 3 mg Zyn pouches. Those who smoke 5-20 cigarettes per day will receive 1 tin per day = 35 tins, whereas those who smoke more will receive 2 tins/day \[70 tins\])

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: High NicotineExperimental treatment 1 intervention
Group B: Low NicotineExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Switching

Switching will be defined at 7-day point-prevalence biochemically-confirmed abstinence from cigarettes alongside self-reported use of nicotine pouches. Non-responders and missing data will be coded as smoking.

Time frame
Day 28 and Day 56
2

Smoking Reduction

Baseline and daily survey data will be used to calculate the change of smoking (average cigarettes per day) between groups from baseline to end of sampling.

Time frame
Day 28 and Day 56

Secondary outcomes

1

Tobacco-Free Oral Nicotine Pouches (TFNP) Use

Daily surveys will capture number of days of TFNP use, regardless of smoking.

Time frame
Day 28

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medical University of South Carolina

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator

Source ClinicalTrials.gov
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