Health TrialsbyHealthPanel

Oral Nicotine Pouches Versus Nicotine Replacement Therapy to Reduce Cigarette Use for Smokers in Rural Appalachia

ConditionCigarette Smoking-Related Carcinoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorOhio State University Comprehensive Cancer Center

About this trial

This clinical trial compares the use of oral nicotine pouches to nicotine replacement therapy, consisting of nicotine patches and lozenges, to reduce cigarette use in smokers living in rural Appalachia. The lung and oral cancers that plague Appalachia are fueled by cigarette smoking. Oral nicotine pouches which contain nicotine but no tobacco leaf, present a new opportunity to reduce cancer risk among Appalachian adults who smoke. Oral nicotine pouches and nicotine replacement therapy may work well to reduce cigarette use for smokers in rural Appalachia.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Read and speak English

21 years or older

Smoke ≥ 5 cigarettes per day for the past year

Willing to use Oral Nicotine Pouches (ONP) or Nicotine Replacement Therapy (NRT)

Disqualifiers

Report currently using smoking cessation medications, NRT, or actively seeking treatment for smoking cessation

Use of ONPs in past 3 months

Use of Nicotine Replacement Therapies in past 3 months

Use of other tobacco products > 10 days/month

Trial design

Design model

Parallel

Treatments tested in this trial

  • Carbon Monoxide Measurement

    Other intervention

    Undergo carbon monoxide measurement

  • Nicotine Lozenge

    Other intervention

    Use nicotine lozenge

  • Oral Nicotine Pouch

    Other intervention

    Use oral nicotine pouch

  • Nicotine Patch

    Other intervention

    Use nicotine patch

  • Survey Administration

    Other intervention

    measurements; data gathering

  • Check-in Phone Calls

    Other intervention

    Check-in phone calls to study participants

Treatment groups

1,000 Participants
are divided into 2 treatment groups
Group A: Arm I (oral nicotine pouch)Experimental treatment 4 interventions
Group B: Arm II (nicotine replacement therapy)Active comparator 5 interventions

Trial outcomes

Primary outcomes

1

Biochemically verified 7-day point prevalence abstinence from cigarettes

Statistical analyses will be performed using SAS 9.4. P-values less than 0.05 will be considered statistically significant. Will be presented as frequencies and proportions and compared with chi-squared tests.

Time frame
At the end of the 12- week switch phase
2

Complete switching rate (Aim 1)

Will be compared between arms using logistic regression analysis, adjusting for baseline variables as needed.

Time frame
At the end of the 12-week switch phase
3

Abstinence from cigarettes (Aim 1)

Will be compared between arms using logistic regression analysis, adjusting for baseline variables as needed.

Time frame
At the end of the 12-week switch phase
4

Cigarettes smoked per day (Aim 1)

If needed, will apply a normalizing transformation to the number of cigarettes smoked per day (e.g., taking the logarithm) before proceeding with the analysis as a means of removing the effects of potential outliers. Will compare cigarettes smoked per day between the two arms using linear regression analysis. The model will adjust for cigarettes smoked per day at baseline and other baseline variables if they are imbalanced.

Time frame
At the end of the 12-week switch phase

Secondary outcomes

Other outcomes

Sponsors and contacts

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

Ohio State University Comprehensive Cancer Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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