THRIVE Study: Understanding How Oral Nicotine Pouches Affect Public Health

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age21+
SponsorOhio State University Comprehensive Cancer Center

About this trial

Although nicotine pouches have been gaining popularity over the last few years, little known about how nicotine pouch users actually use these products.

This study will be comprised of adults who use nicotine pouches. If eligible, participants will be asked to complete three study visits and participate in two switching periods where participants use study-provided nicotine pouches.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age 21 or older

Able to read and speak English

Willing to abstain from tobacco, nicotine, and marijuana for at least 12 hours prior to study visits

Exclusive use of ONPs (other product use <10x/mo).

Disqualifiers

Non-English speaker

Individuals currently pregnant, planning to become pregnant, or breastfeeding are excluded due to potential risks associated with nicotine exposure and study procedures (e.g., blood draws).

Individuals with unstable or significant psychiatric conditions are excluded to minimize risk and ensure reliable participation.

Individuals actively attempting to quit nicotine use are excluded to avoid ethical concerns and ensure that study participation does not interfere with cessation efforts

Trial design

Design model

Parallel

Treatments tested in this trial

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood sample collection

  • Nicotine Oral Pouch

    Drug

    Insert small particle size ONP

  • Nicotine Oral Pouch

    Drug

    Insert variable particle size ONP

  • Survey Administration

    Other intervention

    Ancillary studies

  • Text Message-Based Navigation Intervention

    Other intervention

    Receive text with a link to daily diary surveys

Treatment groups

15 Participants
are divided into 2 treatment groups
Group A: Small particle size oral nicotine pouchesExperimental treatment 4 interventions
Group B: Variable particle size oral nicotine pouchesExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Nicotine Delivery, Cmax

Nicotine delivery will be summarized by Cmax, the maximum nicotine concentration observed in the plasma samples for each participant.

Time frame
2 weeks

Secondary outcomes

1

Switching Behavior

Switching behavior will be quantified using the number of days during the switching week that each participant completely switches from their usual ONP to the study product.

Time frame
2 weeks
2

Nicotine Delivery, Tmax

The time at which the maximum nicotine concentration is observed in the plasma samples for each participant.

Time frame
2 weeks
3

Nicotine Delivery, AUC

Area under the curve (AUC) of plasma nicotine levels versus time for each participant.

Time frame
2 weeks
4

Craving Relief, QSU

Urges/craving will be measured using a modified version of the Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form (QSU). This is a 10-item measure where participants rate items on a 7-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree). Similar to previous studies, the investigators will collapse the items into two previously identified factors (Factor 1: strong desire and intention to use; Factor 2: anticipation of relief from withdrawal symptoms). Scores are calculated by summing the items and range from 5 to 35 for each of the factors with higher scores indicating greater craving.

Time frame
2 weeks

Other outcomes

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