Smoking ( Cigarette)
Conditions
Brief summary
Some people who smoke cigarettes try to switch to oral nicotine pouches but are not able to fully stop smoking. This study tests two new strategies for people who previously tried to switch using nicotine pouches. Participants who were unable to fully switch will either be asked to increase the nicotine strength of their pouches or to use a nicotine patch along with pouches. The goal of the study is to see whether these strategies are feasible, acceptable, and helpful, and to inform the design of larger future studies.
Interventions
DRUGNicotine replacement therapy patches
Nicotine replacement therapy patches will be dosed based on current cigarette smoking at the end of the parent trial.
Zyn oral nicotine pouches will be provided in the flavor preference of the participant and dosed based on their randomization in the parent trial and randomization in the extension study.
Sponsors
Medical University of South Carolina
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 21 years or older * Currently enrolled in and completed the Pack2Pouch parent study * Current combustible tobacco smoking at extension study enrollment * Able to attend in-person visits in the Charleston, SC area * Access to internet and mobile communication
Exclusion criteria
* Pregnancy, breastfeeding, or nursing * Medical contraindications to nicotine replacement therapy * Current use of smoking cessation medications * Non-English proficiency * Use of other combustible tobacco or frequent non-combustible nicotine products outside study protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility | Days 1-56 | Feasibility endpoints include 1) the proportion of eligible subjects who subsequently enroll; 2) the proportion of enrolled subjects who complete the Day 28 and Day 56 assessments; and 3) the proportion of enrolled subjects who complete ≥80% of their daily surveys during the switching period. |
| Acceptability | Day 28 | Acceptability endpoints will be measured by the Acceptability of Intervention Measure (AIM). This measure includes 4 items rated on scale of 1 to 5. Scores are created by averaging responses, with values ranging from 1 to 5. Higher values indicate higher acceptability. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAmanda Palmer, PhD
Medical University of South Carolina
Outcome results
None listed