Effect of Flavored on!® Nicotine Pouch Products on Smoking Behaviors: a SMART

Cigarette Smoking Behavior Clinical Trial

Official title: Effect of Flavored on!® Nicotine Pouch Products on Smoking Behaviors: a Sequential Multiple Assignment Randomized Controlled Trial

Status Recruiting

Clinical Trial Summary

The goal of this clinical trial is to learn about the role of flavored on!® nicotine pouch products (the research products), an oral tobacco-leaf-free product, in the replacement of cigarettes with the use of the research products among adults who smoke cigarettes. The main question it aims to answer is whether flavored (vs. non-flavored) research products generate greater reduction of cigarette smoking among adults who smoke cigarettes.

Participants will be provided with research products to use for 6 weeks. Researchers will compare the reduction in cigarette smoking between participants with access to a complete flavor profile of research products and participants with access to only the Original (non-flavored) variety of research product to see if reduction in cigarette smoking is greater among those with access to flavored research products.

Clinical Trial Description

This open label randomized controlled study (target n=400) among adults who smoke will evaluate the impact of differential availability of research products on cigarette smoking. All products will be on!® 4mg nicotine pouch products.

In this design, there are three configurations:

1. Access to complete flavor profile (Berry, Citrus, Cinnamon, Wintergreen, Mint, Coffee, and Original) for the entire six-week trial period (Group I);

2. Access to Original only for the entire six-week trial period (Group IIa); and

3. Access to Original only for the first three-week period and then access to complete flavor profile for the second three-week period (Group IIb).

This study will involve approximately 7 weeks (including the baseline period) of study participation in a home use test with daily surveys, weekly surveys, and a 6-month follow-up survey after the trial period. Approximately 400 participants will be recruited. A total of 150 participants will be randomized to Group I, 125 to Group IIa, and 125 to Group IIb.

After consenting and screening procedures, participants will be followed for 3-7 days to establish baseline measures of cigarettes smoked per day. During this baseline period at least two CO readings will be collected. Participants randomized into Group I will enter a seven-day trial period to try all flavors of research products. This trial period is intended to allow participants to identify their preferred flavor(s). After the trial period, they will then complete five additional weeks of home use testing with ad libitum product trial of research products with free choice of the flavors available in this study.

Likewise, following the baseline period, participants randomized into Group II will be provided with the Original variety of research products to use for the next three weeks. At the three-week point, participants in Group IIa will continue with the Original variety of research product for the remaining three weeks and Group IIb will switch to having access to all flavors of research products for the remaining three weeks. Group IIb will enter a seven-day trial period to try all flavors of research products (a total of seven packs - one of each flavor will be provided). This trial period is intended to allow participants to identify their preferred flavor(s). After the trial period, they will then complete two additional weeks of home use testing with ad libitum product trial of research products with free choice of the flavors available in this study.

Participants will be invited to complete a six-month follow-up survey to gain insights about their tobacco use and related factors after the end of the product trial.

Analysis will be conducted to compare outcomes between:

1. Group I vs. Group II at week 3

2. Group I vs. Group IIa at week 6

3. Group IIa vs. Group IIb at week 6 among non-responders at week3

4. Group IIa and Group IIb at week 6 among responders at week 3

5. Group I and Groups IIb at week 6 ;

Related Conditions & MeSH terms

• Cigarette Smoking Behavior

• NCT number: NCT06072547
• Study type: Interventional
• Source: Altria Client Services LLC
• Contact: Hui Cheng, PhD
• Phone: 5175998785
• Email: hui.cheng@altria.com
• Status: Recruiting
• Phase: N/A
• Start date: September 11, 2023
• Completion date: June 2025