N/A
N=47
Effect of Banning Menthol Flavorant on Cigarette and E-Cigarette Use
Tobacco Use Disorder
Bottom Line
View on ClinicalTrials.gov: NCT03402243 ↗Enrolled (actual)
47
Serious AEs
0.0%
Results posted
Aug 2021
Primary outcome: Primary: Amount of Tobacco Product Used — 13.1; 18.6; 15.3; 56.7 tobacco products use per day — p=0.349
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Menthol ban on cigarettes (Other); Menthol ban on cigarettes and e-cigarettes (Other); No menthol ban (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Minnesota
- Primary completion
- Mar 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Amount of Tobacco Product Used |
13.1; 18.6; 15.3; 56.7; 10.7; 4.5 | 0.349 |
| SECONDARY How Much of Each Product is Obtained From the "Experimental Marketplace" |
22.6; 29.3; 28.8; 3.13; 1.2; 1.06 | 0.185 |
| SECONDARY Motivation to Quit Smoking Cigarettes |
3.6; 3.1; 3.2 | 0.27 |
Summary
In this pilot study, menthol cigarette smokers will be randomized to one of three experimental marketplaces: 1) a condition simulating a ban on menthol cigarettes but not menthol e-cigarettes (condition A); 2) a condition simulating a ban on both menthol cigarettes and menthol e-cigarettes (Condition B); and 3) a condition in which menthol is not banned for either product (Condition C - the control condition). All conditions would have medicinal nicotine available if subjects decide to quit tobacco products entirely. At visits occurring every two weeks over a 6 week period, subjects will receive "credits" that they could exchange for any product available in their randomized marketplace condition. Outcomes include the amount of each tobacco product used.
Eligibility Criteria
Inclusion Criteria
- Be between the ages of 18 and 64
- Purchase exclusively menthol cigarettes
- Not currently motivated to quit smoking
- Smoking a minimum number of cigarettes per day
Exclusion Criteria
- Report a serious, unstable medical or psychiatric condition
- Use any medications that might interfere with measures to be studied (for example, medications known to affect smoking)
- Have used any smoking cessation therapy during the past month
- Regularly use any form of tobacco other than cigarettes
- Are pregnant or breast feeding or planning to become pregnant or breast feed during the study
Data sourced from ClinicalTrials.gov (NCT03402243). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.