Noncombustible Nicotine Delivery Systems as Potential Harm Reduction Tools for Persistent
This between-subjects study aims to evaluate whether e-cigarettes (ECIGS) versus oral nicotine pouches (ONPS) more readily substitute for combustible cigarettes among 200 cigarette smokers. After measuring baseline cigarette smoking rate, participants will be randomized to ECIGS or ONPS and be instructed to switch (ver
| Condition(s) | E-cigarette Use, Cigarette Smoking, Harm Reduction, Tobacco Use |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | This between-subjects study aims to evaluate whether e-cigarettes (ECIGS) versus oral nicotine pouches (ONPS) more readily substitute for combustible cigarettes among 200 cigarette smokers. After measuring baseline cigarette smoking rate, participants will be randomized to ECIGS or ONPS and be instructed to switch (versus smoking cigarettes) over a 6-week period. Relative reductions in biomarkers of exposure will be measured. ECIG- and ONP-associated subjective reward and the reinforcing value of ECIGS and ONPS relative to combustible cigarettes will be assessed as mechanisms. |
| Who can participate | Inclusion Criteria: 1. Able to communicate fluently in English (i.e. speaking, writing, and reading) 2. Male and female smokers who are \> 21 years of age and self-report smoking at least 5 cigarettes (menthol and/or non-menthol) per day for at least the last 6 months. 3. 5 or more failed quit attempts and the use of smoking cessation medication on at least one prior attempt. 4. Have a carbon monoxide (CO) greater than 10 ppm. 5. Not using any forms of nicotine regularly other than cigarettes 6. Be willing to switch to e-cigarettes or nicotine pouches for 6 weeks. 7. Plan to live in the area for the duration of the study. 8. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the combined consent and HIPAA form. Exclusion C |
| Ages | 21 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | Abramson Cancer Center at Penn Medicine |
| Locations | Philadelphia, Pennsylvania, United States |
| Start date | 2024-10-02 |
| NCT ID | NCT06372899 |
| Official listing | https://clinicaltrials.gov/study/NCT06372899 |