Trials / Withdrawn
WithdrawnNCT03699865
Young Adults and Low Nicotine Cigarettes
- Status
- Withdrawn
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Abramson Cancer Center at Penn Medicine · Academic / Other
- Sex
- All
- Age
- 21 Years – 29 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to look at the effects of investigational low nicotine cigarettes on young adult smokers. The investigators are interested in how using these products affects young adults' perceptions and smoking behaviors. This research may help inform the Food and Drug Administration (FDA) how best to regulate tobacco products in the future with the goal of improving public health.
Detailed description
Investigators will recruit 100 young adult cigarette smokers to a 40-day, laboratory-based protocol. You will provide and smoke your preferred brand cigarettes for an initial 5-day baseline period, then receive your own brand free-of-charge for an additional 5-day period, and then will receive free, investigational low nicotine cigarettes for the remaining study duration (i.e., 30 days total). Low nicotine cigarettes will be provided in three varieties; each variety will be used for a 10-day period, in counterbalanced order. Primary outcomes will include smoking behaviors (daily cigarette consumption and total puff volume), harm perceptions (i.e., beliefs about product safety), and tobacco exposure (i.e., carbon monoxide \[CO\]). You will complete in-person visits at the Center for Interdisciplinary Research on Nicotine Addiction (CIRNA) every 5 days, for a total of nine in-person visits.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Nicotine content | Study-supplied cigarettes will contain either intermediate or very low nicotine content |
Timeline
- Start date
- 2024-10-01
- Primary completion
- 2024-10-01
- Completion
- 2024-10-01
- First posted
- 2018-10-09
- Last updated
- 2024-10-15
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT03699865. Inclusion in this directory is not an endorsement.