N/A
N=31
Impact of Exclusive Use of Low Nicotine Cigarettes on Compensatory Smoking
Smoking
Bottom Line
View on ClinicalTrials.gov: NCT03311646 ↗Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcome: Primary: Breath Sample (Expired Carbon Monoxide) — 18.77; 31.07; 25.38; 30.49 parts per million — p=0.92
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Normal nicotine content cigarettes (NNC, Baseline) (Other); Very low nicotine content (VLNC) (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medical University of South Carolina
- Primary completion
- Nov 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Breath Sample (Expired Carbon Monoxide) |
18.77; 31.07; 25.38; 30.49; 36.72; 35.66 | 0.92 |
| PRIMARY Average Cigarettes Smoked Per Day |
19.13; 22.38; 20.13; 20.69 | 0.15 |
| SECONDARY Minnesota Nicotine Withdrawal Scale |
23.94; 24.19; 23.69; 25.00 | <0.001 sig |
| SECONDARY Questionnaire of Smoking Urges |
19.94; 21.31; 20.00; 18.94 | 0.84 |
Summary
Smoking is the leading cause of preventable death in the United States. An FDA-mandated reduction in the nicotine content of cigarettes might reduce the health burden of tobacco by reducing the prevalence of smoking. The proposed project will test the impact of nicotine reduction on smoking behavior and smoke exposure in a setting where participants are restricted from using their usual brand cigarettes.
Eligibility Criteria
Inclusion Criteria
- male or female participants who are least 18 years old and smoke daily
- willing to stay in a hotel for two four-night stays during the prearranged dates
Exclusion Criteria
- unwilling to use research cigarettes as part of the trial
- pregnant, trying to become pregnant, or breastfeeding
- additional smoking and health criteria determined at screening
Data sourced from ClinicalTrials.gov (NCT03311646). 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.