N/A
N=136
Reduced Nicotine Content Cigarettes and Tobacco Switching Behaviors
Tobacco Addiction · Dual Tobacco Use
Bottom Line
View on ClinicalTrials.gov: NCT02000921 ↗Enrolled (actual)
136
Serious AEs
0.7%
Results posted
Mar 2017
Primary outcome: Primary: Number of Days Using Alternative Products — 14; 26; 20 Number of days
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- VLNC cigarettes (Other); Combusted Products (Other); Non-combusted products (Other); CN cigarettes (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Minnesota
- Primary completion
- Sep 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Days Using Alternative Products |
14; 26; 20 | — |
| PRIMARY Number of Combusted Products Smoked |
19.2; 12.9; 13.5 | — |
| SECONDARY Rate of 24 Hour Quit Attempts |
2; 12; 15 | — |
| SECONDARY Carcinogen Exposure Biomarker: Total NNAL |
1.22; 0.71; 0.51 | — |
Summary
The main focus of this study is to determine the use of nicotine-containing products across the three experimental conditions. Subjects will be monitored to determine their continued use of assigned cigarettes, switching to other combusted and/or non-combusted tobacco, or cessation of all tobacco containing products.
Eligibility Criteria
Inclusion Criteria
- Male or female subjects who are at least 18 years of age with a history of regular smoking for at least 1 year and no serious quit attempts in the last 3 months
- No unstable and significant medical or psychiatric conditions, including lack of stabilization of medications.
- Subject has provided written informed consent to participate in the study
Exclusion Criteria
- Regular use of tobacco products (including e-cigarettes) other than cigarettes
- Regular use of nicotine replacement or other tobacco cessation products for purpose of quitting.
- Pregnant or breastfeeding (due to toxic effects from tobacco products).
- Planned quit date within the next two months.
- Does not have a way that the research team can communicate with them by phone or e-mail.
- Not able to read and write English well enough to complete study activities without translation.
Data sourced from ClinicalTrials.gov (NCT02000921). 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.