N/A
N=150
Methods Project 4: Clinical Trial
Smoker
Bottom Line
View on ClinicalTrials.gov: NCT01867242 ↗Enrolled (actual)
150
Serious AEs
0.7%
Results posted
Apr 2023
Primary outcome: Primary: Smoke-free Days — 14.5; 0; 0 days
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cigarettes (Other); Snus (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Minnesota
- Primary completion
- Feb 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Smoke-free Days |
14.5; 0; 0 | — |
| SECONDARY CEMA (2-cyanoethylmercapturic Acid) |
248.1; 438.8; 594.6 | — |
| SECONDARY Total Nicotine Exposure |
46.7; 65.0; 63.4 | — |
| SECONDARY Urinary Total NNAL |
1.43; 1.27; 1.38 | — |
Summary
Cigarette smokers who are eligible will enter a Camel Snus sampling phase. Smokers interested in continuing with the study after the sampling phase will undergo a 2 week baseline assessment phase and will then be randomized to one of the three experimental conditions for 8 weeks. Tobacco use patterns, subjective responses to product, and nicotine and toxicant exposure will be assessed.
Eligibility Criteria
Inclusion Criteria
- Male or female subjects who are at least 18 years of age;
- Daily smoker;
- Generally good health;
- Subject has provided written informed consent to participate in the study (adolescents under the age of 18 will be excluded because this project involves continued use of tobacco products and new tobacco products);
Exclusion Criteria
- Unstable health
- Pregnant or breastfeeding (due to toxic effects from tobacco products).
- Unable to read for comprehension or completion of study documents.
Data sourced from ClinicalTrials.gov (NCT01867242). 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.