Smoker
Conditions
Keywords
cigarette, snus, smoking, tobacco
Brief 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.
Detailed description
Baseline smoking period: Subjects will be required to attend 2 baseline clinic visits where baseline assessments will be captured including a record of their cigarette or other tobacco intake on a daily basis using an interactive voice response system (IVR). Experimental Period: After the baseline assessment, subjects will be randomized to one of five experimental conditions: 1) smoking usual brand cigarette controls, who after 8-weeks will be offered Camel Snus to use as they will for 8 more weeks; 2) complete substitution (i.e., no smoking) and use snus instead ; 3) partial substitution - use of both snus and cigarettes as you like. Snus, but not cigarettes, will be provided to subjects at the clinic visits. Subjects will attend clinic visits over the next 8 weeks where tobacco use patterns and biomarker data will be collected.
Interventions
OTHERCigarettes
Smoke their usual brand of cigarettes and follow their normal patterns of use.
OTHERSnus
Winterchill or Robust flavors
Sponsors
National Cancer Institute (NCI)
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Smoke-free Days | 8 weeks (56 (+/-5) days) | Number of days subjects smoked no cigarettes during the intervention was compared between groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CEMA (2-cyanoethylmercapturic Acid) | 8 weeks | 2-cyanoethylmercapturic acid (CEMA) is a biomarker for exposure to acrylonitrile, a volatile organic compound, and is sensitive to changes in cigarette smoke exposure. |
| Total Nicotine Exposure | 8 weeks | Urinary total nicotine equivalents, the molar sum of nicotine and six metabolites, accounts for more than 90% of a nicotine dose |
| Urinary Total NNAL | 8 weeks | Urinary 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol and its glucuronides (total NNAL) is a metabolite of 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK), one of the group of chemicals termed tobacco-specific N-nitrosamines (TSNA) |
Countries
United States
Participant flow
Recruitment details
Smokers were recruited from Minneapolis, Minnesota; Columbus and Coshocton, Ohio, and Buffalo, New York between May 2013 and August 2016. Internet and local media advertisements read: Smokers who want to try a new oral tobacco product are needed for a research study that may reduce their exposure to harmful tobacco smoke.
Pre-assignment details
After 1 week, participants returned to the clinic with snus tins and unused snus pouches. Tobacco use over the past week was assessed and participants completed self-report questionnaires. Participants who used at least seven snus pouches (based on potential use of one pouch per day) and continued to smoke were eligible to enter the clinical trial. These criteria were withheld from participants to ensure an unbiased willingness to use snus.
Participants by arm
| Arm | Count |
|---|---|
| Complete Substitution Use snus in place of cigarettes
Snus: Winterchill or Robust flavors | 64 |
| Partial Substitution (Snus and Cigarettes) Use snus and cigarettes how ever you like
Cigarettes: Smoke their usual brand of cigarettes and follow their normal patterns of use.
Snus: Winterchill or Robust flavors | 60 |
| Usual Brand Cigarette Smoking usual brand cigarette controls, who after 8-weeks will be offered Camel Snus and instructed for partial or complete substitution of cigarettes (subject's choice);
Cigarettes: Smoke their usual brand of cigarettes and follow their normal patterns of use. | 26 |
| Total | 150 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to follow-up, personal reasons | 24 | 16 | 8 |
Baseline characteristics
| Characteristic | Partial Substitution (Snus and Cigarettes) | Total | Usual Brand Cigarette | Complete Substitution |
|---|---|---|---|---|
| Age, Continuous | 42.0 years | 43.5 years | 47.0 years | 42.5 years |
| Fagerstrom Test for Nicotine Dependence (FTND) | 3.0 units on a scale | 3.0 units on a scale | 3.0 units on a scale | 3.0 units on a scale |
| Mean cigarettes per day (CPD) | 11.7 Cigarettes Per Day | 12.3 Cigarettes Per Day | 12.1 Cigarettes Per Day | 14.0 Cigarettes Per Day |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 16 Participants | 43 Participants | 11 Participants | 16 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 5 Participants | 0 Participants | 4 Participants |
| Race (NIH/OMB) White | 43 Participants | 102 Participants | 15 Participants | 44 Participants |
| Region of Enrollment United States | 60 participants | 150 participants | 26 participants | 64 participants |
| Sex: Female, Male Female | 24 Participants | 65 Participants | 13 Participants | 28 Participants |
| Sex: Female, Male Male | 36 Participants | 85 Participants | 13 Participants | 36 Participants |
| Total Nicotine Equivalents (TNE) | 55.9 nmol/mg | 59.1 nmol/mg | 65.7 nmol/mg | 58.3 nmol/mg |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 64 | 0 / 60 | 0 / 26 |
| other Total, other adverse events | 5 / 64 | 1 / 60 | 0 / 26 |
| serious Total, serious adverse events | 1 / 64 | 0 / 60 | 0 / 26 |
Outcome results
Primary
Smoke-free Days
Number of days subjects smoked no cigarettes during the intervention was compared between groups.
Time frame: 8 weeks (56 (+/-5) days)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Complete Substitution | Smoke-free Days | 14.5 days |
| Partial Substitution (Snus and Cigarettes) | Smoke-free Days | 0 days |
| Usual Brand Cigarette | Smoke-free Days | 0 days |
Secondary
CEMA (2-cyanoethylmercapturic Acid)
2-cyanoethylmercapturic acid (CEMA) is a biomarker for exposure to acrylonitrile, a volatile organic compound, and is sensitive to changes in cigarette smoke exposure.
Time frame: 8 weeks
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Complete Substitution | CEMA (2-cyanoethylmercapturic Acid) | 248.1 pmol/mg per creatinine |
| Partial Substitution (Snus and Cigarettes) | CEMA (2-cyanoethylmercapturic Acid) | 438.8 pmol/mg per creatinine |
| Usual Brand Cigarette | CEMA (2-cyanoethylmercapturic Acid) | 594.6 pmol/mg per creatinine |
Secondary
Total Nicotine Exposure
Urinary total nicotine equivalents, the molar sum of nicotine and six metabolites, accounts for more than 90% of a nicotine dose
Time frame: 8 weeks
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Complete Substitution | Total Nicotine Exposure | 46.7 nmol/mg |
| Partial Substitution (Snus and Cigarettes) | Total Nicotine Exposure | 65.0 nmol/mg |
| Usual Brand Cigarette | Total Nicotine Exposure | 63.4 nmol/mg |
Secondary
Urinary Total NNAL
Urinary 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol and its glucuronides (total NNAL) is a metabolite of 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK), one of the group of chemicals termed tobacco-specific N-nitrosamines (TSNA)
Time frame: 8 weeks
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Complete Substitution | Urinary Total NNAL | 1.43 pmol/mg creatinine |
| Partial Substitution (Snus and Cigarettes) | Urinary Total NNAL | 1.27 pmol/mg creatinine |
| Usual Brand Cigarette | Urinary Total NNAL | 1.38 pmol/mg creatinine |