Dual Tobacco Use, Tobacco Addiction
Conditions
Keywords
Cigarette Smoking, Very Low Nicotine Content cigarettes (VLNC), Dual Tobacco Use
Brief 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.
Detailed description
This is a single site, single-blind, randomized trial with three experimental conditions tested for a period of 8 weeks: 1) Very low nicotine content (VLNC) cigarettes (0.07 nicotine yield) with access to combusted (except cigarettes) and non-combusted tobacco and medicinal nicotine products; 2) VLNC cigarettes with access to only non-combusted tobacco and medicinal nicotine products; and 3) conventional nicotine (CN) content experimental cigarettes (0.8 mg nicotine) with access to combusted and non-combusted products. This study will examine 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 (e.g., little cigars, large cigars, pipes) and/or non-combusted tobacco products (e.g., conventional smokeless tobacco, snus for smokers, dissolvables, e-cigarettes, medicinal nicotine), or cessation of all tobacco containing products. Toxicant exposure across the three conditions will also be examined. Eligible subjects will be provided very low nicotine content cigarettes and are told to use the product ad lib for 8 weeks. Subjects will complete questionnaires on demographics, smoking and health history, drug and alcohol use history, mood and perceptions of the study tobacco product. Biomarker samples will be analyzed for exposure levels of nicotine and tobacco-related toxicants.
Interventions
OTHERVLNC cigarettes
Modified risk tobacco product
OTHERCombusted Products
Options for combusted tobacco products include cigars, cigarillos, and little cigars, .
OTHERNon-combusted products
Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine.
OTHERCN cigarettes
Experimental cigarettes with conventional nicotine content.
Sponsors
National Cancer Institute (NCI)
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
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 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Days Using Alternative Products | 8 week intervetnion period | The primary aim of the study is to determine the rate of use of alternative nicotine-containing products across the three experimental conditions. |
| Number of Combusted Products Smoked | At weeks 6-8 (last two weeks of intervention period) | Number of combusted products smoked per day during the last two weeks of the intervention period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of 24 Hour Quit Attempts | 8 week intervention period | Rate of 24 hour quit attempts during the intervention period |
| Carcinogen Exposure Biomarker: Total NNAL | Week 8 (end of intervention) | Total NNAL (pmol/mg creatinine) is a measure of carcinogen exposure assessed at the end of intervention. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CN + Combusted & Non-combusted Products Subjects will be asked to smoke the assigned conventional nicotine content (CN) cigarettes, instead of their normal brand, for 8 weeks and will also be given access to use other combusted and non-combusted tobacco and medicinal nicotine products during that time.
Combusted Products: Options for combusted tobacco products include cigars, cigarillos, and little cigars, .
Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine.
CN cigarettes: Experimental cigarettes with conventional nicotine content. | 27 |
| VLNC + Combusted & Non-combusted Products Subjects will be asked to smoke the assigned very low nicotine content (VLNC) cigarettes, instead of their normal brand, for 8 weeks and will also be given access to use other combusted and non-combusted tobacco and medicinal nicotine products during that time.
VLNC cigarettes: Modified risk tobacco product
Combusted Products: Options for combusted tobacco products include cigars, cigarillos, and little cigars, .
Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine. | 53 |
| VLNC With Non-combusted Products Subjects will be asked to smoke very low nicotine content (VLNC) cigarettes instead of their usual cigarettes for an 8 week period and will be given the opportunity to use non-combusted types of tobacco and medicinal tobacco products.
VLNC cigarettes: Modified risk tobacco product
Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine. | 56 |
| Total | 136 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 4 | 5 |
| Overall Study | Physician Decision | 0 | 2 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 10 | 5 |
Baseline characteristics
| Characteristic | VLNC + Combusted & Non-combusted Products | VLNC With Non-combusted Products | CN + Combusted & Non-combusted Products | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 3 Participants | 0 Participants | 3 Participants |
| Age, Categorical >=65 years | 5 Participants | 4 Participants | 1 Participants | 10 Participants |
| Age, Categorical Between 18 and 65 years | 48 Participants | 49 Participants | 26 Participants | 123 Participants |
| Age, Continuous | 44 years STANDARD_DEVIATION 15 | 45 years STANDARD_DEVIATION 15 | 43 years STANDARD_DEVIATION 14 | 44 years STANDARD_DEVIATION 14 |
| Region of Enrollment United States | 53 Participants | 56 Participants | 27 Participants | 136 Participants |
| Sex: Female, Male Female | 29 Participants | 29 Participants | 11 Participants | 69 Participants |
| Sex: Female, Male Male | 24 Participants | 27 Participants | 16 Participants | 67 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 6 / 27 | 7 / 53 | 23 / 56 |
| serious Total, serious adverse events | 0 / 27 | 0 / 53 | 1 / 56 |
Outcome results
Primary
Number of Combusted Products Smoked
Number of combusted products smoked per day during the last two weeks of the intervention period.
Time frame: At weeks 6-8 (last two weeks of intervention period)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CN + Combusted & Non-combusted Products | Number of Combusted Products Smoked | 19.2 combuster products per day | Standard Deviation 8.1 |
| VLNC + Combusted & Non-combusted Products | Number of Combusted Products Smoked | 12.9 combuster products per day | Standard Deviation 7.6 |
| VLNC With Non-combusted Products | Number of Combusted Products Smoked | 13.5 combuster products per day | Standard Deviation 9.8 |
Primary
Number of Days Using Alternative Products
The primary aim of the study is to determine the rate of use of alternative nicotine-containing products across the three experimental conditions.
Time frame: 8 week intervetnion period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CN + Combusted & Non-combusted Products | Number of Days Using Alternative Products | 14 Number of days | Standard Deviation 17 |
| VLNC + Combusted & Non-combusted Products | Number of Days Using Alternative Products | 26 Number of days | Standard Deviation 19 |
| VLNC With Non-combusted Products | Number of Days Using Alternative Products | 20 Number of days | Standard Deviation 19 |
Secondary
Carcinogen Exposure Biomarker: Total NNAL
Total NNAL (pmol/mg creatinine) is a measure of carcinogen exposure assessed at the end of intervention.
Time frame: Week 8 (end of intervention)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| CN + Combusted & Non-combusted Products | Carcinogen Exposure Biomarker: Total NNAL | 1.22 pmol//mg creatinine |
| VLNC + Combusted & Non-combusted Products | Carcinogen Exposure Biomarker: Total NNAL | 0.71 pmol//mg creatinine |
| VLNC With Non-combusted Products | Carcinogen Exposure Biomarker: Total NNAL | 0.51 pmol//mg creatinine |
Secondary
Rate of 24 Hour Quit Attempts
Rate of 24 hour quit attempts during the intervention period
Time frame: 8 week intervention period
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CN + Combusted & Non-combusted Products | Rate of 24 Hour Quit Attempts | 2 Participants |
| VLNC + Combusted & Non-combusted Products | Rate of 24 Hour Quit Attempts | 12 Participants |
| VLNC With Non-combusted Products | Rate of 24 Hour Quit Attempts | 15 Participants |