An interventional study of VLNC cigarettes and Combusted Products in Tobacco Addiction and Dual Tobacco Use, sponsored by University of Minnesota. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-03-31.
Sponsored by University of Minnesota · Not applicable, Interventional, and Other
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.
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.
540 studies on the registry are indexed under Behavior, Addictive; 134 are open to participants now.
This study's enrollment of 136 is above the median of 72 across 391 interventional studies indexed under Behavior, Addictive.
Browse Behavior, Addictive studies →University of Minnesota is the lead sponsor of 1,184 studies on the registry; 195 are open to participants now.
Of its 132 completed or terminated interventional studies of FDA-regulated products, 91 (69%) have results posted.
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Exclusion Criteria:
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.
Other: Combusted Products · Other: Non-combusted products · Other: CN cigarettes
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.
Other: VLNC cigarettes · Other: Combusted Products · Other: 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.
Other: VLNC cigarettes · Other: Non-combusted products
Modified risk tobacco product
Also known as: Very Low Nicotine Content Cigarettes
Options for combusted tobacco products include cigars, cigarillos, and little cigars, .
Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine.
Experimental cigarettes with conventional nicotine content.
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
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)
Rate of 24 Hour Quit Attempts
Rate of 24 hour quit attempts during the intervention period
Time frame: 8 week intervention period
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)
| Milestone | CN + Combusted & Non-combusted Products | VLNC + Combusted & Non-combusted Products | VLNC With Non-combusted Products |
|---|---|---|---|
| Started | 27 | 53 | 56 |
| Completed | 22 | 37 | 46 |
| Not completed | 5 | 16 | 10 |
| Withdrew: Withdrawal by subject | 3 | 10 | 5 |
| Withdrew: Lost to follow-up | 2 | 4 | 5 |
| Withdrew: Physician decision | 0 | 2 | 0 |
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 days | CN + Combusted & Non-combusted Products | VLNC + Combusted & Non-combusted Products | VLNC With Non-combusted Products |
|---|---|---|---|
| Number of Days Using Alternative Products | 14 ± 17 | 26 ± 19 | 20 ± 19 |
Number of combusted products smoked per day during the last two weeks of the intervention period.
| combuster products per day | CN + Combusted & Non-combusted Products | VLNC + Combusted & Non-combusted Products | VLNC With Non-combusted Products |
|---|---|---|---|
| Number of Combusted Products Smoked | 19.2 ± 8.1 | 12.9 ± 7.6 | 13.5 ± 9.8 |
Rate of 24 hour quit attempts during the intervention period
| Participants | CN + Combusted & Non-combusted Products | VLNC + Combusted & Non-combusted Products | VLNC With Non-combusted Products |
|---|---|---|---|
| Rate of 24 Hour Quit Attempts | 2 | 12 | 15 |
Total NNAL (pmol/mg creatinine) is a measure of carcinogen exposure assessed at the end of intervention.
| pmol//mg creatinine | CN + Combusted & Non-combusted Products | VLNC + Combusted & Non-combusted Products | VLNC With Non-combusted Products |
|---|---|---|---|
| Carcinogen Exposure Biomarker: Total NNAL | 1.22 (0.91 to 1.65) | 0.71 (0.41 to 1.23) | 0.51 (0.35 to 0.74) |
Collected over During the 8 week intervention. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CN + Combusted & Non-combusted Products | — | 0/27 (0%) | 6/27 (22.2%) |
| VLNC + Combusted & Non-combusted Products | — | 0/53 (0%) | 7/53 (13.2%) |
| VLNC With Non-combusted Products | — | 1/56 (1.8%) | 23/56 (41.1%) |
| Event | CN + Combusted & Non-combusted Products | VLNC + Combusted & Non-combusted Products | VLNC With Non-combusted Products |
|---|---|---|---|
| HospitalizationRespiratory, thoracic and mediastinal disorders | 0/27 | 0/53 | 1/56 |
| Event | CN + Combusted & Non-combusted Products | VLNC + Combusted & Non-combusted Products | VLNC With Non-combusted Products |
|---|---|---|---|
| CoughRespiratory, thoracic and mediastinal disorders | 2/27 | 0/53 | 8/56 |
| HeadacheGeneral disorders | 0/27 | 7/53 | 5/56 |
| Sore throatGeneral disorders | 0/27 | 0/53 | 7/56 |
| IrritabilityGeneral disorders | 2/27 | 0/53 | 0/56 |
| Difficulty concentratingGeneral disorders | 2/27 | 0/53 | 0/56 |
| nauseaGastrointestinal disorders | 0/27 | 0/53 | 3/56 |
| Age, Categorical(Participants) | CN + Combusted & Non-combusted Products | VLNC + Combusted & Non-combusted Products | VLNC With Non-combusted Products | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 3 | 3 |
| Between 18 and 65 years | 26 | 48 | 49 | 123 |
| >=65 years | 1 | 5 | 4 | 10 |
| Age, Continuous(years) | CN + Combusted & Non-combusted Products | VLNC + Combusted & Non-combusted Products | VLNC With Non-combusted Products | Total |
|---|---|---|---|---|
| Mean | 43 ± 14 | 44 ± 15 | 45 ± 15 | 44 ± 14 |
| Sex: Female, Male(Participants) | CN + Combusted & Non-combusted Products | VLNC + Combusted & Non-combusted Products | VLNC With Non-combusted Products | Total |
|---|---|---|---|---|
| Female | 11 | 29 | 29 | 69 |
| Male | 16 | 24 | 27 | 67 |
| Region of Enrollment(Participants) | CN + Combusted & Non-combusted Products | VLNC + Combusted & Non-combusted Products | VLNC With Non-combusted Products | Total |
|---|---|---|---|---|
| United States | 27 | 53 | 56 | 136 |
Plan to share: No
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