Reduced Nicotine Content Cigarettes and Tobacco Switching Behaviors
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| ClinicalTrials.gov Identifier: NCT02000921 |
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Recruitment Status :
Completed
First Posted : December 4, 2013
Results First Posted : March 31, 2017
Last Update Posted : March 31, 2017
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Tobacco Addiction Dual Tobacco Use | Other: VLNC cigarettes Other: Combusted Products Other: Non-combusted products Other: CN cigarettes | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 136 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Other |
| Official Title: | Models for Tobacco Productive Evaluation: Reduced Nicotine Content Cigarettes and Tobacco Switching Behaviors |
| Study Start Date : | December 2013 |
| Actual Primary Completion Date : | September 2015 |
| Actual Study Completion Date : | September 2016 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: 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.
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Other: Combusted Products
Options for combusted tobacco products include cigars, cigarillos, and little cigars, . Other: Non-combusted products Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine. Other: CN cigarettes Experimental cigarettes with conventional nicotine content. |
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Experimental: 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.
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Other: VLNC cigarettes
Modified risk tobacco product
Other Name: Very Low Nicotine Content Cigarettes Other: Combusted Products Options for combusted tobacco products include cigars, cigarillos, and little cigars, . Other: Non-combusted products Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine. |
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Experimental: 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.
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Other: VLNC cigarettes
Modified risk tobacco product
Other Name: Very Low Nicotine Content Cigarettes Other: Non-combusted products Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine. |
- Number of Days Using Alternative Products [ Time Frame: 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 [ Time Frame: 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.
- Rate of 24 Hour Quit Attempts [ Time Frame: 8 week intervention period ]Rate of 24 hour quit attempts during the intervention period
- Carcinogen Exposure Biomarker: Total NNAL [ Time Frame: Week 8 (end of intervention) ]Total NNAL (pmol/mg creatinine) is a measure of carcinogen exposure assessed at the end of intervention.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02000921
| United States, Minnesota | |
| University of Minnesota Tobacco Research Program | |
| Minneapolis, Minnesota, United States, 55414 | |
| Principal Investigator: | Dorothy K Hatsukami, PhD | University of Minnesota |
| Responsible Party: | University of Minnesota |
| ClinicalTrials.gov Identifier: | NCT02000921 |
| Other Study ID Numbers: |
2013NTLS012 U19CA157345 ( U.S. NIH Grant/Contract ) |
| First Posted: | December 4, 2013 Key Record Dates |
| Results First Posted: | March 31, 2017 |
| Last Update Posted: | March 31, 2017 |
| Last Verified: | February 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
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Cigarette Smoking Very Low Nicotine Content cigarettes (VLNC) Dual Tobacco Use |
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Behavior, Addictive Compulsive Behavior Impulsive Behavior Nicotine Ganglionic Stimulants Autonomic Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Nicotinic Agonists Cholinergic Agonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |