Impact of Very Low Nicotine Content Cigarettes in a Complex Marketplace
Study Details
Study Description
Brief Summary
This project will examine the impact of very low nicotine content (VLNC) cigarettes in a complex tobacco and nicotine product marketplace. We will compare the number of cigarettes smoked and cigarette-free days in an experimental marketplace that contains VLNC cigarettes versus normal nicotine content (NNC) cigarettes.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 3 |
Detailed Description
This randomized, open label, controlled, multi-site study will simulate a "real world" tobacco environment by providing participants access to an experimental marketplace where they will be given vouchers for a specified number of points that can be exchanged for study cigarettes (varying in nicotine content described below) and non-combusted tobacco/nicotine products (smokeless tobacco, snus, electronic cigarette, medicinal nicotine replacement) and at the end of the study can exchange unspent points for money.
Subjects (N=200 in each group) will be randomly assigned to: 1) very low nicotine content cigarettes (VLNC; 0.4 mg/g) along with non-combusted tobacco/nicotine products or 2) normal nicotine content cigarettes (NNC; 15.8 mg/g) along with non-combusted tobacco/nicotine products.
Smokers will undergo an orientation visit for screening and then enter a three phase experimental trial:
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Phase 1 - Baseline: Two week baseline assessment period during usual brand cigarette smoking.
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Phase 2 - Marketplace Adaptation: Two week period where subjects have access to the marketplace that provides their preferred usual brand cigarettes and selected non-combusted tobacco products to allow the subject to adjust to the marketplace prior to randomization;
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Phase 3 - Intervention: Randomization to a marketplace with access to either VLNC or NNC cigarettes plus non-combusted products for a 12 week period.
Biomarker samples are collected at baseline, end of Phase 2 and end of week Phase 3 (week 12).
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Very Low Nicotine Content Cigarettes Very low nicotine content cigarettes (0.4 mg/g nicotine; 9 mg of tar) |
Drug: Very Low Nicotine Content Cigarettes
0.4 mg/g nicotine; 9 mg tar
Other Names:
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Active Comparator: Normal Nicotine Content Cigarettes Normal (Conventional) Nicotine Content (15.8 mg/g nicotine; 9 mg of tar) |
Drug: Normal Nicotine Content Cigarettes
15.8 mg/g nicotine; 9 mg tar
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Cigarettes Per Day (CPD) [7 days prior to end of Phase 2 and the end of Week 12 (12 weeks on study cigarettes)]
The mean cigarettes (study and non-study cigarettes) smoked per day based on 7 days Daily Interactive Voice Response (IVR) data at the end of Phase 3 (experimental marketplace with study cigarettes) compared to Phase 2 (experimental marketplace with usual brand cigarettes).
- Smoke-free Days [12 weeks on study cigarettes]
Rate of smoke-free days, defined as no cigarettes smoked in the past 24 hours calculated as the proportion of smoke-free days out of the total number of days in Phase 3.
Secondary Outcome Measures
- Percent Change in 2-cyanoethyl-mercapturic Acid (CEMA) [12 weeks (Phase 3) on study cigarettes]
Change in CEMA (biomarker for the mercapturic acid acrylonitrile) from end of Phase 2 (experimental marketplace with usual brand cigarettes) to end of Phase 3 (experimental marketplace with study cigarettes).
- Study Cigarettes Per Day [12 weeks (Phase 3) on study cigarettes]
The mean study cigarettes smoked per day based on 7 days Daily Interactive Voice Response (IVR) data at the end of Phase 3 (experimental marketplace with study cigarettes) compared to Phase 2 (experimental marketplace with usual brand cigarettes).
- Seven-day Abstinence from Cigarettes [7 days]
Total cigarettes per day equal to 0 for all 7 days before the week 12 visit and carbon monoxide (CO) ≤ 6ppm at week 12.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male or female;
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At least 21 years of age;
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Biochemically confirmed smoker.
Exclusion Criteria:
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Unstable health condition;
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Unstable medications;
- Pregnant or nursing.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Tobacco Research Center | San Francisco | California | United States | 94110 |
2 | Tobacco Research Programs | Minneapolis | Minnesota | United States | 55414 |
3 | Tobacco | Durham | North Carolina | United States | 27705 |
4 | Wake Forest Tobacco Control Center of Excellence | Winston-Salem | North Carolina | United States | 27175 |
5 | Center for Interdisciplinary Research on Nicotine Addiction | Philadelphia | Pennsylvania | United States | 19104 |
6 | Brown University Center for Alcohol and Addiction Studies School of Public Health | Providence | Rhode Island | United States | 02912 |
Sponsors and Collaborators
- University of Minnesota
- Duke University
- University of California, San Francisco
- Wake Forest University
- University of Pennsylvania
- Brown University
Investigators
- Principal Investigator: Dorothy Hatsukami, PHD, University of Minnesota
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2017NTLS107