Impact of Very Low Nicotine Content Cigarettes in a Complex Marketplace
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 700
Summary
- Conditions
- Nicotine Dependence
- Tobacco Smoking
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Phase III randomized, open label, multi-center study that will examine the impact of very low nicotine content (VLNC) cigarettes using an experimental marketplace that contains tobacco and nicotine products, simulating a real world environment. There are three phases: Phase 1 is smoking usual brand cigarettes. Phase 2 is access to a marketplace with usual brand cigarettes and other non-combusted nicotine and tobacco products. Phase 3 involves access to a marketplace with study cigarettes and other non-combusted nicotine and tobacco products.Masking: None (Open Label)Primary Purpose: Basic Science
Participation Requirements
- Age
- Between 21 years and 125 years
- Gender
- Both males and females
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 nicotin...
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=250 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: Phase 1 - Baseline: Two week baseline assessment period during usual brand cigarette smoking. 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; 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).
Tracking Information
- NCT #
- NCT03272685
- Collaborators
- Duke University
- University of California, San Francisco
- Wake Forest University
- University of Pennsylvania
- Brown University
- Investigators
- Principal Investigator: Dorothy Hatsukami, PHD University of Minnesota
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