NCT03272685

Impact of Very Low Nicotine Content Cigarettes in a Complex Marketplace

Impact of Very Low Nicotine Content Cigarettes in a Complex Marketplace Part of "Evaluating New Nicotine Standards for Cigarettes"

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 799 (actual)
• Sponsor: University of Minnesota · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

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.

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 nicotine/g tobacco) along with non-combusted tobacco/nicotine products or 2) normal nicotine content cigarettes (NNC; 15.8 mg nicotine/g tobacco) along with non-combusted tobacco/nicotine products. Smokers will undergo an orientation visit for screening and then enter a three phase experimental trial: 1. Phase 1 - Baseline: Two week baseline assessment period during usual brand cigarette smoking. 2. 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; 3. 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).

Conditions

• Tobacco Smoking
• Nicotine Dependence

Interventions

Type	Name	Description
DRUG	Very Low Nicotine Content Cigarettes	0.4 mg nicotine/g tobacco; 9 mg tar
DRUG	Normal Nicotine Content Cigarettes	15.8 mg nicotine/g tobacco; 9 mg tar

Timeline

• Start date: 2018-06-01
• Primary completion: 2022-09-30
• Completion: 2023-01-10
• First posted: 2017-09-05
• Last updated: 2024-08-20
• Results posted: 2024-08-20

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study