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Summary

for people ages 18 years and up (full criteria)
healthy people welcome
study started
estimated completion:

Description

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, use of alternative nicotine-containing products, biomarkers of toxicant exposure and days abstinence from cigarettes in an experimental marketplace that contains VLNC cigarettes versus normal nicotine content (NNC) cigarettes.

Official Title

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

Details

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) or cash. More specifically, subjects (N=350 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:

  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 12 (Phase 3).

Keywords

Tobacco Smoking Nicotine Dependence Reduced nicotine cigarettes Alternative nicotine products Biomarkers of tobacco exposure Tobacco Use Disorder Nicotine

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Male or female;
  2. At least 18 years at University of MN or Duke University or 21 years of age at University of California, San Francisco;
  3. Biochemically confirmed smoker.

You CAN'T join if...

  1. Unstable health condition;
  2. Unstable medications;
  3. Positive drug screen (except for marijuana);
  4. Pregnant or nursing.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of Minnesota - Clinical and Translational Science Institute
ID
NCT03272685
Phase
Phase 3
Study Type
Interventional
Last Updated
September 1, 2017
I’m interested in this study!