Clinical trial NCT03272685: Impact of Very Low Nicotine Content Cigarettes in a Complex Marketplace
Official title: Impact of Very Low Nicotine Content Cigarettes in a Complex Marketplace Part of "Evaluating New Nicotine Standards for Cigarettes"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Tobacco Smoking
Nicotine Dependence
Keywords: Reduced nicotine cigarettes
Alternative nicotine products
Biomarkers of tobacco exposure
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: Duke University
name: University of California, San Francisco
name: Wake Forest University
name: University of Pennsylvania
name: Brown University
First posted: 2017-09-05
Enrollment: 799
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: BASIC_SCIENCE

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.

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).

Eligibility criteria: Inclusion Criteria:

1. Male or female;
2. 18/21 (legal age to purchase tobacco at site);
3. Biochemically confirmed smoker.

Exclusion Criteria:

1. Unstable health condition;
2. Unstable medications;
3. Pregnant or nursing.

Primary outcomes:
measure: Cigarettes Per Day (CPD)
timeFrame: 7 days prior to week 12 visit
measure: Number of Smoke-free Days
timeFrame: day 1 of study until day before week 12 visit
Secondary outcomes:
measure: Percent Change in 2-cyanoethyl-mercapturic Acid (CEMA)
timeFrame: The last visit in Phase 2 is the end of the baseline
measure: Study Cigarettes Per Day
timeFrame: 12 weeks (Phase 3) on study cigarettes
measure: Seven Day Point-prevalence CO-verified Abstinence
timeFrame: 7 days before week 12 visit
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Tobacco Research Center
state: California
city: Minneapolis
country: United States
facility: Tobacco Research Programs
state: Minnesota
city: Durham
country: United States
facility: The Center for Addiction Science and Technology
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Tobacco Control Center of Excellence
state: North Carolina
city: Philadelphia
country: United States
facility: Center for Interdisciplinary Research on Nicotine Addiction
state: Pennsylvania
city: Providence
country: United States
facility: Brown University Center for Alcohol and Addiction Studies School of Public Health
state: Rhode Island
Study officials:
affiliation: University of Minnesota
name: Dorothy Hatsukami, PHD
role: PRINCIPAL_INVESTIGATOR
References: