Impact of Very Low Nicotine Content Cigarettes in a Complex Marketplace

University of Minnesota (UMN)

Status and phase: Completed; Phase 3

Conditions: Nicotine Dependence; Tobacco Smoking

Treatments: Drug: Very Low Nicotine Content Cigarettes; Drug: Normal Nicotine Content Cigarettes

Study type: Interventional

Funder types: Other

Identifiers

NCT03272685

2017NTLS107

Details and patient eligibility

About

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.

Full 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).

Enrollment: 799 patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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799 participants in 2 patient groups

Very Low Nicotine Content Cigarettes

Experimental group

Description:

Very Low Nicotine Content Cigarettes (0.4 mg nicotine/g tobacco; 9 mg of tar): Median nicotine content, averaged across menthol and non-menthol cigarettes:

Treatment:

Drug: Very Low Nicotine Content Cigarettes

Normal Nicotine Content Cigarettes

Active Comparator group

Description:

Normal (Conventional) Nicotine Content (15.8 mg nicotine/g tobacco; 9 mg of tar): Median nicotine content, averaged across menthol and non-menthol cigarettes

Treatment:

Drug: Normal Nicotine Content Cigarettes