Impact of Very Low Nicotine Content Cigarettes in a Complex Marketplace

NCT ID: NCT03272685

Last Updated: 2024-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 799 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-01
• Study Completion Date: 2023-01-10

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).

Conditions

Tobacco Smoking; Nicotine Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Very Low Nicotine Content Cigarettes

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:

Group Type: EXPERIMENTAL

Very Low Nicotine Content Cigarettes

Intervention Type: DRUG

0.4 mg nicotine/g tobacco; 9 mg tar

Normal Nicotine Content Cigarettes

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

Group Type: ACTIVE_COMPARATOR

Normal Nicotine Content Cigarettes

Intervention Type: DRUG

15.8 mg nicotine/g tobacco; 9 mg tar

Interventions

Very Low Nicotine Content Cigarettes

0.4 mg nicotine/g tobacco; 9 mg tar

Intervention Type: DRUG

Normal Nicotine Content Cigarettes

15.8 mg nicotine/g tobacco; 9 mg tar

Intervention Type: DRUG

Other Intervention Names

Reduced Nicotine Content Cigarettes; Conventional Nicotine Content Cigarettes

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Duke University

OTHER

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: collaborator

Wake Forest University

OTHER

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: collaborator

Brown University

OTHER

Sponsor Role: collaborator

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dorothy Hatsukami, PHD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

Tobacco Research Center

San Francisco, California, United States

Tobacco Research Programs

Minneapolis, Minnesota, United States

The Center for Addiction Science and Technology

Durham, North Carolina, United States

Wake Forest Tobacco Control Center of Excellence

Winston-Salem, North Carolina, United States

Center for Interdisciplinary Research on Nicotine Addiction

Philadelphia, Pennsylvania, United States

Brown University Center for Alcohol and Addiction Studies School of Public Health

Providence, Rhode Island, United States

Countries

United States

References

Said RJ, Carroll DM, Luo X, Hu J, Cao Q, Tessier KM, Bittencourt L, Hatsukami DK; Center for Evaluation of Nicotine in Cigarettes (CENIC). Secondary analysis of a randomized clinical trial of very low nicotine cigarettes: Outcomes across social and demographic groups. Prev Med. 2025 Jul 21:108362. doi: 10.1016/j.ypmed.2025.108362. Online ahead of print.

Reference Type: DERIVED

PMID: 40701191 (View on PubMed)

Hatsukami DK, Jensen JA, Carroll DM, Luo X, Strayer LG, Cao Q, Hecht SS, Murphy SE, Carmella SG, Denlinger-Apte RL, Colby S, Strasser AA, McClernon FJ, Tidey J, Benowitz NL, Donny EC. Reduced nicotine in cigarettes in a marketplace with alternative nicotine systems: randomized clinical trial. Lancet Reg Health Am. 2024 Jun 3;35:100796. doi: 10.1016/j.lana.2024.100796. eCollection 2024 Jul.

Reference Type: DERIVED

PMID: 38911348 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

2017NTLS107

Identifier Type: -

Identifier Source: org_study_id