Evaluating New Nicotine Standards for Cigarettes - Project 3

NCT ID: NCT03194256

Last Updated: 2023-12-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-01
• Study Completion Date: 2022-11-30

Brief Summary

This study is designed to examine how the nicotine content of cigarettes and the nicotine concentration and flavors in e-liquids influence responses to and use of these products in adolescent smokers. Participants will complete a total of six sessions (an in-person screening/baseline session and five lab sessions.

Detailed Description

Adolescence is a critical developmental period for tobacco initiation and progression to regular use and dependence. The Food and Drug Administration (FDA) has the authority to establish standards for tobacco products for the protection of public health, including the authority to mandate a reduction in the nicotine content of all cigarettes to minimally addictive levels. Numerous studies have found that adult smokers who are switched to very low nicotine content (VLNC) cigarettes experience reductions in smoking rates, nicotine intake, nicotine dependence and abstinence-induced craving relative to those who use normal nicotine content (NNC) cigarettes. However, studies of VLNC cigarettes in adolescent smokers are limited and more information is needed to inform potential product standards. Furthermore, use of electronic nicotine delivery systems (ENDS), e-cigarettes or vaping devices, has increased dramatically in adolescents. Therefore, effects of VLNC cigarettes on smoking in youth should be examined in the context of vaping device availability. This study is designed to examine how the nicotine content of cigarettes and the nicotine concentration and flavors in e-liquids influence responses to these products in adolescents.

Participants will complete an in-person baseline session in which eligibility criteria are confirmed and background questionnaires are completed. Next, participants will complete five in-person lab sessions in which NNC or VLNC cigarettes are available (based on random assignment). During the first lab session, participants will test the assigned research cigarettes when no alternative product is available. During each of the four remaining lab sessions, smokers' responses to the assigned research cigarettes will be compared to their responses to a vaping device with the following characteristics: 1) no nicotine, tobacco flavor; 2) no nicotine, non-tobacco flavor; 3) moderate nicotine concentration, tobacco flavor; or 4) moderate nicotine concentration, non-tobacco flavor. In each session, after sampling and rating the subjective effects of the products available during that session, participants will make a series of 10 choices. Choices will be for either 2 puffs of the research cigarette, 2 puffs of the vaping device, or abstinence from puffing.

Conditions

Smoking, Cigarette; Electronic Cigarettes

Keywords

Smoking; Cigarettes; E-Cigarettes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Normal Nicotine Content Cigarettes

Spectrum Research Cigarettes: 15.8 mg nicotine/g tobacco, 9 mg of tar

Group Type: ACTIVE_COMPARATOR

Spectrum Research Cigarettes

Intervention Type: BEHAVIORAL

Participants will be assigned to either normal nicotine content cigarettes or very low nicotine content cigarettes.

Very Low Nicotine Content Cigarettes

Spectrum Research Cigarettes: 0.4 mg nicotine/g tobacco, 9 mg of tar

Group Type: EXPERIMENTAL

Spectrum Research Cigarettes

Intervention Type: BEHAVIORAL

Participants will be assigned to either normal nicotine content cigarettes or very low nicotine content cigarettes.

Interventions

Spectrum Research Cigarettes

Participants will be assigned to either normal nicotine content cigarettes or very low nicotine content cigarettes.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Ages 15-20

2. Adolescents who report current daily or near daily cigarette smoking for at least 3 months

3. Must have used an electronic nicotine device on a minimum of two lifetime occasions.

4. Breath Carbon Monoxide (CO) levels > 5 ppm (if < 5 ppm, then cotinine assay via NicAlert Strip = > 3)

5. Speak, comprehend, and read English well enough to complete study procedures

Exclusion Criteria

1. Unwilling to use research cigarettes or ENDS as part of the study

2. Intention to quit smoking in the next 30 days

3. Using tobacco products (other than ENDS or roll-your-own tobacco) > 15 days in the past 30 days.

4. Any medical or psychiatric condition in which participation is likely to post a significant threat to health or for which the condition could interfere with the ability of the participant to fully participants (as determined by the LMP)

5. Self-reported illicit use of any drug except marijuana > 10 days in the past 30 days

6. Binge drinking alcohol (>10 days in the past 30 days, >4/5 drinks in a 2-hour period (female/male))

7. Pregnant or breastfeeding

8. CO reading > 80 ppm

9. Systolic BP outside the range of 90-159, diastolic BP outside the range of 50-99, or heart rate outside the range of 45-104. Participants failing for any of these criteria will be allowed to re-screen once per criterion.

10. Indicating Yes on Questions 4-6 on the MINI with a suicide attempt in the past 2 years (if within the past 2-10 years, LMP approval required).

11. Having participated in another research study during the past year in which they were switched to reduced nicotine cigarettes for longer than one week.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Wake Forest University

OTHER

Sponsor Role: collaborator

University of Minnesota

OTHER

Sponsor Role: collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Food and Drug Administration (FDA)

FED

Sponsor Role: collaborator

Brown University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Suzanne Colby, PhD

Role: PRINCIPAL_INVESTIGATOR

Brown University

Jennifer Tidey, PhD

Role: PRINCIPAL_INVESTIGATOR

Brown University

Locations

Brown University School of Public Health

Providence, Rhode Island, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

U54DA031659

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1705001771

Identifier Type: -

Identifier Source: org_study_id