Impact of Nicotine Reduction on Adolescent Cigarette Use, Alternative Tobacco Use, and Harm From Tobacco

NCT ID: NCT03860077

Last Updated: 2023-12-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-10
• Study Completion Date: 2022-03-23

Brief Summary

Adolescents are an important vulnerable population to consider as the FDA moves toward a nicotine reduction policy. Such a policy, which would mandate a reduction of nicotine in all commercially available cigarettes, has the potential to transform public health and greatly reduce the toll of tobacco-related death and disease. Yet, data on the effects of such a policy on cigarette use among adolescents are lacking. Further, the advent of e-cigarettes and the popularity of alternative tobacco products have fundamentally altered the current landscape of nicotine delivery, and these products are widely used by adolescents. Although adolescent cigarette use is at an all-time low in the U.S., this reduction has been mirrored by an increase in e-cigarette use, and multiple tobacco product (MTP) use is the most common pattern of use in youth. Adolescent MTP users are more likely to be dependent on nicotine and to have begun using tobacco earlier than their single-product using peers. Thus, MTP-using youth differ from youth who solely smoke cigarettes in meaningful ways that have implications for responses to a nicotine reduction regulatory policy. In adults, longer-term studies have demonstrated that very low nicotine content (VLNC) cigarette exposure results in fewer cigarettes smoked and reduced toxicant exposure; however, increased use of alternative tobacco products has also been reported. No studies to date have examined the effects of VLNC cigarettes on MTP use or toxicant exposure in youth. This study will use real-time, smartphone-based ecological momentary assessment (EMA) and laboratory-based assessments to: (1) investigate the effects of cigarette nicotine reduction on cigarette and MTP use, (2) assess the influence of cigarette nicotine reduction on the harms associated with tobacco use, including nicotine and toxicant exposure, respiratory symptoms, perceived health risk and nicotine dependence, and (3) use a combination of laboratory and real-time assessment to investigate the effects of nicotine reduction on changes in withdrawal, craving, and the reinforcing efficacy of cigarettes to characterize the mechanisms by which VLNC use may affect behavior. Overall, this project will help determine the effects of VLNC cigarettes on real-world tobacco use behavior and indices of tobacco-related harm in adolescents, and examining the mechanisms through which nicotine reduction in cigarettes may effect such changes.

Conditions

Nicotine Dependence, Cigarettes, Uncomplicated

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Very Low Nicotine Content Cigarettes

Group Type: EXPERIMENTAL

Very Low Nicotine Content Cigarettes

Intervention Type: DRUG

Very Low Nicotine Content Cigarettes

Normal Nicotine Content Cigarettes

Group Type: ACTIVE_COMPARATOR

Normal Nicotine Content Cigarettes

Intervention Type: DRUG

Normal Nicotine Content Cigarettes

Interventions

Very Low Nicotine Content Cigarettes

Very Low Nicotine Content Cigarettes

Intervention Type: DRUG

Normal Nicotine Content Cigarettes

Normal Nicotine Content Cigarettes

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 1) Ages 15-20 inclusive 2) Male and female current daily smokers

1. Defined as self-reported daily cigarette smoking at phone screening AND

2. a breath carbon monoxide (CO) criterion of 5 ppm or higher; if this is not met, urine cotinine levels, detected by a NicAlert cotinine screening device, must indicate recent smoking (level 3 or higher) 3) Current users of alternative tobacco product(s)

a. Defined as any self-reported use of at least one non-cigarette tobacco product (e.g., e-cigarettes, little cigars, cigarillos, hookah, etc.) in the past 30 days 4) Participants must speak and comprehend English well enough to complete study procedures.

a. Participant will be asked to read aloud first few lines of informed consent and then summarize the contents aloud to check for competency 5) Participants under 18 must provide assent and parental consent from a parent/guardian.

a. Participants age 18 or 19 may provide their own written consent contingent on photo ID verification of age.

Exclusion Criteria

• 1) Unwilling to use research cigarettes as part of the study 2) Self-reported daily drinking of alcohol or use of illicit or non-prescribed drugs (excluding marijuana) > 10 days in the past 30 days

a. We will ask about daily alcohol and drug use in the phone screen, and we will use the Timeline Follow-Back to assess current and recent marijuana and alcohol use.

3) Currently seeking treatment to quit smoking, and/or intending to quit smoking for good in the next 30 days

1. This information corresponds to questions 2 & 3 of the Stages of Change measure which will be administered at the in-person screening.

2. These participants will be excluded, and provided with referral information for cessation services in the community.

4) Suicidal ideation in the past month or any past-year suicide attempts

a. Suicidal ideation determined by the MINI ( Mini International Neuropsychiatric Interview) suicide subscale at the in-person screening (Questions 4 and 5) b. Suicide attempt in the past year determined by MINI question 6.a. (If participant has a lifetime history of suicide attempt between 1 and 10 years ago, licensed medical monitor approval required) c. If a participant indicates that he/she currently has suicidal ideation during this or any future session, the Emergency Protocol will be followed in which a Licensed Clinician will be contacted immediately, and participants will speak with the clinician over the phone and the clinician will determine the appropriate action to take to keep the child safe.

5) Pregnant or breastfeeding

a. Determined by urine test at in-person screening; tested again at each in-person visit; participant will be excluded or withdrawn if test indicates pregnancy b. Self-reports current breastfeeding at in-person screening 6) Any medical or psychiatric conditions in which participation is likely to pose a significant threat to health or for which the condition could interfere with the ability of the participant to fully participate (as determined by LMP).

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

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

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Brown University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rachel Cassidy, 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

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Document Type: Statistical Analysis Plan

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Document Type: Informed Consent Form: 18+ Consent

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Document Type: Informed Consent Form: Parental Consent Form

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Document Type: Informed Consent Form: Minor Assent Form

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Other Identifiers

1R01DA047356-01

Identifier Type: NIH

Identifier Source: secondary_id

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R01DA047356

Identifier Type: NIH

Identifier Source: org_study_id

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