Evaluation of Very Low Nicotine Content Cigarettes in Adolescent Smokers

NCT ID: NCT02587312

Last Updated: 2022-10-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-13
• Study Completion Date: 2019-08-31

Brief Summary

The purpose of this study is to determine how reducing the level of nicotine in cigarettes may affect adolescent smoking behavior. In this study, the researchers will randomize adolescent (age 15-19) daily smokers to either receive VLNC cigarettes or normal-nicotine content (NNC) study cigarettes for three weeks following a one-week usual-brand baseline period. Participants will be instructed to smoke only those cigarettes. The researchers will conduct daily assessments of total cigarette use (both study cigarette and non-compliant use of usual brand cigarettes), craving, and withdrawal, weekly assessments of breath carbon monoxide (CO) levels, cigarette acceptability, risk perceptions of VLNC and NNC cigarettes and demand for usual-brand cigarettes, and pre- vs. post-use measures of nicotine and toxicant exposure. Overall, the project will help determine how VLNC cigarettes may affect real-world smoking behavior in adolescents, and illuminate the potential mechanisms through which these products may effect such changes. Such knowledge will contribute to the science base that may inform future policy decisions.

Conditions

Nicotine Dependence

Study Design

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

Study Groups

Normal Nicotine Content Cigarettes

SPECTRUM cigarette: 0.8 mg nicotine with 10.5 mg tar (standard nicotine and tar yields of commercially available cigarettes; control condition)

Group Type: ACTIVE_COMPARATOR

Standard nicotine content cigarettes

Intervention Type: OTHER

Very Low Nicotine Content Cigarettes

SPECTRUM cigarette: 0.03 mg nicotine with 9 mg tar

Group Type: EXPERIMENTAL

Very low nicotine content cigarettes

Intervention Type: OTHER

Interventions

Very low nicotine content cigarettes

Intervention Type: OTHER

Standard nicotine content cigarettes

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• current daily smoking (1 or more cigarettes per day for the past 6 months or longer). Participants must meet a breath carbon monoxide criterion of 6 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).
• Participants must speak and comprehend English well enough to complete study procedures.

Exclusion Criteria

• Current pregnancy
• Self-reported daily use of alcohol or other non-prescribed drugs (excluding marijuana).
• Participants who are seeking treatment for their smoking or who report that they intend to quit smoking within the next 30 days and have made a 24-hour quit attempt in the past year
• Participants who report current suicidal ideation on the MINI suicide subscale questions 4 & 5 ("In the past month did you have a suicide plan?" and "In the past month did you attempt suicide?"), as well as participants who indicate that they have made a suicide attempt in their lifetime
• Participants who report use of other non-cigarette tobacco products more than 9 out of the last 30 days

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Brown University

OTHER

Sponsor Role: lead

Responsible Party

Rachel N Cassidy

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Brown University School of Public Health

Providence, Rhode Island, United States

Countries

United States

Other Identifiers

1K01CA189300

Identifier Type: NIH

Identifier Source: org_study_id

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