Evaluation of Very Low Nicotine Content Cigarettes in Adolescent Smokers

NCT02587312 | Completed

• 1 other identifier: 1K01CA189300
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Number of cigarettes smoked per day

  End of 3-week intervention

Study Arms (2)

Normal Nicotine Content Cigarettes

ACTIVE COMPARATOR

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

Other: Standard nicotine content cigarettes

Very Low Nicotine Content Cigarettes

EXPERIMENTAL

SPECTRUM cigarette: 0.03 mg nicotine with 9 mg tar

Other: Very low nicotine content cigarettes

Interventions

Very low nicotine content cigarettes OTHER

Very Low Nicotine Content Cigarettes

Standard nicotine content cigarettes OTHER

Normal Nicotine Content Cigarettes

Eligibility Criteria

• Age: 15 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Brown University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Brown University School of Public Health

Providence, Rhode Island, 02912, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 23, 2015
• First Posted: October 27, 2015
• Study Start: October 13, 2016
• Primary Completion: August 28, 2019
• Study Completion: August 31, 2019
• Last Updated: October 27, 2022

Record last verified: 2022-10

Locations

US (1)