Evaluation of Very Low Nicotine Content Cigarettes in Adolescent Smokers

• ClinicalTrials.gov Identifier: NCT02587312
• Recruitment Status: Completed
• First Posted: October 27, 2015
• Last Update Posted: January 18, 2020
• Sponsor: Brown University
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): Rachel N Cassidy, Brown University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Nicotine Dependence	Other: Very low nicotine content cigarettes; Other: Standard nicotine content cigarettes	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: Evaluation of Very Low Nicotine Content Cigarettes in Adolescent Smokers
• Actual Study Start Date: October 13, 2016
• Actual Primary Completion Date: August 28, 2019
• Actual Study Completion Date: August 31, 2019

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 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)	Other: Standard nicotine content cigarettes
Experimental: Very Low Nicotine Content Cigarettes; SPECTRUM cigarette: 0.03 mg nicotine with 9 mg tar	Other: Very low nicotine content cigarettes

Outcome Measures

Primary Outcome Measures :

1. Number of cigarettes smoked per day [ Time Frame: End of 3-week intervention ]

Eligibility Criteria

• Ages Eligible for Study: 15 Years to 19 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Rhode Island

Brown University School of Public Health

Providence, Rhode Island, United States, 02912

Sponsors and Collaborators

Brown University

National Cancer Institute (NCI)

More Information

• Responsible Party: Rachel N Cassidy, Assistant Professor, Brown University
• ClinicalTrials.gov Identifier: NCT02587312
• Other Study ID Numbers: 1K01CA189300 ( U.S. NIH Grant/Contract )
• First Posted: October 27, 2015
• Last Update Posted: January 18, 2020
• Last Verified: January 2020

Additional relevant MeSH terms:

Tobacco Use Disorder; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Nicotine; Ganglionic Stimulants; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Nicotinic Agonists; Cholinergic Agonists; Cholinergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action