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Evaluation of Very Low Nicotine Content Cigarettes in Adolescent Smokers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02587312
Recruitment Status : Completed
First Posted : October 27, 2015
Last Update Posted : January 18, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Rachel N Cassidy, Brown University

Study Description
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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
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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

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Arms and Interventions
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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
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Primary Outcome Measures :
  1. Number of cigarettes smoked per day [ Time Frame: End of 3-week intervention ]

Eligibility Criteria
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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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02587312


Locations
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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
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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    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Additional relevant MeSH terms:
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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