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Evaluation of Very Low Nicotine Content Cigarettes in Adolescent Smokers

This study is currently recruiting participants.
Verified January 2017 by Rachel N Cassidy, Brown University
Sponsor:
ClinicalTrials.gov Identifier:
NCT02587312
First Posted: October 27, 2015
Last Update Posted: February 1, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Rachel N Cassidy, Brown University
  Purpose
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 Intervention
Nicotine Dependence Other: Very low nicotine content cigarettes Other: Standard nicotine content cigarettes

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Rachel N Cassidy, Brown University:

Primary Outcome Measures:
  • Number of cigarettes smoked per day [ Time Frame: End of 3-week intervention ]

Estimated Enrollment: 90
Actual Study Start Date: November 2016
Estimated Study Completion Date: May 2019
Estimated Primary Completion Date: May 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
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


Contacts
Contact: Rachel N Cassidy, Ph.D (401)863-6621 Rachel_cassidy@brown.edu

Locations
United States, Rhode Island
Brown University School of Public Health Recruiting
Providence, Rhode Island, United States, 02912
Contact: Rachel Cassidy, PhD    401-863-6621    rachel_cassidy@brown.edu   
Sponsors and Collaborators
Brown University
National Cancer Institute (NCI)
  More Information

Responsible Party: Rachel N Cassidy, Assistant Professor, Brown University
ClinicalTrials.gov Identifier: NCT02587312     History of Changes
Other Study ID Numbers: 1K01CA189300 ( U.S. NIH Grant/Contract )
First Submitted: October 23, 2015
First Posted: October 27, 2015
Last Update Posted: February 1, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Nicotine
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
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