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Evaluating New Nicotine Standards for Cigarettes - Project 3 (CENIC2-P3)

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ClinicalTrials.gov Identifier: NCT03194256
Recruitment Status : Recruiting
First Posted : June 21, 2017
Last Update Posted : April 5, 2019
Sponsor:
Collaborators:
Wake Forest University
University of Minnesota
Information provided by (Responsible Party):
Suzanne M. Colby, Brown University

Brief Summary:
This study is designed to examine how the nicotine content of cigarettes and the nicotine concentration and flavors in e-liquids influence responses to and use of these products in adolescent smokers. Participants will complete a total of six sessions (an in-person screening/baseline session and five lab sessions.

Condition or disease Intervention/treatment Phase
Smoking, Cigarette Electronic Cigarettes Behavioral: Spectrum Research Cigarettes Not Applicable

Detailed Description:

Adolescence is a critical developmental period for tobacco initiation and progression to regular use and dependence. The Food and Drug Administration (FDA) has the authority to establish standards for tobacco products for the protection of public health, including the authority to mandate a reduction in the nicotine content of all cigarettes to minimally addictive levels. Numerous studies have found that adult smokers who are switched to very low nicotine content (VLNC) cigarettes experience reductions in smoking rates, nicotine intake, nicotine dependence and abstinence-induced craving relative to those who use normal nicotine content (NNC) cigarettes. However, studies of VLNC cigarettes in adolescent smokers are limited and more information is needed to inform potential product standards. Furthermore, use of electronic nicotine delivery systems (ENDS), e-cigarettes or vaping devices, has increased dramatically in adolescents. Therefore, effects of VLNC cigarettes on smoking in youth should be examined in the context of vaping device availability. This study is designed to examine how the nicotine content of cigarettes and the nicotine concentration and flavors in e-liquids influence responses to these products in adolescents.

Participants will complete an in-person baseline session in which eligibility criteria are confirmed and background questionnaires are completed. Next, participants will complete five in-person lab sessions in which NNC or VLNC cigarettes are available (based on random assignment). During the first lab session, participants will test the assigned research cigarettes when no alternative product is available. During each of the four remaining lab sessions, smokers' responses to the assigned research cigarettes will be compared to their responses to a vaping device with the following characteristics: 1) no nicotine, tobacco flavor; 2) no nicotine, non-tobacco flavor; 3) moderate nicotine concentration, tobacco flavor; or 4) moderate nicotine concentration, non-tobacco flavor. In each session, after sampling and rating the subjective effects of the products available during that session, participants will make a series of 10 choices. Choices will be for either 2 puffs of the research cigarette, 2 puffs of the vaping device, or abstinence from puffing.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Mixed between subjects and within-subjects design. Random assignment to the between subjects factor (nicotine content in cigarettes), within-subjects manipulation of nicotine concentration and flavors in e-liquid in the electronic cigarettes
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Participants will be blind to the nicotine content of their assigned study cigarette and the nicotine dose of the e-liquid in the study vaping device. Investigators, research staff, and biostatisticians will also be blind to the conditions. E-liquid flavors will not be blinded.
Primary Purpose: Other
Official Title: Effects of Very Low Nicotine Content Cigarettes and E-cigarette Characteristics on Smoking in Adolescents
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : February 28, 2022
Estimated Study Completion Date : February 28, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: E-Cigarettes

Arm Intervention/treatment
Active Comparator: Normal Nicotine Content Cigarettes
Spectrum Research Cigarettes: 15.8 mg nicotine/g tobacco, 9 mg of tar
Behavioral: Spectrum Research Cigarettes
Participants will be assigned to either normal nicotine content cigarettes or very low nicotine content cigarettes.

Experimental: Very Low Nicotine Content Cigarettes
Spectrum Research Cigarettes: 0.4 mg nicotine/g tobacco, 9 mg of tar
Behavioral: Spectrum Research Cigarettes
Participants will be assigned to either normal nicotine content cigarettes or very low nicotine content cigarettes.




Primary Outcome Measures :
  1. Number of cigarette puffs taken (0 to 20) [ Time Frame: 30-minute preference task at each of the 5 laboratory sessions ]
    The number of cigarette puffs selected during a 30 minute choice procedure, as a function of availability (yes/no) and characteristics (nicotine concentration; flavors) of a vaping device.


Secondary Outcome Measures :
  1. Number of e-cig puffs taken (0 to 20) [ Time Frame: 30-minute preference task session in sessions 2 to 5 ]
    The number of cigarette puffs selected during a 30 minute choice procedure, as a function of availability (yes/no) and characteristics (nicotine concentration; flavors) of a vaping device.

  2. CO boost [ Time Frame: 30-minute preference task at each of the 5 laboratory sessions ]
    Post-choice CO minus pre-choice CO


Other Outcome Measures:
  1. Number of choices for cigarette puffs [ Time Frame: 30-minute preference task at each of the 5 laboratory sessions ]
    0 to 10

  2. Number of choices for e-cig puffs [ Time Frame: 30-minute preference task at each of the 5 laboratory sessions ]
    0 to 10

  3. Number of choices to abstain from puffing [ Time Frame: 30-minute preference task at each of the 5 laboratory sessions ]
    0 to 10

  4. Drop-out rate [ Time Frame: Baseline-Lab Session 5; 2-8 weeks; average 3-4 weeks ]
    Measures of compliance

  5. Minnesota Nicotine Withdrawal Scale (MNWS) [ Time Frame: Baseline-Lab Session 5; 2-8 weeks; average 3-4 weeks ]
    Measures withdrawal symptoms

  6. Questionnaire of Smoking Urges (QSU) [ Time Frame: Baseline-Lab Session 5; 2-8 weeks; average 3-4 weeks ]
    Measures craving

  7. Positive and Negative Affect Scale (PANAS) [ Time Frame: Baseline-Lab Session 5; 2-8 weeks; average 3-4 weeks ]
    Measures positive and negative affect

  8. Cigarette Evaluation Scale (CES) [ Time Frame: Baseline-Lab Session 5; 2-8 weeks; average 3-4 weeks ]
    Measures subjective responses cigarettes

  9. Cigarette Purchase Task [ Time Frame: Baseline-Lab Session 5; 2-8 weeks; average 3-4 weeks ]
    Measures demand for cigarettes across a range of prices

  10. Perceived Health Risk Scale [ Time Frame: Baseline-Lab Session 5; 2-8 weeks; average 3-4 weeks ]
    Measures perceived risk of cigarettes

  11. Heart rate [ Time Frame: Baseline-Lab Session 5; 2-8 weeks; average 3-4 weeks ]
    Measures of cardiovascular function

  12. Blood pressure [ Time Frame: Baseline-Lab Session 5; 2-8 weeks; average 3-4 weeks ]
    Measures of cardiovascular function

  13. Total Nicotine Equivalents (TNE) [ Time Frame: Baseline; Week 1 ]
    Biomarkers

  14. Nicotine Metabolite Ratio (NMR) [ Time Frame: Baseline; Week 1 ]
    Biomarkers

  15. Cotinine [ Time Frame: Baseline; Week 1 ]
    Biomarkers: measures a metabolite of nicotine

  16. Carbon Monoxide (CO) [ Time Frame: Baseline-Lab Session 5; 2-8 weeks; average 3-4 weeks ]
    Biomarkers: measures expired alveolar carbon monoxide level



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Ages 15-19
  2. Adolescents who report current daily cigarette smoking for at least 3 months
  3. Must have used an electronic nicotine device on a minimum of two lifetime occasions.
  4. Breath Carbon Monoxide (CO) levels > 5 ppm (if < 5 ppm, then cotinine assay via NicAlert Strip = > 3)
  5. Speak, comprehend, and read English well enough to complete study procedures

Exclusion Criteria:

  1. Unwilling to use research cigarettes or ENDS as part of the study
  2. Intention to quit smoking in the next 30 days
  3. Using ENDS > 25 days in the past 30 days
  4. Using tobacco products (other than ENDS or roll-your-own tobacco) > 10 days in the past 30 days.
  5. Any medical or psychiatric condition in which participation is likely to post a significant threat to health or for which the condition could interfere with the ability of the participant to fully participants (as determined by the LMP)
  6. Self-reported illicit use of any drug except marijuana > 10 days in the past 30 days
  7. Binge drinking alcohol (>10 days in the past 30 days, >4/5 drinks in a 2-hour period (female/male))
  8. Pregnant or breastfeeding
  9. CO reading > 80 ppm
  10. Systolic BP outside the range of 90-159, diastolic BP outside the range of 50-99, or heart rate outside the range of 45-104. Participants failing for any of these criteria will be allowed to re-screen once per criterion.
  11. Indicating Yes on Questions 4-6 on the MINI with a suicide attempt in the past 5 years (if within the past 6-10 years, LMP approval required).
  12. Having participated in another research study during the past year in which they were switched to reduced nicotine cigarettes for longer than one week.

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): NCT03194256


Contacts
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Contact: Suzanne Colby, PhD (401) 863-6655 suzanne_colby@brown.edu

Locations
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United States, Rhode Island
Brown University School of Public Health Recruiting
Providence, Rhode Island, United States, 02912
Contact: Christine Goodwin, MS    401-863-6402    christine_goodwin@brown.edu   
Principal Investigator: Suzanne Colby, PhD         
Principal Investigator: Jennifer Tidey, PhD         
Sub-Investigator: Rachel Cassidy, PhD         
Sub-Investigator: Patricia Cioe, PhD         
Sponsors and Collaborators
Brown University
Wake Forest University
University of Minnesota
Investigators
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Principal Investigator: Suzanne Colby, PhD Brown University

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Responsible Party: Suzanne M. Colby, Multi-PI, Brown University
ClinicalTrials.gov Identifier: NCT03194256     History of Changes
Other Study ID Numbers: 1705001771
First Posted: June 21, 2017    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Suzanne M. Colby, Brown University:
Smoking
Cigarettes
E-Cigarettes
Additional relevant MeSH terms:
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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