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Trial record 14 of 19 for:    E-cigarettes youth

Impact of Nicotine Reduction on Adolescent Cigarette Use, Alternative Tobacco Use, and Harm From Tobacco (SIREN)

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. Identifier: NCT03860077
Recruitment Status : Not yet recruiting
First Posted : March 1, 2019
Last Update Posted : March 1, 2019
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Brown University

Brief Summary:
Adolescents are an important vulnerable population to consider as the FDA moves toward a nicotine reduction policy. Such a policy, which would mandate a reduction of nicotine in all commercially available cigarettes, has the potential to transform public health and greatly reduce the toll of tobacco-related death and disease. Yet, data on the effects of such a policy on cigarette use among adolescents are lacking. Further, the advent of e-cigarettes and the popularity of alternative tobacco products have fundamentally altered the current landscape of nicotine delivery, and these products are widely used by adolescents. Although adolescent cigarette use is at an all-time low in the U.S., this reduction has been mirrored by an increase in e-cigarette use, and multiple tobacco product (MTP) use is the most common pattern of use in youth. Adolescent MTP users are more likely to be dependent on nicotine and to have begun using tobacco earlier than their single-product using peers. Thus, MTP-using youth differ from youth who solely smoke cigarettes in meaningful ways that have implications for responses to a nicotine reduction regulatory policy. In adults, longer-term studies have demonstrated that very low nicotine content (VLNC) cigarette exposure results in fewer cigarettes smoked and reduced toxicant exposure; however, increased use of alternative tobacco products has also been reported. No studies to date have examined the effects of VLNC cigarettes on MTP use or toxicant exposure in youth. This study will use real-time, smartphone-based ecological momentary assessment (EMA) and laboratory-based assessments to: (1) investigate the effects of cigarette nicotine reduction on cigarette and MTP use, (2) assess the influence of cigarette nicotine reduction on the harms associated with tobacco use, including nicotine and toxicant exposure, respiratory symptoms, perceived health risk and nicotine dependence, and (3) use a combination of laboratory and real-time assessment to investigate the effects of nicotine reduction on changes in withdrawal, craving, and the reinforcing efficacy of cigarettes to characterize the mechanisms by which VLNC use may affect behavior. Overall, this project will help determine the effects of VLNC cigarettes on real-world tobacco use behavior and indices of tobacco-related harm in adolescents, and examining the mechanisms through which nicotine reduction in cigarettes may effect such changes.

Condition or disease Intervention/treatment Phase
Nicotine Dependence, Cigarettes, Uncomplicated Drug: Very Low Nicotine Content Cigarettes Drug: Normal Nicotine Content Cigarettes Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Basic Science
Official Title: Impact of Nicotine Reduction on Adolescent Cigarette Use, Alternative Tobacco Use, and Harm From Tobacco
Estimated Study Start Date : April 2019
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Very Low Nicotine Content Cigarettes Drug: Very Low Nicotine Content Cigarettes
Very Low Nicotine Content Cigarettes

Active Comparator: Normal Nicotine Content Cigarettes Drug: Normal Nicotine Content Cigarettes
Normal Nicotine Content Cigarettes

Primary Outcome Measures :
  1. Cigarettes smoked per day [ Time Frame: Baseline-Week 4 ]
  2. Total Amount of Alternative Product Use [ Time Frame: Baseline-Week 4 ]

Secondary Outcome Measures :
  1. Amount of combustible and noncombustible alternative product use [ Time Frame: Baseline-Week 4 ]
  2. Number of Study Cigarettes [ Time Frame: Baseline-Week 4 ]
  3. Toxicant Exposure [ Time Frame: Baseline-Week 4 ]
    Total Nicotine Equivalents, cotinine, and/or tobacco-specific carcinogens

  4. Respiratory outcomes [ Time Frame: Baseline-Week 4 ]
    Forced Expiratory Volume (FEV) Outcomes

Other Outcome Measures:
  1. American Thoracic Society Questionnaire [ Time Frame: Baseline-Week 4 ]
    Respiratory Health Symptoms; an 8-item questionnaire measuring frequency of experience respiratory symptoms; scores can range from 8 to 40 and greater scores indicate greater frequency.

  2. Perceived health risk questionnaire [ Time Frame: Baseline-Week 4 ]
    Perceived risk for developing diseases associated with use study cigarettes and usual brand cigarettes; Scores range from 1 (much less risk) to 5 (much greater risk) for each disease

  3. Nicotine dependence [ Time Frame: Baseline-Week 4 ]
    Modified Fagerstrom Tolerance Questionnaire (mFTQ) score; Scale 2-8, higher scores indicate greater nicotine dependence

  4. Craving [ Time Frame: Baseline-Week 4 ]
    Questionnaire on Smoking Urges (QSU) post- smoking in the laboratory, a 10 item scale that is comprised of 2 factors; Factor 1 included items 1, 3, 6, 7, and 10 Factor 2 included items 2, 4, 5, 8, and 9 The score for each factor is calculated by summing the item scores; the total score is calculated by summing all 10 items. A single-item craving question (ranging from 1-10, not all to greatly) from daily random and post-event Ecological Momentary Assessments.

  5. Withdrawal [ Time Frame: Baseline-Week 4 ]
    Minnesota Nicotine Withdrawal Scale 7-item version; greater score indicates greater withdrawal

  6. Subjective Response to Cigarettes [ Time Frame: Baseline-Week 4 ]
    Cigarette Evaluation Scale post-smoking in the laboratory; 5 subscales are derived from this scale: Psychological Reward, Smoking Satisfaction, Enjoyment of Respiratory Sensations, Craving Reduction; Aversion. Event level on satisfaction derived from post-use responses on daily Ecological Momentary Assessments.

  7. Hypothetical Purchasing of Cigarettes [ Time Frame: Baseline-Week 4 ]
    Cigarette Purchase Task; Five indices of demand for cigarettes are derived from this measure (Intensity, Omax, Breakpoint, Pmax, Alpha)

  8. Hypothetical Purchasing of Tobacco Products [ Time Frame: Baseline-Week 4 ]
    Purchasing of cigarettes and other tobacco products across changing prices in Experimental Tobacco Marketplace task

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.

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

Inclusion Criteria:

  • 1) Ages 15-19 inclusive 2) Male and female current daily smokers

    1. Defined as self-reported daily cigarette smoking at phone screening AND
    2. a breath carbon monoxide (CO) criterion of 5 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) 3) Current users of alternative tobacco product(s)

    a. Defined as any self-reported use of at least one non-cigarette tobacco product (e.g., e-cigarettes, little cigars, cigarillos, hookah, etc.) in the past 30 days 4) Participants must speak and comprehend English well enough to complete study procedures.

    a. Participant will be asked to read aloud first few lines of informed consent and then summarize the contents aloud to check for competency 5) Participants under 18 must provide assent and parental consent from a parent/guardian.

    a. Participants age 18 or 19 may provide their own written consent contingent on photo ID verification of age.

Exclusion Criteria:

  • 1) Unwilling to use research cigarettes as part of the study 2) Self-reported binge drinking of alcohol (> 4/5 drinks within a 2-hour period for female/male participants respectively) or use of illicit or non-prescribed drugs (excluding marijuana) > 10 days in the past 30 days

    a. We will ask about daily alcohol and drug use in the phone screen, and we will use the Timeline Follow-Back to assess current and recent marijuana and alcohol use.

    3) Currently seeking treatment to quit smoking, and/or intending to quit smoking for good in the next 30 days

    1. This information corresponds to questions 2 & 3 of the Stages of Change measure which will be administered at the in-person screening.
    2. These participants will be excluded, and provided with referral information for cessation services in the community.

      4) Suicidal ideation in the past month or any past-year suicide attempts

    a. Suicidal ideation determined by the MINI ( Mini International Neuropsychiatric Interview) suicide subscale at the in-person screening (Questions 4 and 5) b. Suicide attempt in the past year determined by MINI question 6.a. (If participant has a lifetime history of suicide attempt between 1 and 10 years ago, licensed medical monitor approval required) c. If a participant indicates that he/she currently has suicidal ideation during this or any future session, the Emergency Protocol will be followed in which a Licensed Clinician will be contacted immediately, and participants will speak with the clinician over the phone and the clinician will determine the appropriate action to take to keep the child safe.

    5) Pregnant or breastfeeding

    a. Determined by urine test at in-person screening; tested again at each in-person visit; participant will be excluded or withdrawn if test indicates pregnancy b. Self-reports current breastfeeding at in-person screening 6) Any medical or psychiatric conditions in which participation is likely to pose a significant threat to health or for which the condition could interfere with the ability of the participant to fully participate (as determined by LMP).

    7) Having participated in another research study during the past year in which they were switched to research 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 identifier (NCT number): NCT03860077

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Contact: Rachel Cassidy, PhD 4018636621
Contact: Suzanne Colby, PhD 4018636655

Sponsors and Collaborators
Brown University
National Institute on Drug Abuse (NIDA)
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Principal Investigator: Rachel Cassidy, PhD Brown University

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Responsible Party: Brown University Identifier: NCT03860077     History of Changes
Other Study ID Numbers: R01DA047356 ( U.S. NIH Grant/Contract )
1R01DA047356-01 ( U.S. NIH Grant/Contract )
First Posted: March 1, 2019    Key Record Dates
Last Update Posted: March 1, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: The investigators involved in this project intend to share findings from its research through publications and presentations. After all data have been collected and the results of the study have been published, de-identified data will be made available to other qualified investigators upon request. Institutions and/or individuals wishing to access any resources or data must contact the Principal Investigators. Persons requesting data must do so in writing, identifying their affiliation and how and by whom the data will be used. The request will be evaluated by the PIs and Co-Investigators to ensure that it meets reasonable demands of scientific integrity.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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