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Trial record 10 of 10 for:    anatabine

REN-Project 2 Cigarette and E-cigarette Nicotine Content and E-liquid Flavors

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ClinicalTrials.gov Identifier: NCT03185546
Recruitment Status : Recruiting
First Posted : June 14, 2017
Last Update Posted : January 11, 2019
Sponsor:
Collaborators:
University of Pennsylvania
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Brief Summary:
Project 2 will evaluate the impact of very low nicotine content cigarettes, e-cigarette nicotine content, and e-cigarette flavoring on cigarettes smoked per day, nicotine exposure, puff topography, discomfort/dysfunction, other health-related behaviors, nicotine/tobacco dependence, biomarkers of tobacco exposure, intention to quit, compensatory smoking, other tobacco use, cardiovascular function, and perceived risk. Project 2 will also evaluate differences between conditions in compliance with product use and the ability to abstain from cigarette smoking when provided a financial incentive for abstinence from combusted tobacco. This is not a treatment program for smoking.

Condition or disease Intervention/treatment Phase
Smoking Other: NNC Spectrum Cigarette Other: VLNC Spectrum Cigarette Other: Moderate nicotine level e-liquid Other: Low nicotine level e-liquid Other: Tobacco Flavors Other: Tobacco and non-tobacco e-liquid flavors Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 480 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Project 2: The Impact of Cigarette Nicotine Content, E-cigarette Nicotine Content, and E-cigarette Flavoring on Smoking Behavior
Actual Study Start Date : August 6, 2018
Estimated Primary Completion Date : August 30, 2021
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: E-Cigarettes Smoking

Arm Intervention/treatment
Experimental: NNC cigarette + moderate nicotine e-liquid + tobacco flavors
Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors.
Other: NNC Spectrum Cigarette
Participants are provided with normal nicotine content Spectrum Cigarette for 13 weeks.

Other: Moderate nicotine level e-liquid
Participants are provided with moderate nicotine level e-liquid for 13 weeks

Other: Tobacco Flavors
Participants can choose e-liquid flavors from a selection of tobacco flavors

Experimental: NNC cigarette + low nicotine e-liquid + tobacco flavors
Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with very low nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors.
Other: NNC Spectrum Cigarette
Participants are provided with normal nicotine content Spectrum Cigarette for 13 weeks.

Other: Low nicotine level e-liquid
Participants are provided with very low or nicotine-free nicotine level e-liquid for 13 weeks

Other: Tobacco Flavors
Participants can choose e-liquid flavors from a selection of tobacco flavors

Experimental: NNC cigarette + moderate nicotine e-liquid + variety flavors
Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors.
Other: NNC Spectrum Cigarette
Participants are provided with normal nicotine content Spectrum Cigarette for 13 weeks.

Other: Moderate nicotine level e-liquid
Participants are provided with moderate nicotine level e-liquid for 13 weeks

Other: Tobacco and non-tobacco e-liquid flavors
Participants can choose e-liquid flavors from a selection of flavors that includes tobacco and non-tobacco choices

Experimental: NNC cigarette + low nicotine e-liquid + variety flavors
Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with very low or nicotine-free nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors
Other: NNC Spectrum Cigarette
Participants are provided with normal nicotine content Spectrum Cigarette for 13 weeks.

Other: Low nicotine level e-liquid
Participants are provided with very low or nicotine-free nicotine level e-liquid for 13 weeks

Other: Tobacco and non-tobacco e-liquid flavors
Participants can choose e-liquid flavors from a selection of flavors that includes tobacco and non-tobacco choices

Experimental: VLNC cigarette + moderate nicotine e-liquid + tobacco flavor
Participants are provided with very low nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors.
Other: VLNC Spectrum Cigarette
Participants are provided with very low nicotine content Spectrum Cigarette for13 weeks

Other: Moderate nicotine level e-liquid
Participants are provided with moderate nicotine level e-liquid for 13 weeks

Other: Tobacco Flavors
Participants can choose e-liquid flavors from a selection of tobacco flavors

Experimental: VLNC cigarette + low nicotine e-liquid +tobacco flavors
Participants are provided with very low nicotine content tobacco Spectrum Cigarettes along with very low or nicotine-free nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors.
Other: VLNC Spectrum Cigarette
Participants are provided with very low nicotine content Spectrum Cigarette for13 weeks

Other: Low nicotine level e-liquid
Participants are provided with very low or nicotine-free nicotine level e-liquid for 13 weeks

Other: Tobacco Flavors
Participants can choose e-liquid flavors from a selection of tobacco flavors

Experimental: VLNC cigarette + moderate nicotine e-liquid + variety flavors
Participants are provided with very low nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors.
Other: VLNC Spectrum Cigarette
Participants are provided with very low nicotine content Spectrum Cigarette for13 weeks

Other: Moderate nicotine level e-liquid
Participants are provided with moderate nicotine level e-liquid for 13 weeks

Other: Tobacco and non-tobacco e-liquid flavors
Participants can choose e-liquid flavors from a selection of flavors that includes tobacco and non-tobacco choices

Experimental: VLNC cigarette + low nicotine e-liquid + variety flavors
Participants are provided with very low or nicotine-free nicotine content tobacco Spectrum Cigarettes along with very low nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors
Other: VLNC Spectrum Cigarette
Participants are provided with very low nicotine content Spectrum Cigarette for13 weeks

Other: Low nicotine level e-liquid
Participants are provided with very low or nicotine-free nicotine level e-liquid for 13 weeks

Other: Tobacco and non-tobacco e-liquid flavors
Participants can choose e-liquid flavors from a selection of flavors that includes tobacco and non-tobacco choices




Primary Outcome Measures :
  1. Cigarettes smoked per day [ Time Frame: Baseline-Week 12 ]
    Total cigarettes smoked per day


Secondary Outcome Measures :
  1. Study cigarettes smoked per day [ Time Frame: Baseline-Week 12 ]
    Study cigarettes smoked per day

  2. Fagerstrom Nicotine Dependence Scale [ Time Frame: Baseline-Week 12 ]
    Dependence Measure

  3. Mercapturic Acids [ Time Frame: Baseline-Week 12 ]
    Measure of toxicant exposure

  4. Cigarette Evaluation Scale [ Time Frame: Baseline-Week 12 ]
    Measure of product subjective effects

  5. IVR Review and Timeline Followback [ Time Frame: Baseline-Week 12 ]
    Measure of smoke free days

  6. IVR Review and Timeline Followback [ Time Frame: Baseline-Week 12 ]
    Measure of number of days using assigned vaping device

  7. Minnesota Nicotine Withdrawal Scale [ Time Frame: Baseline-Week 12 ]
    Measure of discomfort and dysfunction


Other Outcome Measures:
  1. IVR Review and Timeline Followback and E-liquid Accountability [ Time Frame: Baseline-Week 12 ]
    Measure of vaping device use

  2. Number of choices to smoke in preference assessment task [ Time Frame: Week 00 ]
    Measure of relative reinforcement

  3. Purchase Task [ Time Frame: Baseline, Week 12 ]
    Measure of relative reinforcement and substitution

  4. Predicted Behavior Questionnaire [ Time Frame: Week 12 ]
    Measure of hypothetical cigarette and vaping device use

  5. IVR Review and Timeline Followback [ Time Frame: Baseline-Week 12 ]
    Measure of compliance

  6. Drop-out rate [ Time Frame: Baseline-Week 12 ]
    Drop-out rate

  7. Urge to Use Questionnaire [ Time Frame: Baseline-Week 12 ]
    Measure of discomfort and dysfunction

  8. Center for Epidemiologic Studies Depression Scale [ Time Frame: Baseline, Weeks 04, 08, 12 ]
    Measure of discomfort and dysfunction

  9. Breath Alcohol [ Time Frame: Baseline - Week 12 ]
    Alcohol use

  10. Urine Drug Screen [ Time Frame: Baseline, Week 12 ]
    Drug use

  11. Alcohol Use Questionnaire [ Time Frame: Baseline-Week 12 ]
    Alcohol use

  12. Drug Use Questionnaire [ Time Frame: Baseline-Week 12 ]
    Drug use

  13. Weight [ Time Frame: Baseline-Week 12 ]
    Weight

  14. Expired Carbon Monoxide [ Time Frame: Baseline - Week 12 ]
    Measure of cigarette smoke exposure

  15. Urinary Anatabine Biomarker [ Time Frame: Baseline -Week 12 ]
    Measure of cigarette exposure and compliance

  16. Total Nicotine Equivalents [ Time Frame: Baseline - Week 12 ]
    Measure of nicotine exposure

  17. Environmental and Social Influences on Tobacco Use Questionnaire [ Time Frame: Baseline-Week 12 ]
    Measure of smoking and vaping context

  18. Context of Product Use Questionnaire [ Time Frame: Baseline-Week 12 ]
    Measure of smoking and vaping context

  19. Puff topography [ Time Frame: Weeks 01 and 10 ]
    Measure of smoking and vaping topography

  20. 30 day Timeline Followback [ Time Frame: Week 30 ]
    Measure of post intervention tobacco use, alcohol use, and drug use

  21. Vaping Utility Questionnaire [ Time Frame: Baseline, Week 12 ]
    Measure of product expectancy

  22. Smoking and Vaping Expectancy Questionnaires [ Time Frame: Baseline-Week 12 ]
    Measure of product expectancy

  23. Cigarette and Product Evaluation Scale [ Time Frame: Baseline-Week 12 ]
    Measure of product characteristics

  24. Perceived Health Risk Questionnaire [ Time Frame: Baseline-Week 12 ]
    Measure of perceived personal health risk

  25. Penn State Smoking Dependence Questionnaire [ Time Frame: Baseline-Week 12 ]
    Dependence Measure (smoking and vaping)

  26. Primary subscales from brief WISDM [ Time Frame: Baseline-Week 12 ]
    Dependence Measure

  27. PATH Smoking Dependence Questions [ Time Frame: Baseline-Week 12 ]
    Dependence Measure (smoking and vaping)

  28. Stages of Change [ Time Frame: Baseline-Week 12 ]
    Measure of intention to quit

  29. Contemplation Ladder [ Time Frame: Baseline-Week 12 ]
    Measure of intention to quit

  30. Quit attempts [ Time Frame: Baseline-Week 12 ]
    Measure of intention to quit



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:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age 18+
  2. Daily smokers who smoke an average of at least five and 50 or fewer cigarettes per day for the last month.
  3. Must have used a vaping device on 2 or more separate occasions before participating in the trial
  4. Expired breath carbon monoxide (CO) level to assess recent smoking. Carbon monoxide level must be > 10 ppm to confirm regular daily smoking. If CO is <10 ppm, NicAlert strips will be used to assess urinary cotinine quantity to confirm smoking status. A result of 2,000 ng/mL is needed to verify regular daily smoking.
  5. Fulfills need for participants in the required strata (age range)

Exclusion Criteria:

  1. Unwilling to use research cigarettes or a vaping device as part of the trial
  2. Currently trying to quit or intending to quit smoking in the next 60 days
  3. Currently seeking treatment for smoking cessation
  4. A quit attempt in the past 30 days resulting in greater than 3 days of abstinence
  5. Using tobacco products, including nicotine replacement therapies or other pharmacotherapies (other than cigarettes, vaping devices or roll-your-own tobacco) more than 9 days in the past 30 days
  6. Unwilling to smoke machine manufactured cigarettes as part of the trial
  7. Use of vaping devices > 15 days of the last 30
  8. 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
  9. Significant unstable medical conditions (any significant change in a serious medical condition occurring during the past 3 months including cardiovascular disease, COPD, and cancer, as determined by the licensed medical monitor)
  10. Significant unstable psychiatric conditions (any significant change in psychiatric symptoms during the past 3 months as determined by the licensed medical monitor)
  11. Schizophrenia and schizoaffective disorder
  12. Positive toxicology screen for any of the following drugs: cocaine, opiates, methadone, benzodiazepines, barbiturates, amphetamines, methamphetamines, and PCP. Positive test for marijuana only allowed. Failing temperature strip for the sample or unable to provide enough urine sample for the drug screen.

    a. Participants with valid prescriptions for opiates, benzodiazepines, barbiturates, amphetamines or methadone (clinic letter) will not be excluded.

  13. Self-reported illicit use of any drug including marijuana ≥ 10 days in the past month
  14. Breath alcohol level > 0.01 (g/dL), as measured by a breath sample.
  15. Binge drinking alcohol (more than 9 days in the past 30 days, 4/5 drinks in a 2-hour period (female/male))
  16. Pregnant, trying to become pregnant or breastfeeding
  17. Failure to agree to use adequate protection to avoid becoming pregnant during the study
  18. Currently taking any one of the following medications:

    1. Phenytoin [Brand Name: Dilantin]
    2. Carbamazepine [Brand Name: Tegretol, Carbatrol, Equetro, Epitol]
    3. Oxcarbazepine [Brand Name: Trileptal]
    4. Primidone [Brand Name: Mysoline]
    5. Phenobarbital
    6. Bendamustine [Brand Name: Treanda]
    7. Clopidogrel [Brand Name: Plavix]
    8. Clozapine [Brand Name: Clozaril, FazaClo]
    9. Erlotinib [Brand Name: Tarceva]
    10. Flecainide [Brand Name: Tambocor]
    11. Fluvoxamine [Brand Name: Luvox]
    12. Irinotecan [Brand Name: Camptosar]
    13. Olanzapine [Brand Name: Zyprexa]
    14. Tacrine [Brand Name: Cognex]
    15. Theophylline [Brand Name: Theo Dur]
  19. CO reading >80 ppm
  20. Systolic BP greater than or equal to 160 mm/Hg

    a. Participants failing for blood pressure will be allowed to re-screen once.

  21. Diastolic BP greater than or equal to 100 mm/Hg

    a. Participants failing for blood pressure will be allowed to re-screen once.

  22. Systolic BP below 90 mm/Hg

    a. Participants failing for blood pressure will be allowed to re-screen once.

  23. Diastolic BP below 50 mm/Hg

    a. Participants failing for blood pressure will be allowed to re-screen once.

  24. Heart rate greater than or equal to 105 bpm

    a. Participants failing for heart rate will be allowed to re-screen once.

  25. Heart rate lower than 45 bpm

    a. Participants failing for heart rate will be allowed to re-screen once.

  26. Indicating any suicidal ideation in the past month or suicide attempts in the past 5 years (if within the past 6-10 years, LMM approval required).
  27. Inability to independently read and comprehend the consent form and other written study materials and measures.
  28. Having participated in a research study during the past three months in which the participant:

    1. Smoked a cigarette that was not his/her usual brand cigarette for more than one day
    2. Used any tobacco products beyond normal use for more than one day
    3. Used any nicotine replacement products or smoking cessation medications for more than one day
  29. Having participated in prior studies involving reduced nicotine cigarettes in the past three years.
  30. Household member enrolled in the study concurrently
  31. Self-reported allergies to propylene glycol and/or vegetable glycerin.
  32. Previous adverse reactions when using vaping devices.

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): NCT03185546


Contacts
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Contact: Stephanie Bunch 336-702-9036 sbunch@wakehealth.edu
Contact: Eric C Donny, PhD 336-713-1520 edonny@wakehealth.edu

Locations
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United States, North Carolina
Wake Forest Biotech Place Recruiting
Winston-Salem, North Carolina, United States, 27101
Contact: Stephanie Bunch    336-702-9036    sbunch@wakehealth.edu   
Contact: Shaleema Jenkins    336-702-9037    smjenkin@wakehealth.edu   
United States, Pennsylvania
University of Pennsylvania Active, not recruiting
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Wake Forest University Health Sciences
University of Pennsylvania
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Eric Donny, PhD Wake Forest University Health Sciences

Publications:
Congress (2009). Family Smoking Prevention and Tobacco Control Act. (H.R. 1256). U. S. Congress. Washington, D.C., U.S. Government Printing Office.

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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT03185546     History of Changes
Other Study ID Numbers: U54DA031659-06 ( U.S. NIH Grant/Contract )
1U54DA031659-01 ( U.S. NIH Grant/Contract )
First Posted: June 14, 2017    Key Record Dates
Last Update Posted: January 11, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be available to other researchers, please contact the principal investigator for instructions.

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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 Wake Forest University Health Sciences:
smoking
vaping

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