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Establishing the Effect of Flavor on the Addictive Potential of Electronic Cigarettes

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.
 
ClinicalTrials.gov Identifier: NCT03905928
Recruitment Status : Recruiting
First Posted : April 8, 2019
Last Update Posted : March 26, 2021
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Andrea Hobkirk, PhD, Milton S. Hershey Medical Center

Tracking Information
First Submitted Date  ICMJE April 4, 2019
First Posted Date  ICMJE April 8, 2019
Last Update Posted Date March 26, 2021
Actual Study Start Date  ICMJE November 4, 2019
Estimated Primary Completion Date December 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 17, 2019)
  • Baseline neural flavor cue-reactivity [ Time Frame: Baseline ]
    Functional magnetic resonance imaging (fMRI) will be used to measure blood oxygen-level dependent (BOLD) signal in response to tobacco vs. strawberry-vanilla ECIG flavors at baseline. BOLD signal in functional circuits involved in reward processing, expectancies, and craving are of primary interest, including the ventral striatum, ACC, amygdala, lateral and medial PFC, OFC, and insula.
  • Changes in neural flavor cue-reactivity [ Time Frame: Baseline to 4-weeks ]
    Functional magnetic resonance imaging (fMRI) will be used to measure changes in blood oxygen-level dependent (BOLD) signal in response to 18 mg/ml vs. 0 mg/ml nicotine concentrations from baseline to 4-weeks post-randomization. BOLD signal in functional circuits involved in reward processing, expectancies, and craving are of primary interest, including the ventral striatum, ACC, amygdala, lateral and medial PFC, OFC, and insula.
  • Changes in neural flavor cue-reactivity [ Time Frame: Baseline to 4-weeks ]
    Functional magnetic resonance imaging (fMRI) will be used to measure changes in blood oxygen-level dependent (BOLD) signal in response to assigned vs. un-assigned flavors from baseline to 4-weeks post-randomization. BOLD signal in functional circuits involved in reward processing, expectancies, and craving are of primary interest, including the ventral striatum, ACC, amygdala, lateral and medial PFC, OFC, and insula.
Original Primary Outcome Measures  ICMJE
 (submitted: April 4, 2019)
  • Baseline neural flavor cue-reactivity [ Time Frame: Baseline ]
    Functional magnetic resonance imaging (fMRI) will be used to measure blood oxygen-level dependent (BOLD) signal in response to tobacco vs. strawberry-vanilla ECIG flavors at baseline. BOLD signal in functional circuits involved in reward processing, expectancies, and craving are of primary interest, including the ventral striatum, ACC, amygdala, lateral and medial PFC, OFC, and insula.
  • Changes in neural flavor cue-reactivity [ Time Frame: Baseline to 4-weeks ]
    Functional magnetic resonance imaging (fMRI) will be used to measure changes in blood oxygen-level dependent (BOLD) signal in response to 15 mg/ml vs. 0 mg/ml nicotine concentrations from baseline to 4-weeks post-randomization. BOLD signal in functional circuits involved in reward processing, expectancies, and craving are of primary interest, including the ventral striatum, ACC, amygdala, lateral and medial PFC, OFC, and insula.
  • Changes in neural flavor cue-reactivity [ Time Frame: Baseline to 4-weeks ]
    Functional magnetic resonance imaging (fMRI) will be used to measure changes in blood oxygen-level dependent (BOLD) signal in response to assigned vs. un-assigned flavors from baseline to 4-weeks post-randomization. BOLD signal in functional circuits involved in reward processing, expectancies, and craving are of primary interest, including the ventral striatum, ACC, amygdala, lateral and medial PFC, OFC, and insula.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 5, 2019)
  • ECIG dependence [ Time Frame: 2-weeks post-randomization to 4-weeks post-randomization ]
    Changes in self-reported ECIG dependence will be measured using the Penn State Electronic Cigarette Dependence Index. Total scores on this 10-item measure range from 0 to 20, with higher scores indicating higher levels of dependence.
  • ECIG liking and satisfaction [ Time Frame: Baseline to 4-weeks ]
    Changes in subjective experiences of ECIG use related to liking and satisfaction will be collected via a self-report survey. The survey consists of 21-items (7-reversed scored) with response options on a 7-point likert scale and total scores ranging from 0 to 126. Higher scores indicate more ECIG liking and satisfaction.
  • ECIG craving [ Time Frame: 2-weeks post-randomization to 4-weeks post-randomization ]
    Changes in self-reported ECIG craving will be measured with 3 questions on amount, intensity, and self-control during a state of nicotine withdrawal using visual analogue scales ranging from 0 to 10. Total scores range from 0 to 30 and higher scores indicate more craving.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 4, 2019)
  • ECIG dependence [ Time Frame: 2-weeks post-randomization to 4-weeks post-randomization ]
    Changes in self-reported ECIG dependence will be measured using the Penn State Electronic Cigarette Dependence Index.
  • ECIG liking and satisfaction [ Time Frame: Baseline to 4-weeks ]
    Changes in subjective experiences of ECIG use related to liking and satisfaction will be collected via self-report survey.
  • ECIG craving [ Time Frame: 2-weeks post-randomization to 4-weeks post-randomization ]
    Changes in self-reported ECIG craving will be measured during a state of nicotine withdrawal using visual analogue scale ratings.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Establishing the Effect of Flavor on the Addictive Potential of Electronic Cigarettes
Official Title  ICMJE Establishing the Effect of Flavor on the Addictive Potential of Electronic Cigarettes
Brief Summary The current study aims to establish proof-of-concept that neural cue-reactivity can serve as an early, objective marker of electronic cigarette (ECIG) addictive potential. Further, this study will examine the effect of flavor and nicotine concentration on the addictive potential of ECIGs to aid research informing U.S. Food and Drug Administration (FDA) flavor regulations and smoking cessation.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE Tobacco Dependence
Intervention  ICMJE
  • Other: Nicotine Containing ECIG with tobacco flavor
    Participants will be provided with an EGO style ECIG to be used for 28 days. The EGO style ECIG is a "vape pen-style" device that comprises of a rechargeable battery and a tank containing liquid. Those in this intervention group will receive an ECIG with 18mg/ml nicotine concentration and a tobacco flavor.
  • Other: Nicotine Containing ECIG with Strawberry Vanilla Flavor
    Participants will be provided with an EGO style ECIG to be used for 28 days. The EGO style ECIG is a "vape pen-style" device that comprises of a rechargeable battery and a tank containing liquid. Those in this intervention group will receive an ECIG with 18mg/ml nicotine concentration and a strawberry vanilla flavor.
  • Other: Placebo ECIG with Tobacco Flavor
    Participants will be provided with an EGO style ECIG to be used for 28 days. The EGO style ECIG is a "vape pen-style" device that comprises of a rechargeable battery and a tank containing liquid. Those in this intervention group will receive an ECIG with 0mg/ml nicotine concentration and a tobacco flavor.
  • Other: Placebo ECIG with Strawberry Vanilla Flavor
    Participants will be provided with an EGO style ECIG to be used for 28 days. The EGO style ECIG is a "vape pen-style" device that comprises of a rechargeable battery and a tank containing liquid. Those in this intervention group will receive an ECIG with 0mg/ml nicotine concentration and a strawberry vanilla flavor.
Study Arms  ICMJE
  • Experimental: 18mg/ml Tobacco Flavor ECIG
    Participants will be provided with an ECIG containing 15mg/ml nicotine concentration and a tobacco flavor.
    Intervention: Other: Nicotine Containing ECIG with tobacco flavor
  • Placebo Comparator: 0mg/ml Tobacco Flavor ECIG
    Participants will be provided with an ECIG containing 0mg/ml nicotine concentration and a tobacco flavor.
    Intervention: Other: Placebo ECIG with Tobacco Flavor
  • Experimental: 18mg/ml Strawberry Vanilla Flavor ECIG
    Participants will be provided with an ECIG containing 15mg/ml nicotine concentration and a strawberry vanilla flavor.
    Intervention: Other: Nicotine Containing ECIG with Strawberry Vanilla Flavor
  • Placebo Comparator: 0mg/ml Strawberry Vanilla Flavor ECIG
    Participants will be provided with an ECIG containing 0mg/ml nicotine concentration and a strawberry vanilla flavor.
    Intervention: Other: Placebo ECIG with Strawberry Vanilla Flavor
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 4, 2019)
56
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 1, 2023
Estimated Primary Completion Date December 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Aged 21-60
  2. Smoke ≥5 cigarettes per day
  3. Smoke regular, filtered cigarettes or machine-rolled cigarettes with a filter for past year
  4. Smoke regular, tobacco flavored cigarettes
  5. No serious quit attempt in prior month. This includes use of any FDA approved smoking cessation medication (varenicline, bupropion [used specifically as a quitting aid], patch, gum, lozenge, inhaler, and nasal spray) in the past 1 month as an indication of treatment seeking.
  6. Willing to supplement cigarette smoking with ECIG use for 4 weeks
  7. Willing to attend regular visits over a 4-week period (not planning to move, not planning extended vacation, no planned surgeries)
  8. Willing to undergo two fMRI scans
  9. Able to read and write in English
  10. Able to understand and consent to study procedures
  11. Access to computer with internet service that allows for use of Zoom

Exclusion Criteria:

  1. Impaired smell function as measured via a standardized screening assessment
  2. Unstable or significant medical condition in the past 12 months (recent heart attack or some other heart conditions, stroke, severe angina including high blood pressure)
  3. Severe immune system disorders (uncontrolled Human Immunodeficiency virus infection; unstable multiple sclerosis symptoms), respiratory diseases (exacerbations of asthma or chronic obstructive pulmonary disorder, require oxygen, require oral prednisone), kidney (dialysis) or liver diseases (cirrhosis), or any medical disorder/medication that may affect participant safety or biomarker data
  4. Women who are pregnant (verified by urine pregnancy test at any visit), trying to become pregnant, or nursing
  5. Medical conditions associated with cognitive impairment or neurological dysfunction
  6. Severe claustrophobia
  7. Current depressive or anxiety disorder
  8. Past 7 day use of any flavored tobacco product
  9. Past 7 day use of any electronic cigarette device or use for more than 5 days in the past 28 days
  10. Uncontrolled mental illness or substance abuse or inpatient treatment for these conditions in the past 6 months
  11. Use of illicit drugs or prescription drugs for non-medical use daily/almost daily or weekly in the past 3 months per National Institute on Drug Abuse (NIDA) Quick Screen, not including use of marijuana
  12. Any known risk from exposure to high-field strength magnetic fields (e.g., cardiac pacemakers), any irremovable metallic foreign objects in their body (e.g., braces), or a questionable history of metallic fragments which are likely to create artifact on the MRI scans
  13. Use of menthol flavored cigarettes
  14. Known allergy to propylene glycol or vegetable glycerin
  15. Other member of household currently participating in the study
  16. History of a seizure disorder or had a seizure in the past 12 months
  17. Currently taking medications prescribed to prevent seizures (such as Carbamazepine or Phenobarbital). Using seizure medications for off-label use (indications other than treatment for seizures) will not be included as an exclusion, these will be assessed on a case-by-case basis
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Andrea Hobkirk, PhD 7175310003 ext 286415 ahobkirk@pennstatehealth.psu.edu
Contact: Kenneth Houser, MS 7175315473 khouser@pennstatehealth.psu.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03905928
Other Study ID Numbers  ICMJE 11837
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Andrea Hobkirk, PhD, Milton S. Hershey Medical Center
Study Sponsor  ICMJE Milton S. Hershey Medical Center
Collaborators  ICMJE National Institutes of Health (NIH)
Investigators  ICMJE Not Provided
PRS Account Milton S. Hershey Medical Center
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP