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

Primary Purpose

Tobacco Dependence

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nicotine Containing ECIG with tobacco flavor
Nicotine Containing ECIG with Strawberry Vanilla Flavor
Placebo ECIG with Tobacco Flavor
Placebo ECIG with Strawberry Vanilla Flavor
Sponsored by
Milton S. Hershey Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Tobacco Dependence focused on measuring smoking, electronic cigarettes, flavor, cue-reactivity

Eligibility Criteria

21 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Aged 21-60
  2. Smoke ≥5 cigarettes per day
  3. Smoke filtered cigarettes or machine-rolled cigarettes with a filter for past year
  4. 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.
  5. Willing to supplement cigarette smoking with ECIG use for 4 weeks
  6. Willing to attend regular visits over a 4-week period (not planning to move, not planning extended vacation, no planned surgeries)
  7. Willing to undergo two fMRI scans
  8. Able to read and write in English
  9. Able to understand and consent to study procedures
  10. 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 electronic cigarette device or use for more than 5 days in the past 28 days
  9. Uncontrolled mental illness or substance abuse or inpatient treatment for these conditions in the past 6 months
  10. 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
  11. 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
  12. Known allergy to propylene glycol or vegetable glycerin
  13. Other member of household currently participating in the study
  14. History of a seizure disorder or had a seizure in the past 12 months
  15. 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

Sites / Locations

  • Penn State HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

18mg/ml Tobacco Flavor ECIG

0mg/ml Tobacco Flavor ECIG

18mg/ml Strawberry Vanilla Flavor ECIG

0mg/ml Strawberry Vanilla Flavor ECIG

Arm Description

Participants will be provided with an ECIG containing 15mg/ml nicotine concentration and a tobacco flavor.

Participants will be provided with an ECIG containing 0mg/ml nicotine concentration and a tobacco flavor.

Participants will be provided with an ECIG containing 15mg/ml nicotine concentration and a strawberry vanilla flavor.

Participants will be provided with an ECIG containing 0mg/ml nicotine concentration and a strawberry vanilla flavor.

Outcomes

Primary Outcome Measures

Baseline neural flavor cue-reactivity
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
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
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.

Secondary Outcome Measures

ECIG dependence
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
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
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.

Full Information

First Posted
April 4, 2019
Last Updated
August 9, 2023
Sponsor
Milton S. Hershey Medical Center
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT03905928
Brief Title
Establishing the Effect of Flavor on the Addictive Potential of Electronic Cigarettes
Official Title
Establishing the Effect of Flavor on the Addictive Potential of Electronic Cigarettes
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 4, 2019 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Milton S. Hershey Medical Center
Collaborators
National Institutes of Health (NIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Dependence
Keywords
smoking, electronic cigarettes, flavor, cue-reactivity

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
56 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
18mg/ml Tobacco Flavor ECIG
Arm Type
Experimental
Arm Description
Participants will be provided with an ECIG containing 15mg/ml nicotine concentration and a tobacco flavor.
Arm Title
0mg/ml Tobacco Flavor ECIG
Arm Type
Placebo Comparator
Arm Description
Participants will be provided with an ECIG containing 0mg/ml nicotine concentration and a tobacco flavor.
Arm Title
18mg/ml Strawberry Vanilla Flavor ECIG
Arm Type
Experimental
Arm Description
Participants will be provided with an ECIG containing 15mg/ml nicotine concentration and a strawberry vanilla flavor.
Arm Title
0mg/ml Strawberry Vanilla Flavor ECIG
Arm Type
Placebo Comparator
Arm Description
Participants will be provided with an ECIG containing 0mg/ml nicotine concentration and a strawberry vanilla flavor.
Intervention Type
Other
Intervention Name(s)
Nicotine Containing ECIG with tobacco flavor
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Nicotine Containing ECIG with Strawberry Vanilla Flavor
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo ECIG with Tobacco Flavor
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo ECIG with Strawberry Vanilla Flavor
Intervention Description
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.
Primary Outcome Measure Information:
Title
Baseline neural flavor cue-reactivity
Description
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.
Time Frame
Baseline
Title
Changes in neural flavor cue-reactivity
Description
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.
Time Frame
Baseline to 4-weeks
Title
Changes in neural flavor cue-reactivity
Description
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.
Time Frame
Baseline to 4-weeks
Secondary Outcome Measure Information:
Title
ECIG dependence
Description
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.
Time Frame
2-weeks post-randomization to 4-weeks post-randomization
Title
ECIG liking and satisfaction
Description
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.
Time Frame
Baseline to 4-weeks
Title
ECIG craving
Description
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.
Time Frame
2-weeks post-randomization to 4-weeks post-randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Aged 21-60 Smoke filtered cigarettes/machine-rolled cigarettes (≥5 cigarettes per day) or daily e-cigarette use for past year. 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. Willing to supplement cigarette smoking with ECIG use for 4 weeks or replace e-cigarette with study product for 4 weeks Willing to attend regular visits over a 4-week period (not planning to move, not planning extended vacation, no planned surgeries) Willing to undergo two fMRI scans Able to read and write in English Able to understand and consent to study procedures Access to computer with internet service that allows for use of Zoom Exclusion Criteria: Impaired smell function as measured via a standardized screening assessment 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) 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 Women who are pregnant (verified by urine pregnancy test at any visit), trying to become pregnant, or nursing Medical conditions associated with cognitive impairment or neurological dysfunction Severe claustrophobia Current depressive or anxiety disorder Uncontrolled mental illness or substance abuse or inpatient treatment for these conditions in the past 6 months 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 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 Known allergy to propylene glycol or vegetable glycerin Other member of household currently participating in the study History of a seizure disorder or had a seizure in the past 12 months 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrea Hobkirk, PhD
Phone
7175310003
Ext
286415
Email
ahobkirk@pennstatehealth.psu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Kenneth Houser, MS
Phone
7175315473
Email
khouser@pennstatehealth.psu.edu
Facility Information:
Facility Name
Penn State Health
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kenneth Houser, MS
Phone
717-531-5473

12. IPD Sharing Statement

Learn more about this trial

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

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