- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03905928
Establishing the Effect of Flavor on the Addictive Potential of Electronic Cigarettes
August 9, 2023 updated by: Andrea Hobkirk, PhD, Milton S. Hershey Medical Center
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.
Study Overview
Status
Recruiting
Conditions
Study Type
Interventional
Enrollment (Estimated)
56
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Andrea Hobkirk, PhD
- Phone Number: 286415 7175310003
- Email: ahobkirk@pennstatehealth.psu.edu
Study Contact Backup
- Name: Kenneth Houser, MS
- Phone Number: 7175315473
- Email: khouser@pennstatehealth.psu.edu
Study Locations
-
-
Pennsylvania
-
Hershey, Pennsylvania, United States, 17033
- Recruiting
- Penn State Health
-
Contact:
- Kenneth Houser, MS
- Phone Number: 717-531-5473
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 18mg/ml Tobacco Flavor ECIG
Participants will be provided with an ECIG containing 15mg/ml nicotine concentration and a 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.
|
Placebo Comparator: 0mg/ml Tobacco Flavor ECIG
Participants will be provided with an ECIG containing 0mg/ml nicotine concentration and a 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.
|
Experimental: 18mg/ml Strawberry Vanilla Flavor ECIG
Participants will be provided with an ECIG containing 15mg/ml nicotine concentration and a 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.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline
|
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.
|
Baseline to 4-weeks
|
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.
|
Baseline to 4-weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
2-weeks post-randomization to 4-weeks post-randomization
|
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.
|
Baseline to 4-weeks
|
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.
|
2-weeks post-randomization to 4-weeks post-randomization
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 4, 2019
Primary Completion (Estimated)
April 30, 2024
Study Completion (Estimated)
June 30, 2024
Study Registration Dates
First Submitted
April 4, 2019
First Submitted That Met QC Criteria
April 4, 2019
First Posted (Actual)
April 8, 2019
Study Record Updates
Last Update Posted (Actual)
August 14, 2023
Last Update Submitted That Met QC Criteria
August 9, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Substance-Related Disorders
- Tobacco Use Disorder
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Cholinergic Agents
- Ganglionic Stimulants
- Nicotinic Agonists
- Cholinergic Agonists
- Nicotine
Other Study ID Numbers
- 11837
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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