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

Tobacco Dependence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03905928
• Other study ID #: 11837
• Status: Recruiting
• Phase: N/A
• Start date: November 4, 2019
• Est. completion date: June 30, 2024

Study information

• Verified date: August 2023
• Source: Milton S. Hershey Medical Center
• Contact: Andrea Hobkirk, PhD
• Phone: 7175310003
• Email: ahobkirk[@]pennstatehealth.psu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. completion date: June 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Aged 21-60

2. Smoke filtered cigarettes/machine-rolled cigarettes (=5 cigarettes per day) or daily e-cigarette use for past year.

3. 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.

4. Willing to supplement cigarette smoking with ECIG use for 4 weeks or replace e-cigarette with study product for 4 weeks

5. Willing to attend regular visits over a 4-week period (not planning to move, not planning extended vacation, no planned surgeries)

6. Willing to undergo two fMRI scans

7. Able to read and write in English

8. Able to understand and consent to study procedures

9. 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. Uncontrolled mental illness or substance abuse or inpatient treatment for these conditions in the past 6 months

9. 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

10. 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

11. Known allergy to propylene glycol or vegetable glycerin

12. Other member of household currently participating in the study

13. History of a seizure disorder or had a seizure in the past 12 months

14. 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

Related Conditions & MeSH terms

• Tobacco Dependence
• Tobacco Use Disorder

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Penn State Health	Hershey	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline
Primary	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.	Baseline to 4-weeks
Primary	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.	Baseline to 4-weeks
Secondary	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.	2-weeks post-randomization to 4-weeks post-randomization
Secondary	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.	Baseline to 4-weeks
Secondary	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.	2-weeks post-randomization to 4-weeks post-randomization