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

NCT ID: NCT03905928

Last Updated: 2025-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-04
• Study Completion Date: 2024-04-30

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.

Conditions

Tobacco Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

18mg/ml Tobacco Flavor ECIG

Participants will be provided with an ECIG containing 18mg/ml nicotine concentration and a tobacco flavor.

Group Type: EXPERIMENTAL

Nicotine Containing ECIG with tobacco flavor

Intervention Type: OTHER

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.

0mg/ml Tobacco Flavor ECIG

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

Group Type: PLACEBO_COMPARATOR

Placebo ECIG with Tobacco Flavor

Intervention Type: OTHER

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.

18mg/ml Strawberry Vanilla Flavor ECIG

Participants will be provided with an ECIG containing 18mg/ml nicotine concentration and a strawberry vanilla flavor.

Group Type: EXPERIMENTAL

Nicotine Containing ECIG with Strawberry Vanilla Flavor

Intervention Type: OTHER

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.

0mg/ml Strawberry Vanilla Flavor ECIG

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

Group Type: PLACEBO_COMPARATOR

Placebo ECIG with Strawberry Vanilla Flavor

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Milton S. Hershey Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Andrea Hobkirk, PhD

Assitant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Penn State Health

Hershey, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

R03DA047582

Identifier Type: NIH

Identifier Source: secondary_id

View Link

11837

Identifier Type: -

Identifier Source: org_study_id