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

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

Sponsors

Lead Sponsor: Milton S. Hershey Medical Center

Collaborator: National Institutes of Health (NIH)

Source Milton S. Hershey Medical Center
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.

Overall Status Recruiting
Start Date 2019-11-04
Completion Date 2023-07-01
Primary Completion Date 2022-12-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Baseline neural flavor cue-reactivity Baseline
Changes in neural flavor cue-reactivity Baseline to 4-weeks
Changes in neural flavor cue-reactivity Baseline to 4-weeks
Secondary Outcome
Measure Time Frame
ECIG dependence 2-weeks post-randomization to 4-weeks post-randomization
ECIG liking and satisfaction Baseline to 4-weeks
ECIG craving 2-weeks post-randomization to 4-weeks post-randomization
Enrollment 56
Condition
Intervention

Intervention Type: Other

Intervention Name: Nicotine Containing ECIG with tobacco flavor

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.

Arm Group Label: 18mg/ml Tobacco Flavor ECIG

Intervention Type: Other

Intervention Name: Nicotine Containing ECIG with Strawberry Vanilla Flavor

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.

Arm Group Label: 18mg/ml Strawberry Vanilla Flavor ECIG

Intervention Type: Other

Intervention Name: Placebo ECIG with Tobacco Flavor

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.

Arm Group Label: 0mg/ml Tobacco Flavor ECIG

Intervention Type: Other

Intervention Name: Placebo ECIG with Strawberry Vanilla Flavor

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.

Arm Group Label: 0mg/ml Strawberry Vanilla Flavor ECIG

Eligibility

Criteria:

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

Gender:

All

Minimum Age:

21 Years

Maximum Age:

60 Years

Healthy Volunteers:

Accepts Healthy Volunteers

Overall Contact

Last Name: Andrea Hobkirk, PhD

Phone: 7175310003

Phone Ext.: 286415

Email: [email protected]

Location
Facility: Status: Contact: Penn State Health Kenneth Houser, MS 717-531-5473
Location Countries

United States

Verification Date

2021-03-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Milton S. Hershey Medical Center

Investigator Full Name: Andrea Hobkirk, PhD

Investigator Title: Assitant Professor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 4
Arm Group

Label: 18mg/ml Tobacco Flavor ECIG

Type: Experimental

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

Label: 0mg/ml Tobacco Flavor ECIG

Type: Placebo Comparator

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

Label: 18mg/ml Strawberry Vanilla Flavor ECIG

Type: Experimental

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

Label: 0mg/ml Strawberry Vanilla Flavor ECIG

Type: Placebo Comparator

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

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Other

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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