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

Penn State Health

Status: Completed

Conditions: Tobacco Dependence

Treatments: Other: Placebo ECIG with Strawberry Vanilla Flavor; Other: Placebo ECIG with Tobacco Flavor; Other: Nicotine Containing ECIG with Strawberry Vanilla Flavor; Other: Nicotine Containing ECIG with tobacco flavor

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03905928

11837

R03DA047582 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 19 patients

Sex: All

Ages: 21 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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19 participants in 4 patient groups, including a placebo group

18mg/ml Tobacco Flavor ECIG

Experimental group

Description:

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

Treatment:

Other: Nicotine Containing ECIG with tobacco flavor

0mg/ml Tobacco Flavor ECIG

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo ECIG with Tobacco Flavor

18mg/ml Strawberry Vanilla Flavor ECIG

Experimental group

Description:

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

Treatment:

Other: Nicotine Containing ECIG with Strawberry Vanilla Flavor

0mg/ml Strawberry Vanilla Flavor ECIG

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo ECIG with Strawberry Vanilla Flavor