Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03905928
Recruitment Status : Recruiting
First Posted : April 8, 2019
Last Update Posted : September 19, 2019
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Andrea Hobkirk, 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.

Condition or disease Intervention/treatment Phase
Tobacco Dependence Other: Nicotine Containing ECIG with tobacco flavor Other: Nicotine Containing ECIG with Strawberry Vanilla Flavor Other: Placebo ECIG with Tobacco Flavor Other: Placebo ECIG with Strawberry Vanilla Flavor Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Establishing the Effect of Flavor on the Addictive Potential of Electronic Cigarettes
Estimated Study Start Date : September 30, 2019
Estimated Primary Completion Date : February 1, 2020
Estimated Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: E-Cigarettes

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.
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.

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

Experimental: 18mg/ml Strawberry Vanilla Flavor ECIG
Participants will be provided with an ECIG containing 15mg/ml nicotine concentration and a strawberry vanilla flavor.
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.

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.
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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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. 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.

  3. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Aged 18-60
  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

Exclusion Criteria:

  1. Impaired smell function as measured on the Burgrhart Sniffin' Sticks 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03905928


Contacts
Layout table for location contacts
Contact: Andrea Hobkirk, PhD 7175310003 ext 286415 ahobkirk@pennstatehealth.psu.edu
Contact: Kenneth Houser, MS 7175315473 khouser@pennstatehealth.psu.edu

Locations
Layout table for location information
United States, Pennsylvania
Penn State Health Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Kenneth Houser, MS    717-531-5473      
Sponsors and Collaborators
Milton S. Hershey Medical Center
National Institutes of Health (NIH)

Layout table for additonal information
Responsible Party: Andrea Hobkirk, Assitant Professor, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT03905928     History of Changes
Other Study ID Numbers: 11837
First Posted: April 8, 2019    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: September 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Andrea Hobkirk, Milton S. Hershey Medical Center:
smoking
electronic cigarettes
flavor
cue-reactivity
Additional relevant MeSH terms:
Layout table for MeSH terms
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action