- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03625986
Does Switching to Nicotine Containing Electronic Cigarettes Reduce Health Risk Markers
The overall goal of this project is to understand the likely health effects of cigarette smokers switching to a Standardized Research Electronic Cigarette (SREC) and to assess the role of nicotine delivery on switching and acceptability as well as markers of health outcomes.
Current smokers who meet all eligibility criteria will completely switch from their combustible (regular) cigarettes to an electronic cigarette (SREC) that either contains 58 mg/ml of nicotine or 0 mg/ml of nicotine in the liquid.
The investigators' hypothesis is that attempting to switch to a SREC will result in a reduction in markers of harms to health, as compared with the baseline (smoking) measures. The investigators also hypothesize that nicotine-containing SRECs will facilitate switching from smoking more efficiently than zero nicotine SRECs and will result in a significantly greater improvement in markers of health risk, but will result in higher ratings of dependence on the SREC (as compared to the zero nicotine SREC).
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This project is a prospective parallel-group randomized double-blind, placebo-controlled study in which 104 current smokers who are willing to completely switch from their regular cigarettes to an electronic cigarette (SREC) for 6 weeks will be randomly allocated to use a SREC containing either 58 or 0 mg/ml nicotine in the liquid.
Following randomization to their assigned study product, participants will be supported in their switching efforts with regular contacts both in person at the Penn State Milton S. Hershey Medical Center and over the phone. The main measures will be recorded at two in-person visits after the randomization (switching) visit: (a) 3 weeks after switching and (b) 6 weeks after switching. All participants will also be followed up at 10 weeks by phone to identify whether they have continued to use electronic cigarettes or regular cigarettes and to assess their motivation to change.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jessica Yingst, DrPH
- Phone Number: 7175314637
- Email: jyingst@phs.psu.edu
Study Contact Backup
- Name: Nicolle Krebs, MS
- Phone Number: 7175315673
- Email: nkrebs@pennstatehealth.psu.edu
Study Locations
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Pennsylvania
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Hershey, Pennsylvania, United States, 17033
- The Pennsylvania State University College of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 21 to 70
- Smoke ≥5 cigarettes per day for at least the past 12 months
- Smoke regular, filtered cigarettes or machine-rolled cigarettes with a filter
- Exhaled CO measurement ≥6 ppm at baseline visit
- No serious quit attempt in prior month
- Willing to completely cease cigarette consumption and switch to an e-cig
- Willing and able to attend regular visits over a 7-week period
- Able to read and write in English
- Able to understand and consent to study procedures
Exclusion Criteria:
- Unstable or significant medical condition such as COPD, kidney disease, or liver disease in the past 12 months
- Severe immune system disorders
- Women who are pregnant, trying to become pregnant, or nursing
- Use of any non-cigarette nicotine delivery product in the past 7 days
- Use of an e-cig for 5 or more days in the past 28 days or any use in the past 7 days
- Uncontrolled mental illness or substance abuse or inpatient treatment for these conditions in the past 6 months
- History of a seizure disorder or had a seizure in the past 12 months
- Currently or have ever taken 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.
- History of difficulty providing or unwilling to provide blood samples (fainting, poor veins, anxiety, seizures)
- Surgery requiring general anesthesia in the past 6 weeks
- Use of marijuana or any illicit drug/prescription drugs for non-medical use daily/almost daily or weekly in the past 3 months per NIDA Quick Screen
- Use of hand-rolled, roll your own cigarettes
- Known allergy to propylene glycol or vegetable glycerin
- Other member of household currently participating in the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Nicotine-Containing Electronic Cigarette
The experimental group will be provided with and encouraged to use a Standardized Research Electronic Cigarette (SREC) with liquid containing 58 mg/ml nicotine for the duration of 6 weeks.
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The electronic cigarette (e-cig) used in this study will be the Standardized Research Electronic Cigarette (SREC).
The SREC product is a pod-based device and comprises a replaceable pre-filled liquid reservoir ("pod") and a rechargeable power supply unit.
The experimental group in this project will receive a SREC device with liquid containing 58 mg/mL of nicotine.
Other Names:
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Placebo Comparator: Non-Nicotine Electronic Cigarette
The placebo group will be provided with and encouraged to use a Standardized Research Electronic Cigarette (SREC) with liquid containing 0 mg/ml nicotine for the duration of 6 weeks.
|
The electronic cigarette (e-cig) used in this study will be the Standardized Research Electronic Cigarette (SREC).
The SREC product is a pod-based device and comprises a replaceable pre-filled liquid reservoir ("pod") and a rechargeable power supply unit.
The placebo group in this project will receive a SREC device with liquid containing 0 mg/mL of nicotine.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Urinary NNAL Concentration
Time Frame: 6-week visit (post-treatment)
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Concentration of urinary carcinogen biomarker of exposure, NNAL, corrected for creatinine
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6-week visit (post-treatment)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pulmonary Function
Time Frame: 6-week visit (post-treatment)
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Forced expiratory volume in one second (FEV1).
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6-week visit (post-treatment)
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Exhaled Carbon Monoxide (CO)
Time Frame: 6-week visit (post-treatment)
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Exhaled CO (parts per million [ppm])
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6-week visit (post-treatment)
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Plasma Cotinine Concentration
Time Frame: 6-week visit (post-treatment)
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Cotinine (ng/ml) will serve as a measure of exposure to nicotine.
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6-week visit (post-treatment)
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Fagerstrom Test for Nicotine Dependence Mean Total Score
Time Frame: 6-week visit (post-treatment)
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Nicotine dependence will be assessed via the Fagerstrom Test for Nicotine Dependence (FTND), a measure with total scores ranging from 0 (very low dependence) to 10 (very high dependence).
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6-week visit (post-treatment)
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Cigarettes per Day
Time Frame: 6-week visit (post-treatment)
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Mean number of cigarettes smoked per day based on the past 7 days
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6-week visit (post-treatment)
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Abstinence from cigarettes and other tobacco (not including e-cigs)
Time Frame: 6-week visit (post-treatment)
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Zero cigarettes or other tobacco products (not including e-cigs) used in the past days and a CO <6ppm
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6-week visit (post-treatment)
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Total Score on Minnesota Nicotine Withdrawal Scale
Time Frame: 1-week visit (post-treatment)
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Withdrawal and craving will be assessed via the Minnesota Nicotine Withdrawal Scale.
Total scores range from 0-28.
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1-week visit (post-treatment)
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Cigarettes per day
Time Frame: 10-week visit (post-treatment)
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Mean number of cigarettes smoked per day based on the past 7 days
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10-week visit (post-treatment)
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E-cig use days
Time Frame: 10-week visit (post-treatment)
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The number of days the e-cig was used in the past 21 days
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10-week visit (post-treatment)
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Self-reported abstinence
Time Frame: 10-week visit (post-treatment)
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Abstinence will be considered zero cigarettes and other tobacco products (not including e-cigs) in the past 7 days
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10-week visit (post-treatment)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jonathan Foulds, PhD, The Pennsylvania State University College of Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Substance-Related Disorders
- Tobacco Use Disorder
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Cholinergic Agents
- Ganglionic Stimulants
- Nicotinic Agonists
- Cholinergic Agonists
- Nicotine
Other Study ID Numbers
- 8948 (Tabriz University of Medical Sciences)
- U01DA045517 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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