Back to resultsDoes Switching to Nicotine Containing Electronic Cigarettes Reduce Health Risk Markers
Primary Purpose
Tobacco Dependence
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nicotine-Containing Electronic Cigarette
Non-Nicotine Electronic Cigarette
Sponsored by
About this trial
This is an interventional other trial for Tobacco Dependence focused on measuring smoking, electronic cigarettes, nicotine, ecig
Eligibility Criteria
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
Sites / Locations
- The Pennsylvania State University College of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Nicotine-Containing Electronic Cigarette
Non-Nicotine Electronic Cigarette
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Urinary NNAL Concentration
Concentration of urinary carcinogen biomarker of exposure, NNAL, corrected for creatinine
Secondary Outcome Measures
Pulmonary Function
Forced expiratory volume in one second (FEV1).
Exhaled Carbon Monoxide (CO)
Exhaled CO (parts per million [ppm])
Plasma Cotinine Concentration
Cotinine (ng/ml) will serve as a measure of exposure to nicotine.
Fagerstrom Test for Nicotine Dependence Mean Total Score
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).
Cigarettes per Day
Mean number of cigarettes smoked per day based on the past 7 days
Abstinence from cigarettes and other tobacco (not including e-cigs)
Zero cigarettes or other tobacco products (not including e-cigs) used in the past days and a CO <6ppm
Total Score on Minnesota Nicotine Withdrawal Scale
Withdrawal and craving will be assessed via the Minnesota Nicotine Withdrawal Scale. Total scores range from 0-28.
Cigarettes per day
Mean number of cigarettes smoked per day based on the past 7 days
E-cig use days
The number of days the e-cig was used in the past 21 days
Self-reported abstinence
Abstinence will be considered zero cigarettes and other tobacco products (not including e-cigs) in the past 7 days
Full Information
NCT ID
NCT03625986
First Posted
August 2, 2018
Last Updated
May 1, 2023
Sponsor
Milton S. Hershey Medical Center
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT03625986
Brief Title
Does Switching to Nicotine Containing Electronic Cigarettes Reduce Health Risk Markers
Official Title
Does Switching to Nicotine Containing Electronic Cigarettes Reduce Health Risk Markers
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 22, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Milton S. Hershey Medical Center
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Dependence
Keywords
smoking, electronic cigarettes, nicotine, ecig
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
104 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Nicotine-Containing Electronic Cigarette
Arm Type
Experimental
Arm Description
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.
Arm Title
Non-Nicotine Electronic Cigarette
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Nicotine-Containing Electronic Cigarette
Other Intervention Name(s)
58 mg/mL Nicotine Content SREC
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Non-Nicotine Electronic Cigarette
Other Intervention Name(s)
0 mg/mL Nicotine Content SREC
Intervention Description
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.
Primary Outcome Measure Information:
Title
Urinary NNAL Concentration
Description
Concentration of urinary carcinogen biomarker of exposure, NNAL, corrected for creatinine
Time Frame
6-week visit (post-treatment)
Secondary Outcome Measure Information:
Title
Pulmonary Function
Description
Forced expiratory volume in one second (FEV1).
Time Frame
6-week visit (post-treatment)
Title
Exhaled Carbon Monoxide (CO)
Description
Exhaled CO (parts per million [ppm])
Time Frame
6-week visit (post-treatment)
Title
Plasma Cotinine Concentration
Description
Cotinine (ng/ml) will serve as a measure of exposure to nicotine.
Time Frame
6-week visit (post-treatment)
Title
Fagerstrom Test for Nicotine Dependence Mean Total Score
Description
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).
Time Frame
6-week visit (post-treatment)
Title
Cigarettes per Day
Description
Mean number of cigarettes smoked per day based on the past 7 days
Time Frame
6-week visit (post-treatment)
Title
Abstinence from cigarettes and other tobacco (not including e-cigs)
Description
Zero cigarettes or other tobacco products (not including e-cigs) used in the past days and a CO <6ppm
Time Frame
6-week visit (post-treatment)
Title
Total Score on Minnesota Nicotine Withdrawal Scale
Description
Withdrawal and craving will be assessed via the Minnesota Nicotine Withdrawal Scale. Total scores range from 0-28.
Time Frame
1-week visit (post-treatment)
Title
Cigarettes per day
Description
Mean number of cigarettes smoked per day based on the past 7 days
Time Frame
10-week visit (post-treatment)
Title
E-cig use days
Description
The number of days the e-cig was used in the past 21 days
Time Frame
10-week visit (post-treatment)
Title
Self-reported abstinence
Description
Abstinence will be considered zero cigarettes and other tobacco products (not including e-cigs) in the past 7 days
Time Frame
10-week visit (post-treatment)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jessica Yingst, DrPH
Phone
7175314637
Email
jyingst@phs.psu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Nicolle Krebs, MS
Phone
7175315673
Email
nkrebs@pennstatehealth.psu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Foulds, PhD
Organizational Affiliation
The Pennsylvania State University College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Pennsylvania State University College of Medicine
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan Foulds, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
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Does Switching to Nicotine Containing Electronic Cigarettes Reduce Health Risk Markers
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