Does Switching to Nicotine Containing Electronic Cigarettes Reduce Health Risk Markers
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Smoking Cessation, Tobacco Consumers |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 2/17/2019 |
| Start Date: | March 2019 |
| End Date: | September 2020 |
| Contact: | Jessica Yingst, DrPH |
| Email: | jyingst@phs.psu.edu |
| Phone: | 7175314637 |
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 15
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).
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 15
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).
This project is a prospective parallel-group randomized double-blind, placebo-controlled
study in which 240 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 15 or 0 mg/ml nicotine in the liquid. All participants will take part
in a 1-week baseline period to assess normal smoking behavior prior to double-blind
randomization.
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 in which 240 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 15 or 0 mg/ml nicotine in the liquid. All participants will take part
in a 1-week baseline period to assess normal smoking behavior prior to double-blind
randomization.
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.
Inclusion Criteria:
- 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 difficulty providing or unwilling to provide blood samples (fainting, poor
veins, anxiety)
- 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
We found this trial at
1
site
Hershey, Pennsylvania 17033
Principal Investigator: Jonathan Foulds, PhD
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