Clinical trial NCT03625986: 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
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Dependence
Keywords: smoking
electronic cigarettes
nicotine
ecig
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2018-08-10
Enrollment: 105
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Urinary NNAL Concentration
timeFrame: 6-week visit (post-treatment)
Secondary outcomes:
measure: Pulmonary Function
timeFrame: 6-week visit (post-treatment)
measure: Exhaled Carbon Monoxide (CO)
timeFrame: 6-week visit (post-treatment)
measure: Urine Cotinine Concentration
timeFrame: 6-week visit (post-treatment)
measure: Blood Pressure
timeFrame: 6-week visit (post-treatment)
measure: Fagerstrom Test for Nicotine Dependence Mean Total Score
timeFrame: 6-week visit (post-treatment)
measure: Penn State Electronic Cigarette Dependence Index
timeFrame: 6-week visit (post-treatment)
measure: Cigarettes Per Day
timeFrame: 6-week visit (post-treatment)
measure: Number of Participants With Abstinence From Cigarettes and Other Tobacco (Not Including E-cigs)
timeFrame: 6-week visit (post-treatment)
measure: Total Score on Minnesota Nicotine Withdrawal Scale
timeFrame: 1-week visit (post-treatment)
measure: Cigarettes Per Day
timeFrame: 10-week visit (post-treatment)
measure: E-cig Use Days
timeFrame: 10-week visit (post-treatment)
measure: Number of Participants With Self-reported Abstinence
timeFrame: 10-week visit (post-treatment)
measure: Heart Rate Variability (HRV)
timeFrame: 6-week visit (post-treatment)
measure: Presence of Premature Ventricular Contractions (PVCs)
timeFrame: 6-week visit (post-treatment)
measure: ST-Elevation
timeFrame: 6-week visit (post-treatment)
measure: QRS Duration
timeFrame: 6-week visit (post-treatment)
Other outcomes:
Locations:
city: Hershey
country: United States
facility: The Pennsylvania State University College of Medicine
state: Pennsylvania
Study officials:
affiliation: The Pennsylvania State University College of Medicine
name: Jonathan Foulds, PhD
role: PRINCIPAL_INVESTIGATOR
References: