Does Switching to Nicotine Containing Electronic Cigarettes Reduce Health Risk Markers

NCT03625986 | Completed Results DMC

• 2 other identifiers: 8948U01DA045517
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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).

Conditions

Tobacco Dependence

Keywords

smoking; electronic cigarettes; nicotine; ecig

Outcome Measures

Primary Outcomes (1)

• Urinary NNAL Concentration

  Concentration of urinary carcinogen biomarker of exposure, NNAL, corrected for creatinine

  6-week visit (post-treatment)

Secondary Outcomes (16)

• Pulmonary Function

  6-week visit (post-treatment)

• Exhaled Carbon Monoxide (CO)

  6-week visit (post-treatment)

• Urine Cotinine Concentration

  6-week visit (post-treatment)

• Blood Pressure

  6-week visit (post-treatment)

• Fagerstrom Test for Nicotine Dependence Mean Total Score

  6-week visit (post-treatment)

Study Arms (2)

Nicotine-Containing Electronic Cigarette

EXPERIMENTAL

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.

Other: Nicotine-Containing Electronic Cigarette

Non-Nicotine Electronic Cigarette

PLACEBO COMPARATOR

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.

Other: Non-Nicotine Electronic Cigarette

Interventions

Nicotine-Containing Electronic Cigarette OTHER

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.

Also known as: 58 mg/mL Nicotine Content SREC

Nicotine-Containing Electronic Cigarette

Non-Nicotine Electronic Cigarette OTHER

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.

Also known as: 0 mg/mL Nicotine Content SREC

Non-Nicotine Electronic Cigarette

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

The Pennsylvania State University College of Medicine

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder; Smoking; Vaping

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavior

Results Point of Contact

• Title: Dr. Jonathan Foulds
• Organization: Penn State College of Medicine

jfoulds@pennstatehealth.psu.edu

(717) 531-3504

Study Officials

• Jonathan Foulds, PhD

  The Pennsylvania State University College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 2, 2018
• First Posted: August 10, 2018
• Study Start: April 22, 2022
• Primary Completion: January 26, 2024
• Study Completion: February 23, 2024
• Last Updated: March 27, 2025
• Results First Posted: March 27, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)