Does Switching to Nicotine Containing Electronic Cigarettes Reduce Health Risk Markers

NCT ID: NCT03625986

Last Updated: 2025-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-22
• Study Completion Date: 2024-02-23

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.

Conditions

Tobacco Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Nicotine-Containing Electronic Cigarette

Intervention Type: 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.

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.

Group Type: PLACEBO_COMPARATOR

Non-Nicotine Electronic Cigarette

Intervention Type: 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.

Interventions

Nicotine-Containing Electronic Cigarette

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

Non-Nicotine Electronic Cigarette

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.

Intervention Type: OTHER

Other Intervention Names

58 mg/mL Nicotine Content SREC; 0 mg/mL Nicotine Content SREC

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Milton S. Hershey Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Jonathan Foulds

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jonathan Foulds, PhD

Role: PRINCIPAL_INVESTIGATOR

The Pennsylvania State University College of Medicine

Locations

The Pennsylvania State University College of Medicine

Hershey, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

U01DA045517

Identifier Type: NIH

Identifier Source: secondary_id

View Link

8948

Identifier Type: -

Identifier Source: org_study_id