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Low Nicotine Cigarettes Plus Electronic Cigarettes

NCT04058717 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2025-09-11

Study results available
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Summary

This study aims to determine the health effects of very low nicotine content in cigarettes, in conjunction with the availability of nicotine-containing electronic cigarettes (e-cigs) among smokers with mental health conditions (SMHC).

Conditions

  • Tobacco Dependence

Interventions

OTHER

Normal Nicotine Content research cigarettes

Research cigarettes with 11.6 mg nicotine/cigarette.

OTHER

High Nicotine e-cigarette

E-cigarette containing high nicotine e-liquid

OTHER

Very Low Nicotine Content research cigarettes

Research cigarettes with 0.2 mg nicotine/cigarette.

OTHER

Zero Nicotine e-cigarette

E-cigarette containing zero nicotine e-liquid

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • Milton S. Hershey Medical Center

    lead OTHER

Principal Investigators

  • Jonathan Foulds, PhD · Penn State College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-06-01
Primary Completion
2024-07-15
Completion
2024-08-12

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04058717 on ClinicalTrials.gov