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Electronic Cigarette

Nicotine Electronic Cigarettes for Tobacco Addiction

N/A
Waitlist Available
Led By Jonathan Foulds, PhD
Research Sponsored by Milton S. Hershey Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10-week visit (post-treatment)
Awards & highlights

Study Summary

This trial is testing whether smokers who switch to an electronic cigarette with or without nicotine will have better health outcomes than smokers who continue to smoke regular cigarettes.

Who is the study for?
This trial is for smokers aged 21-70 who've been smoking more than 5 cigarettes daily for the past year, willing to switch to e-cigarettes. They must not have tried quitting seriously in the last month or used e-cigs recently. People with drug abuse, seizure disorders, severe health conditions like COPD, pregnant/nursing women, or those on certain medications can't join.Check my eligibility
What is being tested?
The study tests if switching from regular cigarettes to electronic ones reduces health risks. Participants will use an electronic cigarette with either nicotine (58 mg/ml) or without it and researchers will check if this switch improves health markers and affects nicotine dependence.See study design
What are the potential side effects?
Potential side effects may include irritation from propylene glycol or vegetable glycerin in e-cigarette liquid for those allergic. Nicotine-containing versions could increase dependence and carry typical nicotine-related side effects like throat hit or dizziness.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10-week visit (post-treatment)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10-week visit (post-treatment) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Urinary NNAL Concentration
Secondary outcome measures
Abstinence from cigarettes and other tobacco (not including e-cigs)
Cigarettes per Day
Cigarettes per day
+7 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Nicotine-Containing Electronic CigaretteExperimental Treatment1 Intervention
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 II: Non-Nicotine Electronic CigarettePlacebo Group1 Intervention
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.

Find a Location

Who is running the clinical trial?

Milton S. Hershey Medical CenterLead Sponsor
492 Previous Clinical Trials
2,798,717 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,464 Previous Clinical Trials
2,618,488 Total Patients Enrolled
1 Trials studying Tobacco Addiction
450 Patients Enrolled for Tobacco Addiction
Jonathan Foulds, PhDPrincipal InvestigatorThe Pennsylvania State University College of Medicine
4 Previous Clinical Trials
818 Total Patients Enrolled

Media Library

Nicotine-Containing Electronic Cigarette (Electronic Cigarette) Clinical Trial Eligibility Overview. Trial Name: NCT03625986 — N/A
Tobacco Addiction Research Study Groups: Nicotine-Containing Electronic Cigarette, Non-Nicotine Electronic Cigarette
Tobacco Addiction Clinical Trial 2023: Nicotine-Containing Electronic Cigarette Highlights & Side Effects. Trial Name: NCT03625986 — N/A
Nicotine-Containing Electronic Cigarette (Electronic Cigarette) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03625986 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any openings currently available for volunteers to join this experiment?

"Affirmative. The information available on clinicaltrials.gov reflects the fact that this medical study, initially posted for recruitment on April 22nd 2022, is presently recruiting. About 240 participants must be sourced from a single location."

Answered by AI

How can I become part of this research initiative?

"This clinical trial is recruiting 240 applicants aged between 21 and 70 who are dependent on tobacco. Additionally, they must have smoked ≥5 cigarettes daily for the last 12 months, utilise regular filtered or machine-rolled cigarettes with a filter, exhale CO measurement of at least 6 ppm during their initial visit, not attempted to quit smoking in the past month, be willing to completely switch over to an e-cig as part of this study and attend regular visits over 7 weeks; furthermore they ought to possess literacy in English and understanding/consent towards all procedures related to the investigation."

Answered by AI

How many individuals have registered for participation in the research project?

"That is correct. This clinical trial's data, which was initially posted on April 22nd 2022 and recently updated, can be found on the website of clinicaltrials.gov where it has been confirmed that this medical experiment is actively recruiting candidates with a total requirement for 240 patients from one location."

Answered by AI

Could you elucidate whether individuals of sub-20 years are eligible for this research trial?

"According to the guidelines of this study, only individuals between 21 and 70 years old can be enrolled."

Answered by AI

Who else is applying?

What site did they apply to?
The Pennsylvania State University College of Medicine
What portion of applicants met pre-screening criteria?
Met criteria
~35 spots leftby Apr 2025