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Nicotine Replacement

Vaping vs. Nicotine Replacement for Smoking Behavior

N/A
Recruiting
Led By Theodore L Wagener, PhD
Research Sponsored by Ohio State University Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
>= 21 years old
Be older than 18 years old
Must not have
Serious angina pectoris or chest pain
Diagnosed medical conditions of lung disease, asthma, cystic fibrosis, heart disease or chronic obstructive pulmonary disease (COPD)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 2, 6, 14, and 26 weeks
Awards & highlights

Summary

This trial compares tobacco flavored electronic cigarettes to non-tobacco flavored electronic cigarettes and nicotine replacement therapy (patches and lozenges) in current cigarette smokers. The goal is to see if ECs

Who is the study for?
This trial is for current cigarette smokers who are interested in trying electronic cigarettes (ECs) or nicotine replacement therapy to reduce smoking. Specific eligibility criteria details were not provided, so it's unclear who exactly can or cannot participate.
What is being tested?
The study compares the impact of tobacco-flavored ECs versus non-tobacco flavored ECs and traditional nicotine replacements on smoking habits. It aims to see if different flavors affect the appeal and usage of ECs, as well as their effectiveness in reducing cigarette cravings and dependence.
What are the potential side effects?
Potential side effects may include irritation from vaping, possible nicotine withdrawal symptoms when switching from cigarettes to ECs or NRT, and typical reactions to nicotine replacements like skin irritation from patches or mouth issues from lozenges.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 21 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I experience severe chest pain.
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I have a diagnosed condition like asthma, COPD, heart or lung disease.
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My high blood pressure is not controlled by medication.
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I have not had a stroke in the last three months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 2, 6, 14, and 26 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 2, 6, 14, and 26 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Biochemically verified 7-day point prevalence abstinence from cigarettes
Switching rate
Secondary study objectives
Change in nicotine dependence
Changes in cigarette craving and nicotine withdrawal
Cigarettes smoked per day
+3 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Arm II (TEC)Experimental Treatment2 Interventions
Participants receive TEC for 14 weeks, including a 2-week pre-switch period to become familiar with usage. Participants in all arms participate in discussions throughout the trial.
Group II: Arm I (PEC)Experimental Treatment2 Interventions
Participants receive PEC for 14 weeks, including a 2-week pre-switch period to become familiar with usage. Participants in all arms participate in discussions throughout the trial.
Group III: Arm III (NRT)Active Control2 Interventions
Participants receive NRT (nicotine patches and lozenges) for 14 weeks, including a 2-week pre-switch period to become familiar with usage. Participants in all arms participate in discussions throughout the trial.

Find a Location

Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)NIH
2,543 Previous Clinical Trials
3,247,876 Total Patients Enrolled
Ohio State University Comprehensive Cancer CenterLead Sponsor
334 Previous Clinical Trials
290,108 Total Patients Enrolled
Theodore L Wagener, PhDPrincipal InvestigatorOhio State University Comprehensive Cancer Center
4 Previous Clinical Trials
577 Total Patients Enrolled
~1000 spots leftby Apr 2027
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