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Nicotine Replacement for Cigarette Smokers

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Ohio State University Comprehensive Cancer Center, Columbus, OHCigarette Smokers+1 MoreNicotine Replacement - Drug
Eligibility
21 - 52
All Sexes
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Study Summary

This trial is studying how smoking e-cigarettes affects the lungs by looking at changes in the DNA of lung cells.

Eligible Conditions
  • Cigarette Smokers
  • Everyday Smoker

Treatment Effectiveness

Effectiveness Progress

1 of 3

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1
Nicotine Replacement
1
Nicotine Replacement
1
Counseling + Standardized Research E-cigarettes (SREC)

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: Baseline to day 71

Baseline to day 71
Body Weight Changes
Day 71
Changes in deoxyribonucleic acid (DNA) gene methylation
Changes in fractional exhaled nitric oxide (FeNO) levels
Changes in messenger (m) ribonucleic acid (RNA) and microRNA (miRNA) gene expression analyzed using sequencing
Changes in the microbiome in BAL cells and saliva
Changes in untargeted metabolomics using mass spectrometry

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
Nicotine Replacement
2
Nicotine Replacement
1
Counseling + Standardized Research E-cigarettes (SREC)

Trial Design

5 Treatment Groups

Group I (usual cigarette brand)
1 of 5
Group V (NRT)
1 of 5
Group IV (usual cigarette brand, nicotine-containing SREC)
1 of 5
Group II (SREC with nicotine)
1 of 5
Group III (SREC without nicotine)
1 of 5

Active Control

Experimental Treatment

239 Total Participants · 5 Treatment Groups

Primary Treatment: Nicotine Replacement · No Placebo Group · Phase < 1

Group V (NRT)Experimental Group · 4 Interventions: Bronchoscopy with Bronchoalveolar Lavage, Laboratory Biomarker Analysis, Nicotine Replacement, Questionnaire Administration · Intervention Types: Procedure, Other, Drug, Other
Group IV (usual cigarette brand, nicotine-containing SREC)Experimental Group · 5 Interventions: Bronchoscopy with Bronchoalveolar Lavage, Cigarette, Electronic Cigarette, Laboratory Biomarker Analysis, Questionnaire Administration · Intervention Types: Procedure, Drug, Other, Other, Other
Group II (SREC with nicotine)Experimental Group · 4 Interventions: Bronchoscopy with Bronchoalveolar Lavage, Electronic Cigarette, Laboratory Biomarker Analysis, Questionnaire Administration · Intervention Types: Procedure, Other, Other, Other
Group III (SREC without nicotine)Experimental Group · 4 Interventions: Bronchoscopy with Bronchoalveolar Lavage, Electronic Cigarette, Laboratory Biomarker Analysis, Questionnaire Administration · Intervention Types: Procedure, Other, Other, Other
Group I (usual cigarette brand)ActiveComparator Group · 4 Interventions: Bronchoscopy with Bronchoalveolar Lavage, Cigarette, Laboratory Biomarker Analysis, Questionnaire Administration · Intervention Types: Procedure, Drug, Other, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cigarette
2017
Completed Phase 1
~260

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to day 71

Who is running the clinical trial?

Ohio State University Comprehensive Cancer CenterLead Sponsor
290 Previous Clinical Trials
285,900 Total Patients Enrolled
1 Trials studying Cigarette Smokers
2,994 Patients Enrolled for Cigarette Smokers
National Institute on Drug Abuse (NIDA)NIH
2,272 Previous Clinical Trials
2,033,670 Total Patients Enrolled
3 Trials studying Cigarette Smokers
230 Patients Enrolled for Cigarette Smokers
Peter Shields, MDPrincipal InvestigatorOhio State University Comprehensive Cancer Center
2 Previous Clinical Trials
3,202 Total Patients Enrolled
1 Trials studying Cigarette Smokers
2,994 Patients Enrolled for Cigarette Smokers

Eligibility Criteria

Age 21 - 52 · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You smoke at least 5 cigarettes a day for a year or more.
References

Frequently Asked Questions

Are there still open enrollment opportunities for this research study?

"Affirmative. Clinicaltrials.gov reveals that this medical experiment, which was launched on September 17th 2018, is presently recruiting volunteers. A total of 239 participants are needed from one location." - Anonymous Online Contributor

Unverified Answer

How many participants have signed up to take part in this trial?

"Affirmative. According to records hosted on clinicaltrials.gov, this medical experiment was published on September 17th 2018 and is actively seeking participants with an updated post from August 4th 2022. The trial requires 239 volunteers across a single site for completion." - Anonymous Online Contributor

Unverified Answer

Does this research involve participants aged 35 or older?

"Patients aged between 21 and 45 are eligible to enroll in this clinical trial." - Anonymous Online Contributor

Unverified Answer

Have past research initiatives utilized Nicotine Replacement for their studies?

"Currently, 71 trials are underway to evaluate Nicotine Replacement Therapy. Five of these studies have entered their third phase and the majority of them can be found in Augusta, Georgia. However, 204 different medical sites around the world are conducting research into this intervention." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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