Cigarettes with varying nicotine content for Tobacco Dependence

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Tobacco Dependence
Cigarettes with varying nicotine content - Other
Eligibility
18 - 65
Female
What conditions do you have?
Select

Study Summary

This trial will examine whether increasing the availability and appeal of an alternative, non-combusted source of nicotine (e-cigarettes) moderates the effects of altering the nicotine in cigarettes in non-pregnant female cigarette smokers of childbearing age.

Treatment Effectiveness

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: 16 weeks

16 weeks
Number of Cigarettes Smoked Per Day

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

4 Treatment Groups

RC 2 + EC 1
1 of 4
RC 2 + EC 2
1 of 4
RC 1 only
1 of 4
RC 2 only
1 of 4
Experimental Treatment

246 Total Participants · 4 Treatment Groups

Primary Treatment: Cigarettes with varying nicotine content · No Placebo Group · Phase 2

RC 2 + EC 1Experimental Group · 2 Interventions: Cigarettes with varying nicotine content, E-Cigarettes · Intervention Types: Other, Other
RC 2 + EC 2Experimental Group · 2 Interventions: Cigarettes with varying nicotine content, E-Cigarettes · Intervention Types: Other, Other
RC 1 only
Other
Experimental Group · 1 Intervention: Cigarettes with varying nicotine content · Intervention Types: Other
RC 2 only
Other
Experimental Group · 1 Intervention: Cigarettes with varying nicotine content · Intervention Types: Other

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 16 weeks

Who is running the clinical trial?

Johns Hopkins UniversityOTHER
2,055 Previous Clinical Trials
30,974,735 Total Patients Enrolled
3 Trials studying Tobacco Dependence
989 Patients Enrolled for Tobacco Dependence
National Institute on Drug Abuse (NIDA)NIH
2,225 Previous Clinical Trials
5,612,681 Total Patients Enrolled
19 Trials studying Tobacco Dependence
5,254 Patients Enrolled for Tobacco Dependence
Food and Drug Administration (FDA)FED
151 Previous Clinical Trials
954,627 Total Patients Enrolled
1 Trials studying Tobacco Dependence
828 Patients Enrolled for Tobacco Dependence
University of VermontLead Sponsor
253 Previous Clinical Trials
3,741,150 Total Patients Enrolled
Stephen T. Higgins, Ph.D.Principal Investigator - University of Vermont
University of Vermont
2 Previous Clinical Trials
564 Total Patients Enrolled

Eligibility Criteria

Age 18 - 65 · Female Participants · 2 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are female.
You are between 21 and 44 years old.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 3rd, 2021

Last Reviewed: October 2nd, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.