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Low Nicotine Cigarettes + E-Cigarettes for Tobacco Use Disorder

Phase 2
Waitlist Available
Led By Stephen T. Higgins, Ph.D.
Research Sponsored by University of Vermont
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks
Awards & highlights

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.

Who is the study for?
This trial is for female daily smokers aged 21-44 with a high school education or less. It's focused on those who may become pregnant, to study the impact of low nicotine cigarettes and e-cigarettes. Men, individuals under 21 or over 44 are not eligible.Check my eligibility
What is being tested?
The study tests the effects of two types of research cigarettes—one with normal nicotine levels and one reduced—and two e-cigarette conditions differing in flavor choices. Participants will use these products exclusively for 16 weeks to see how they affect smoking habits and health.See study design
What are the potential side effects?
Potential side effects aren't specified but could include typical risks associated with nicotine products such as addiction, withdrawal symptoms when stopping, increased heart rate and blood pressure, respiratory issues, and potential harm during pregnancy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Cigarettes Smoked Per Day

Trial Design

4Treatment groups
Experimental Treatment
Group I: RC 2 onlyExperimental Treatment1 Intervention
Research Cigarettes #2
Group II: RC 2 + EC 2Experimental Treatment2 Interventions
Research Cigarettes #2 plus E-cigarettes #2
Group III: RC 2 + EC 1Experimental Treatment2 Interventions
Research Cigarettes #2 plus E-cigarettes #1
Group IV: RC 1 onlyExperimental Treatment1 Intervention
Research cigarettes #1

Find a Location

Who is running the clinical trial?

University of VermontLead Sponsor
266 Previous Clinical Trials
3,743,445 Total Patients Enrolled
14 Trials studying Tobacco Use Disorder
5,504 Patients Enrolled for Tobacco Use Disorder
National Institute on Drug Abuse (NIDA)NIH
2,467 Previous Clinical Trials
2,618,877 Total Patients Enrolled
271 Trials studying Tobacco Use Disorder
48,821 Patients Enrolled for Tobacco Use Disorder
Johns Hopkins UniversityOTHER
2,260 Previous Clinical Trials
14,820,534 Total Patients Enrolled
17 Trials studying Tobacco Use Disorder
4,103 Patients Enrolled for Tobacco Use Disorder

Media Library

Low Nicotine Content Cigarettes (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04092387 — Phase 2
Tobacco Use Disorder Research Study Groups: RC 2 + EC 2, RC 1 only, RC 2 only, RC 2 + EC 1
Tobacco Use Disorder Clinical Trial 2023: Low Nicotine Content Cigarettes Highlights & Side Effects. Trial Name: NCT04092387 — Phase 2
Low Nicotine Content Cigarettes (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04092387 — Phase 2

Frequently Asked Questions

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

How many participants have enlisted to partake in this investigation?

"Affirmative. According to the public data on clinicaltrials.gov, this medical trial is actively trying to recruit individuals for its research; having been first posted on September 18th 2019 and last updated February 22nd 2021. In total 246 participants are needed across two sites."

Answered by AI

Has the FDA sanctioned cigarettes with fluctuating nicotine levels?

"The safety of cigarettes with varying nicotine content was assessed to be a 2 according to Power, as the clinical trial is in Phase 2 and there are data supporting its security, but none advocating for its efficacy."

Answered by AI

Are there vacancies still open for participants in this investigation?

"Affirmative. According to information provided on clinicaltrials.gov, this clinical trial was first posted in September of 2019 and is currently recruiting participants with the goal of enrolling 246 patients over two sites."

Answered by AI

Does this trial extend to individuals of a younger demographic?

"This clinical trial has established age limits for enrollment, with the minimum being 18 and the maximum 44."

Answered by AI

Can I meet the requirements to partake in this medical research project?

"The requirements to become a participant in this clinical trial include having tobacco dependence and be an adult between the ages of 18-44. Aspiring participants should note that 246 patients are needed for the study."

Answered by AI

Who else is applying?

What state do they live in?
Maryland
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Low Nicotine Content Cigarettes in Vulnerable Populations: Women of Reproductive Age
Stephen T. Higgins, PhD 2019. "Low Nicotine Content Cigarettes in Vulnerable Populations: Women of Reproductive Age". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04092387.
~44 spots leftby Apr 2025
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