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Nicotine (electronic cigarette) for Smoking/Cigarette Smoking

N/A
Waitlist Available
Led By Jasjit S Ahluwalia, MD
Research Sponsored by Brown University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 21 (inclusive) years of age or greater
Exhaled CO ≥ 6 ppm at baseline
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 6 months
Awards & highlights

Study Summary

This trial will enroll 45 low-SES smokers and will provide them with either 8 weeks of complimentary e-cigarettes or nicotine pouches, or no intervention. The study will measure indicators of tobacco use and harm at baseline and Week 8.

Eligible Conditions
  • Smoking/Cigarette Smoking
  • Nicotine Addiction

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You have smoked cigarettes in the past 6 months.
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You have a household income of less than $25,000 per year.
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You are willing to substitute combustible cigarettes for EC or NPs.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in cigarette dependence from baseline to week 8
Change in cigarettes per day from baseline to week 8
Cigarette abstinence at week 8
Secondary outcome measures
Change in 8-isoprostane from baseline to week 8
Change in Carbon monoxide from baseline to week 8
Change in NNAL from baseline to week 8
+2 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Nicotine PouchExperimental Treatment1 Intervention
Participants in this experimental condition will be provided with nicotine pouches.
Group II: Electronic CigaretteExperimental Treatment1 Intervention
Participants in this experimental condition will be provided with a 4th generation electronic cigarette device and disposable cartridges.
Group III: Smoking As UsualActive Control1 Intervention
Participants in this assessment-only condition will continue smoking as usual.

Find a Location

Who is running the clinical trial?

Brown UniversityLead Sponsor
454 Previous Clinical Trials
562,720 Total Patients Enrolled
Jasjit S Ahluwalia, MDPrincipal InvestigatorBrown University

Frequently Asked Questions

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

Is it possible to enroll in this medical experiment at the present time?

"Per the information available on clinicaltrials.gov, this trial is actively searching for participants and has been since March 23rd 2022. The last time data was updated was April 11th 2022."

Answered by AI

What is the uppermost capacity of participants in this research endeavor?

"Yes, clinicaltrials.gov reveals that this trail is actively searching for participants to enroll in the study. The trial was first announced on March 23rd 2022 and has since been revised on April 11th of the same year. 45 patients are needed at a single medical site."

Answered by AI

What are the ultimate goals of this research endeavor?

"The primary objective of this trial, monitored over an 8-week period is to assess cigarette abstinence. Secondary outcomes include the feasibility and acceptance rate (measured by the proportion of eligible participants who take part in the study) as well as retention rates, barriers to substitution identified via exit interviews, changes in exhaled carbon monoxide levels measured with a Smokerlyzer device between baseline and week 8, and changes in NNAL/creatinine cotinine ratio likewise assessed through urine samples."

Answered by AI

Who else is applying?

What state do they live in?
California
Indiana
New Jersey
Other
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
~15 spots leftby Apr 2025