Other

Nicotine Containing ECIG with tobacco flavor for Tobacco Addiction

N/A

Recruiting

Research Sponsored by Milton S. Hershey Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Smoke filtered cigarettes/machine-rolled cigarettes (≥5 cigarettes per day) or daily e-cigarette use for past year

Willing to supplement cigarette smoking with ECIG use for 4 weeks or replace e-cigarette with study product for 4 weeks

Must not have

Be younger than 18 years old

Be older than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up2-weeks post-randomization to 4-weeks post-randomization

Awards & highlights

Study Summary

This trial will test if people react to electronic cigarette flavors and nicotine levels the same way they react to drugs, which could help the FDA regulate flavors and smoking cessation.

Eligible Conditions

Tobacco Addiction

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below

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You smoke at least 5 cigarettes per day or use e-cigarettes every day for the past year.

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You are willing to use e-cigarettes instead of regular cigarettes for a period of 4 weeks.

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You are willing to have two brain scans using a machine called fMRI.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Baseline neural flavor cue-reactivity

Changes in neural flavor cue-reactivity

Secondary outcome measures

ECIG craving

ECIG dependence

ECIG liking and satisfaction

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: 18mg/ml Tobacco Flavor ECIGExperimental Treatment1 Intervention

Participants will be provided with an ECIG containing 15mg/ml nicotine concentration and a tobacco flavor.

Group II: 18mg/ml Strawberry Vanilla Flavor ECIGExperimental Treatment1 Intervention

Participants will be provided with an ECIG containing 15mg/ml nicotine concentration and a strawberry vanilla flavor.

Group III: 0mg/ml Tobacco Flavor ECIGPlacebo Group1 Intervention

Participants will be provided with an ECIG containing 0mg/ml nicotine concentration and a tobacco flavor.

Group IV: 0mg/ml Strawberry Vanilla Flavor ECIGPlacebo Group1 Intervention

Participants will be provided with an ECIG containing 0mg/ml nicotine concentration and a strawberry vanilla flavor.

0 / 3Eligibility criteria met

Find a site

Who is running the clinical trial?

Milton S. Hershey Medical CenterLead Sponsor

476 Previous Clinical Trials

2,785,919 Total Patients Enrolled

National Institutes of Health (NIH)NIH

2,611 Previous Clinical Trials

6,663,282 Total Patients Enrolled

Media Library

Nicotine Containing ECIG with Strawberry Vanilla Flavor (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03905928 — N/A

Tobacco Addiction Research Study Groups: 18mg/ml Tobacco Flavor ECIG, 0mg/ml Tobacco Flavor ECIG, 18mg/ml Strawberry Vanilla Flavor ECIG, 0mg/ml Strawberry Vanilla Flavor ECIG

Tobacco Addiction Clinical Trial 2023: Nicotine Containing ECIG with Strawberry Vanilla Flavor Highlights & Side Effects. Trial Name: NCT03905928 — N/A

Nicotine Containing ECIG with Strawberry Vanilla Flavor (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03905928 — N/A

Frequently Asked Questions

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

Who is the ideal cohort to include in this research experiment?

"This medical trial seeks 56 individuals aged 21-60 who suffer from tobacco dependence. Eligible applicants mustn't have attempted a serious quit attempt in the past month and are willing to supplement their cigarette smoking with e-cigarette use for 4 weeks or replace it with study product, attend regular visits over four consecutive weeks, undergo two fMRI scans, read/write English fluently, comprehend & consent to stated procedures, and possess access to computer connected to internet (enabling Zoom video conferencing)."

Answered by AI

Is this research project still open to recruiting new participants?

"As per records from clinicaltrials.gov, this medical trial is presently in the recruitment phase, having been posted on November 4th 2019 and updated as recently as December 1st 2022."

Answered by AI

How much capacity does this clinical trial have for participants?

"Affirmative. The clinical trial details listed on clinicaltrials.gov demonstrate that patient recruitment for this research project is ongoing, having been first launched in November of 2019 and last updated in December 2022. 56 individuals are being sought from a single enrolment centre."

Answered by AI

Is this research endeavor accepting elderly individuals as participants?

"The guidelines for this clinical trial stipulate that suitable candidates should range in age from 21 to 60. Furthermore, there are 4 trials meant exclusively for patients below the legal age of consent and 76 trails devoted solely to those over 65 years old."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Establishing the Effect of Flavor on the Addictive Potential of Electronic Cigarettes

Andrea Hobkirk, PhD 2019. "Establishing the Effect of Flavor on the Addictive Potential of Electronic Cigarettes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03905928.