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Nicotine Patch for E-Cigarette Withdrawal

Q: Might I be eligible to partake in this experiment?

Eligible candidates for this clinical trial must be between 21 and 55 years old, with a documented history of e-cigarette use. Recruitment is estimated to include 150 individuals.

Q: Are geriatric populations being included in the enrollment process of this trial?

The criteria for participating in this medical trial stipulates that patients must fall between the ages of 21 and 55. There are 13 available trials aimed at people below 18 years old, while 17 are designed to accommodate those aged 65 or higher.

Q: Is this research endeavor actively searching for participants?

According to clinicaltrials.gov, this medical study is no longer accepting new participants. Initially posted on November 1st 2023 and last edited September 28th 2023, it has concluded its recruitment process; however, 41 other trials are actively recruiting patients at the moment.

Phase < 1

Recruiting

Led By Justin Strickland, Ph.D.

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

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

Must have

21-55 years old

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, every 4 hours up to 16 hours

Awards & highlights

Study Summary

This trial aims to study how quitting e-cigarettes affects people & the role of nicotine in the withdrawal symptoms that follow.

Who is the study for?

This trial is for adults aged 21-55 who use e-cigarettes daily, have a mild or greater dependence on nicotine, and are in good health. Participants must not be using other tobacco products or cessation aids, have no major medical or psychiatric conditions that could affect their safety, and should not be pregnant.Check my eligibility

What is being tested?

The study aims to understand withdrawal symptoms in exclusive e-cigarette users by comparing the effects of a transdermal nicotine patch versus a placebo patch during an abstinence period.See study design

What are the potential side effects?

Potential side effects may include skin irritation from the patch application site. Since it involves nicotine replacement therapy, some participants might experience dizziness, headache, nausea, or sleep disturbances.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am between 21 and 55 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, every 4 hours up to 16 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, every 4 hours up to 16 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, every 4 hours up to 16 hours 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 Conners' Continuous Performance Task (CPT)

Change in Hughes-Hatsukami Withdrawal Scale

Change in Memory as assessed by the N-Back

+5 more

Secondary outcome measures

Change in E-Cigarette Demand Elasticity

Change in E-Cigarette Demand Intensity

Return to Use

Side effects data

From 2009 Phase 4 trial • 60 Patients • NCT00383747

Nausea

allergic reaction to peanuts

deterioration in mental state

Vomiting

100%

80%

60%

40%

20%

Study treatment Arm

Non Smokers With Schizophrenia

Controls

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Transdermal Nicotine PatchExperimental Treatment1 Intervention

Participants assigned to this condition will receive a blinded nicotine patch and will wear the patch on their upper arm, per the manufacturer's instructions.

Group II: No PatchActive Control1 Intervention

Participants assigned to this condition will not receive a patch.

Group III: Transdermal Placebo PatchPlacebo Group1 Intervention

Participants assigned to this placebo nicotine patch condition will receive a blinded patch containing 0mg of nicotine, and will wear the patch on their upper arm, per the manufacturer's instructions.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Transdermal Nicotine Patch

2015

Completed Phase 4

~1080

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor

2,266 Previous Clinical Trials

14,837,347 Total Patients Enrolled

National Institute on Drug Abuse (NIDA)NIH

2,470 Previous Clinical Trials

2,619,581 Total Patients Enrolled

Justin Strickland, Ph.D.Principal InvestigatorJohns Hopkins University

1 Previous Clinical Trials

20 Total Patients Enrolled

Frequently Asked Questions

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

Might I be eligible to partake in this experiment?

"Eligible candidates for this clinical trial must be between 21 and 55 years old, with a documented history of e-cigarette use. Recruitment is estimated to include 150 individuals."

Answered by AI

Are geriatric populations being included in the enrollment process of this trial?

"The criteria for participating in this medical trial stipulates that patients must fall between the ages of 21 and 55. There are 13 available trials aimed at people below 18 years old, while 17 are designed to accommodate those aged 65 or higher."

Answered by AI

Is this research endeavor actively searching for participants?

"According to clinicaltrials.gov, this medical study is no longer accepting new participants. Initially posted on November 1st 2023 and last edited September 28th 2023, it has concluded its recruitment process; however, 41 other trials are actively recruiting patients at the moment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Evaluation of the Electronic Cigarette Withdrawal Syndrome

2023. "Evaluation of the Electronic Cigarette Withdrawal Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06066996.