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Nicotine Reduction for Vaping Addiction

N/A
Recruiting
Led By Wasim Maziak, PhD, MD
Research Sponsored by Florida International University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age of 21-35 years
Be between 18 and 65 years old
Must not have
Report smoking cigarettes regularly (> 5 cigarettes/month in the past year)
Women who are breast-feeding or test positive for pregnancy (by urinalysis at screening)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during the 2 participant visits. blood will be taken 2 times in each electronic cigarette use session: before and after an approximately 60 minutes ad lib use period
Awards & highlights

Summary

This trial will study the effects of nicotine reduction (NR) on young electronic nicotine delivery systems (ENDS) users as a potential regulatory strategy to reduce the addictiveness and use of ENDS.

Who is the study for?
This trial is for healthy adults aged 21-35 who use electronic cigarettes, can attend lab sessions, and have not used e-cigarettes for 12 hours before each visit. Pregnant or breastfeeding women, THC users, those with COVID-19 symptoms or exposure, regular tobacco/nicotine product users in the past year, people with chronic diseases or psychiatric conditions are excluded.Check my eligibility
What is being tested?
The study tests how reducing nicotine levels in electronic cigarettes affects addiction and usage among young adults. Participants will try e-cigarettes with different nicotine concentrations: 0%, 3%, and 5% to see if lower nicotine reduces addictiveness as part of a regulatory strategy.See study design
What are the potential side effects?
While specific side effects aren't listed for this trial, generally vaping can cause throat irritation, coughing, dry mouth and increased thirst; however these vary based on individual reactions to different levels of nicotine.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 21 and 35 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have smoked more than 5 cigarettes a month in the past year.
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I am not pregnant or breastfeeding.
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I have a history of heart disease, blood pressure issues, seizures, or I regularly take prescription medication.
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I am currently experiencing symptoms like cough, fever, or chest pain.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during the 2 participant visits. blood will be taken 2 times in each electronic cigarette use session: before and after an approximately 60 minutes ad lib use period
This trial's timeline: 3 weeks for screening, Varies for treatment, and during the 2 participant visits. blood will be taken 2 times in each electronic cigarette use session: before and after an approximately 60 minutes ad lib use period for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Plasma nicotine
Secondary outcome measures
Carbon monoxide levels
Duke Sensory Questionnaire
Harm perception
+6 more
Other outcome measures
Blood pressure
Heart rate

Trial Design

3Treatment groups
Experimental Treatment
Group I: Electronic cigarette pods (SREC) with 0% nicotine concentrationExperimental Treatment1 Intervention
Participants will complete a lab visit where they will use 0% nicotine electronic cigarette pods ad libitum for up to 60 minutes.
Group II: Electronic cigarette pods (SREC or NJOY) with 5% nicotine concentrationExperimental Treatment1 Intervention
Participants will complete a lab visit where they will use 5% nicotine electronic cigarette pods ad libitum for up to 60 minutes.
Group III: Electronic cigarette pods (NJOY) with 3% nicotine concentrationExperimental Treatment1 Intervention
Participants will complete a lab visit where they will use 3% nicotine electronic cigarette pods ad libitum for up to 60 minutes.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for vaping focus on reducing nicotine dependence and usage through strategies such as nicotine reduction (NR). NR involves gradually lowering the nicotine content in electronic nicotine delivery systems (ENDS) to decrease the user's addiction and overall consumption. This approach aims to reduce the reinforcing effects of nicotine, making it easier for users to quit or reduce their use. Additionally, behavioral interventions, such as counseling and support groups, complement NR by addressing the psychological aspects of addiction. These treatments are crucial for vaping patients as they target both the physical and mental components of nicotine dependence, thereby increasing the likelihood of successful cessation and reducing the health risks associated with prolonged nicotine use.
Promoting smoking abstinence in smokers willing to quit smoking through virtual reality-approach bias retraining: a study protocol for a randomized controlled trial.Electronic Cigarette Cessation in Youth and Young Adults: A Case Series.How do we determine the impact of e-cigarettes on cigarette smoking cessation or reduction? Review and recommendations for answering the research question with scientific rigor.

Find a Location

Who is running the clinical trial?

Florida International UniversityLead Sponsor
100 Previous Clinical Trials
17,435 Total Patients Enrolled
Wasim Maziak, PhD, MDPrincipal InvestigatorFlorida International University
1 Previous Clinical Trials
250 Total Patients Enrolled

Media Library

0% nicotine (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05205382 — N/A
Vaping Research Study Groups: Electronic cigarette pods (SREC) with 0% nicotine concentration, Electronic cigarette pods (SREC or NJOY) with 5% nicotine concentration, Electronic cigarette pods (NJOY) with 3% nicotine concentration
Vaping Clinical Trial 2023: 0% nicotine Highlights & Side Effects. Trial Name: NCT05205382 — N/A
0% nicotine (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05205382 — N/A
~4 spots leftby Aug 2024