What side effects are associated with this type of intervention?

Common treatments for vaping cessation, particularly those involving nicotine reduction strategies, include nicotine replacement therapies (NRT) such as nicotine patches and metered dose inhalers. These treatments can cause side effects like mild coughing, nasal irritation, and burning sensations. Varenicline, another common treatment, may lead to nausea, vomiting, and mild psychiatric symptoms. Combination therapies, such as varenicline with NRT, have shown adverse events like dizziness and anxiety. Overall, while these treatments can be effective, they often come with a range of mild to moderate side effects.

What prior FDA approvals exist?

As of now, there are no specific FDA-approved treatments exclusively for vaping cessation. However, treatments approved for smoking cessation, such as nicotine replacement therapy (NRT), bupropion, and varenicline, may be considered for vaping cessation. These treatments aim to reduce nicotine dependence and usage, similar to the nicotine reduction strategy being studied in trials. The focus on lowering nicotine doses to reduce dependence and usage aligns with the broader approach of these pharmacotherapies.

What other types of research exist?

Promising alternatives to nicotine reduction for vaping patients include cognitive behavioral therapy (CBT), digital interventions like mobile apps and online support, and pharmacological treatments such as varenicline, bupropion, and nicotine replacement therapies. Combining behavioral support with pharmacotherapy is also an effective strategy.

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Other

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

No Placebo-Only Group

Summary

This trial aims to see if reducing nicotine in e-cigarettes can make them less addictive for young users. Researchers will test different levels of nicotine reduction to find out if it helps decrease usage and dependence. The study focuses on young people because they are increasingly using e-cigarettes and are at high risk of addiction.

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.

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.

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 weeks3 visits

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

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Plasma nicotine

Secondary study objectives

Carbon monoxide levels

Duke Sensory Questionnaire

Harm perception

+6 more

Other study objectives

Blood pressure

Heart rate

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 5Eligibility criteria met

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.