E-cigarettes for Cigarette Addiction

Overseen By Jennifer Pearson, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Nevada, Reno

Disqualifiers: Pregnancy, Breast-feeding, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if e-cigarettes can help individuals reduce or quit smoking during substance use disorder treatment. Participants will receive e-cigarettes and instructions on transitioning from traditional cigarettes. The trial requires using e-cigarettes for two weeks and reporting daily smoking habits and mood through text message surveys. Ideal candidates are those currently in outpatient treatment at the Mathewson Institute, who smoke daily and are interested in switching to e-cigarettes. As an unphased trial, this study provides a unique opportunity to explore a new method for smoking cessation while receiving support in a treatment setting.

Do I have to stop taking my current medications to join the trial?

The trial protocol does not specify whether you need to stop taking your current medications. It seems focused on smoking and e-cigarette use, so you may not need to change your medication routine.

What prior data suggests that e-cigarettes are safe for smoking harm reduction?

Studies have shown that e-cigarettes might be less harmful than regular cigarettes, especially when individuals switch from smoking to using e-cigarettes. Research indicates that e-cigarettes can help people reduce smoking regular cigarettes or quit entirely.

Ongoing research aims to understand the safety of e-cigarettes. While not without risks, they might be a safer choice compared to traditional cigarettes, which is important for those seeking to reduce smoking-related harm.

For those considering joining a trial with e-cigarettes, it's important to know they are being tested for safety and effectiveness. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for cigarette addiction, which often rely on nicotine replacement therapies like patches, gum, or lozenges, the NIDA Standardized Research Electronic Cigarette offers a new approach by mimicking the act of smoking with an e-cigarette device. This method leverages the familiar hand-to-mouth motion and inhalation experience, potentially making it easier for smokers to transition away from traditional cigarettes. Researchers are particularly excited about the tailored instructions that accompany the e-cigarette, which could enhance user engagement and success in quitting smoking by providing a more personalized quitting experience.

What evidence suggests that e-cigarettes are effective for cigarette addiction?

Research has shown that e-cigarettes can help people quit or reduce smoking regular cigarettes. A major U.S. study found that e-cigarettes effectively aid adult smokers in cutting down or quitting. This is important because smoking less can lower health risks linked to regular cigarette use. In this trial, participants will receive the NIDA Standardized Research Electronic Cigarette, designed to help achieve these goals. Additionally, research indicates that e-cigarettes are popular among those trying to quit smoking, suggesting they could be a helpful tool for those looking to stop. ^{2 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for adults over 21 who are currently in outpatient treatment for substance use disorder at the Mathewson Institute, smoke daily, and are interested in switching from cigarettes to e-cigarettes. Participants must have a cellphone with unlimited texts, use texting weekly, and understand English well enough to follow the study.

Inclusion Criteria

Uses text messages at least once a week

I have a cellphone with unlimited texting.

Self-reports daily smoking

Exclusion Criteria

Have used an e-cigarette to quit smoking in the past month

Are currently pregnant or breast-feeding.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Baseline Assessment

Participants report their usual smoking to establish baseline behavior

1 week

Daily surveys (virtual)

Treatment

Participants receive e-cigarettes and tailored instructions to switch, with daily reporting of cigarette and e-cigarette use

2 weeks

Daily surveys (virtual)

Follow-up

Participants are monitored for smoking reduction and complete switching to e-cigarettes

1 week

1 interview (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• NIDA Standardized Research Electronic Cigarette

Trial Overview

The study tests how feasible it is to add a smoking harm reduction program that provides e-cigarettes into existing substance abuse treatments. It involves three weeks of surveys via text messages to assess acceptability and gather initial data on effectiveness.

How Is the Trial Designed?

Group I: E-cigarette arm Experimental Treatment 1 Intervention

Participants will receive the commercially available NJOY ACE e-cigarette, nicotine pods (2 of each available flavor, for a total of 4 pods), and tailored instructions to switch. Participants will use the ACE ad libitum for 14 days, reporting their cigarette use, e-cigarette use, mood, and nicotine crazing every day via text message surveys.

Who Is Running the Clinical Trial?

University of Nevada, Reno

Lead Sponsor

Trials

34

Recruited

20,200+

Published Research Related to This Trial

This study outlines a randomized controlled trial involving 657 participants in Auckland, New Zealand, to evaluate the efficacy and safety of nicotine e-cigarettes compared to nicotine patches and placebo e-cigarettes for smoking cessation.

The primary outcome will be the rate of biochemically verified continuous abstinence from smoking at six months, which will provide crucial data on whether e-cigarettes can serve as effective smoking cessation aids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study protocol for a randomised controlled trial of electronic cigarettes versus nicotine patch for smoking cessation. Bullen, C., Williman, J., Howe, C., et al.[2022]

In a 12-month study involving 300 smokers not intending to quit, the use of e-cigarettes, regardless of nicotine content, led to significant reductions in cigarette consumption and some enduring abstinence from tobacco, with 22.3% reducing smoking at week 12 and 10.7% achieving complete abstinence.

The study found that e-cigarette use was associated with a decrease in adverse events and withdrawal symptoms, indicating that e-cigarettes may be a safer alternative for smokers looking to reduce their tobacco use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

EffiCiency and Safety of an eLectronic cigAreTte (ECLAT) as tobacco cigarettes substitute: a prospective 12-month randomized control design study. Caponnetto, P., Campagna, D., Cibella, F., et al.[2023]

In a study of 959 participants, e-cigarette users (e-smokers) had a significantly higher rate of sustained tobacco smoking abstinence at 12 months (61.9%) compared to tobacco smokers (20.6%) and dual smokers (22.0%), indicating that e-cigarettes may be an effective tool for smoking cessation.

Using e-cigarettes alongside tobacco smoking did not improve the chances of quitting or reduce the number of tobacco cigarettes smoked, suggesting that e-cigarettes are more beneficial when used alone for those trying to quit.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electronic Cigarettes Efficacy and Safety at 12 Months: Cohort Study. Manzoli, L., Flacco, ME., Fiore, M., et al.[2018]

Recent reviews and studies (over 50 published mainly in 2022 and 2023) highlight significant health risks associated with e-cigarettes, particularly affecting the respiratory, neurological, and cardiovascular systems.

There is a strong call for regulatory action to limit e-cigarette use, as the evidence suggests substantial health risks that could impact the general population, especially since their use for smoking cessation is not widely endorsed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electronic Cigarette Harms: Aggregate Evidence Shows Damage to Biological Systems. Hamann, SL., Kungskulniti, N., Charoenca, N., et al.[2023]

In a study of 150 participants, e-cigarettes were found to be as effective as nicotine gum for smoking cessation, with no significant differences in overall abstinence rates.

E-cigarettes were associated with a higher proportion of participants showing smoking reduction at 24 weeks and had fewer adverse events compared to nicotine gum, suggesting they may be a safer alternative for nicotine replacement therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Electronic Cigarettes on Smoking Reduction and Cessation in Korean Male Smokers: A Randomized Controlled Study. Lee, SH., Ahn, SH., Cheong, YS.[2020]

Electronic cigarettes (ECIGs) can vary widely in their nicotine delivery, with some delivering very little and others exceeding the nicotine levels of traditional cigarettes, which complicates their use as a smoking cessation tool.

The variability in nicotine content poses risks for both smokers trying to switch to ECIGs and non-smokers who may start using them, potentially leading to nicotine dependence and increased public health concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electronic cigarettes and nicotine dependence: evolving products, evolving problems. Cobb, CO., Hendricks, PS., Eissenberg, T.[2018]

Electronic cigarettes are marketed as safe alternatives to traditional tobacco products, but there are growing concerns about their potential negative health impacts.

There is a call for regulatory measures on the manufacturing and marketing of e-cigarettes, as well as further research to better understand their health effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electronic cigarettes: health risks and workplace policy. Phillips, JA.[2017]

A meta-analysis of 18 studies involving 3756 papers found no significant difference in the rates of adverse events (AEs) like cough, oral irritation, and nausea between nicotine electronic cigarettes (ECs) and nicotine replacement therapies (NRTs).

The similar incidence of AEs suggests that the preference for nicotine ECs over NRTs is not driven by differences in adverse effects, indicating a need for further research to explore other factors influencing user choices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Common adverse events of electronic cigarettes compared with traditional nicotine replacement therapies: A systematic review and meta-analysis. Anandan, AS., Leung, J., Chan, GCK., et al.[2023]

The National Institute on Drug Abuse (NIDA) has introduced a standardized e-cigarette device for research, aiming to investigate the health impacts of e-cig use, particularly its carcinogenic potential in youth who have never smoked.

Chemical analyses show that e-cigarettes contain carcinogens similar to those found in traditional cigarettes, highlighting the need for research to compare the cancer risks of e-cigarettes and conventional smoking, especially among young users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An opportune and unique research to evaluate the public health impact of electronic cigarettes. Besaratinia, A., Tommasi, S.[2019]

The study found that a 36 mg/mL nicotine e-cigarette had a higher potential for abuse compared to an FDA-approved nicotine inhaler, but lower than traditional cigarettes, indicating a moderate risk for addiction among smokers.

Participants reported that the 36 mg/mL e-cigarette was more effective in reducing nicotine withdrawal symptoms than a 0 mg/mL version, suggesting that e-cigs can help manage cravings, but they still pose a risk of abuse compared to other nicotine delivery methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Abuse liability assessment of an electronic cigarette in combustible cigarette smokers. Maloney, SF., Breland, A., Soule, EK., et al.[2020]

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