Tobacco Use Treatment for Smoking Cessation

Overseen By Shelbie Wooten, MPH

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Children's Mercy Hospital Kansas City

Disqualifiers: Severe psychiatric illness, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 3 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help young people stop vaping and smoking by testing a new treatment program. Participants will either receive an informational brochure or join a behavioral health intervention that includes personalized support. Those who have used e-cigarettes in the last 30 days and are admitted to a hospital might be a good fit. The trial seeks to find effective ways to support quitting smoking and vaping among adolescents and young adults. As an unphased trial, this study offers a unique opportunity to contribute to innovative strategies for quitting smoking and vaping.

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.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this intervention is safe for adolescents and young adults?

Research shows that e-cigarettes can help people quit smoking more effectively than some other methods, suggesting they might be a useful tool for smoking cessation. However, safety concerns exist. Known risks of e-cigarette use include nicotine addiction and potential lung injuries from vaping.

Studies have found that most smoking cessation treatments are generally safe. However, due to incomplete long-term safety data on e-cigarettes, awareness of these potential risks is crucial.

The trial's treatment includes a behavioral health intervention, which typically involves supportive conversations. This component does not carry the same safety concerns as trying a new drug. Therefore, safety concerns primarily relate to the e-cigarettes used in the treatment, not the supportive conversations. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a novel approach to smoking cessation by integrating e-cigarettes with a behavioral health intervention supported by computerized decision support. Unlike traditional methods like nicotine patches or gum, this intervention combines digital tools to tailor the behavioral support to each individual, potentially making it more effective. The use of e-cigarettes as a transition tool could also offer a more gradual and personalized way to reduce tobacco dependence. This unique combination aims to address both the physical and psychological aspects of smoking addiction, offering hope for improved quit rates.

What evidence suggests that this E-cigarette & Tobacco Use Treatment Intervention is effective for smoking cessation?

Research shows that e-cigarettes can help people quit smoking. One study found that e-cigarettes worked as well as varenicline, a common medication for quitting smoking, and were more effective than nicotine gum. Another study found that combining e-cigarettes with counseling helped more people quit smoking than counseling alone. In this trial, participants in the intervention arm will receive a behavioral health intervention supported by computerized decision support, which may include e-cigarettes as part of the tobacco use treatment. E-cigarettes and other nicotine delivery methods proved more effective than no treatment in helping people stop smoking. Overall, these findings suggest e-cigarettes can be a helpful tool for quitting smoking and vaping. ^{1 2 6 7 8}

Who Is on the Research Team?

Abbey Masonbrink, MD

Principal Investigator

Children's Hospital Los Angeles

Are You a Good Fit for This Trial?

This trial is for young people aged between 14 and 21 who are in the hospital, have used e-cigarettes in the past month, and can speak/read English. It's not suitable for those too ill to participate, with severe cognitive impairments or psychiatric conditions.

Inclusion Criteria

Parent/guardian agrees to leave the room

I am currently admitted to a hospital.

Screens positive for past 30 day e-cigarette use

Exclusion Criteria

I am not comfortable with English.

Severe psychiatric illness

I am either younger than 14 or older than 21.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a behavioral health intervention supported by computerized decision support

3 months

Inpatient visits during hospitalization

Follow-up

Participants are monitored for self-reported 30-day abstinence with biochemical verification

3 months

What Are the Treatments Tested in This Trial?

Interventions

• E-cigarette & Tobacco Use Treatment Intervention

Trial Overview The study aims to develop and test a program designed to help adolescents quit vaping and smoking while they're admitted in the hospital. The effectiveness of this new tobacco use treatment intervention will be evaluated.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Participants will complete the baseline survey, receive a behavioral health intervention supported by computerized decision support, and take an exit survey

Group II: Control Active Control 1 Intervention

Participants will complete the baseline survey and receive an informational brochure

E-cigarette & Tobacco Use Treatment Intervention is already approved in United States, European Union for the following indications:

Approved in United States as Nicotine Replacement Therapy (NRT) for:

• Tobacco smoking cessation

Approved in United States as Varenicline for:

• Tobacco smoking cessation

Approved in United States as Bupropion for:

• Tobacco smoking cessation

Approved in European Union as Nicotine Replacement Therapy (NRT) for:

• Tobacco smoking cessation

Approved in European Union as Varenicline for:

• Tobacco smoking cessation

Approved in European Union as Bupropion for:

• Tobacco smoking cessation

Who Is Running the Clinical Trial?

Children's Mercy Hospital Kansas City

Lead Sponsor

Trials

261

Recruited

941,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Published Research Related to This Trial

Varenicline (27.6%) and combination nicotine replacement therapy (31.5%) were found to be the most effective treatments for achieving smoking cessation, significantly outperforming both bupropion (19.1%) and nicotine replacement therapy alone (17.6%).

All three first-line smoking cessation treatments (NRT, bupropion, and varenicline) were safe, as none were associated with an increased rate of serious adverse events compared to placebo (10.6%).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacological treatments for smoking cessation. Cahill, K., Stevens, S., Lancaster, T.[2022]

In a study involving 4092 participants with psychiatric disorders, varenicline, bupropion, and nicotine patches were found to be well tolerated and effective for smoking cessation, with no significant increase in neuropsychiatric adverse events compared to placebo.

Varenicline demonstrated superior continuous abstinence rates compared to bupropion, nicotine patches, and placebo, indicating its effectiveness across various psychiatric diagnoses without varying efficacy based on the type of disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuropsychiatric Safety and Efficacy of Varenicline, Bupropion, and Nicotine Patch in Smokers With Psychotic, Anxiety, and Mood Disorders in the EAGLES Trial. Evins, AE., Benowitz, NL., West, R., et al.[2020]

Varenicline, especially in combination with nicotine replacement therapy (NRT), is the most effective treatment for achieving sustained tobacco abstinence, with an odds ratio of 5.75 for the combination therapy compared to placebo.

Bupropion at standard doses is associated with a higher risk of serious adverse events compared to placebo, while most other cessation therapies, including varenicline and NRT, do not show significant safety concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative clinical effectiveness and safety of tobacco cessation pharmacotherapies and electronic cigarettes: a systematic review and network meta-analysis of randomized controlled trials. Thomas, KH., Dalili, MN., López-López, JA., et al.[2022]

In a study of 11,968 participants in Taiwan, varenicline was found to be more effective than nicotine replacement therapy (NRT) patch in achieving smoking abstinence, with higher odds ratios for 7-day, 1-month, and 6-month point-prevalence rates.

Varenicline showed significant benefits for both women and smokers with light to moderate nicotine dependence, indicating its effectiveness across different demographics and levels of nicotine addiction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative Effectiveness of Smoking Cessation Medications: A National Prospective Cohort From Taiwan. Chang, PY., Lo, PC., Chang, HC., et al.[2018]

In a 52-week study involving 746 participants, varenicline was found to be significantly more effective than transdermal nicotine replacement therapy (NRT) for smoking cessation, with a continuous abstinence rate of 55.9% compared to 43.2% for NRT during the last 4 weeks of treatment.

Varenicline also led to significantly lower levels of craving, withdrawal symptoms, and smoking satisfaction compared to NRT, although it had a higher incidence of nausea as a side effect (37.2% for varenicline vs. 9.7% for NRT).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Varenicline versus transdermal nicotine patch for smoking cessation: results from a randomised open-label trial. Aubin, HJ., Bobak, A., Britton, JR., et al.[2022]

Varenicline is the most effective smoking cessation treatment among nicotine replacement therapies and bupropion, with an odds ratio of 3.09 compared to placebo, indicating its strong efficacy in helping people quit smoking.

Bupropion offers unique benefits for cancer patients, such as increased energy and a lower risk of nausea and weight gain, making it a suitable option for those trying to quit smoking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacotherapy for tobacco cessation: nicotine agonists, antagonists, and partial agonists. Karam-Hage, M., Cinciripini, PM.[2021]

In a study involving 2626 clients from NHS Stop Smoking Services, nicotine replacement therapy (NRT) showed a higher short-term abstinence rate (42%) compared to bupropion (34%), which contradicts findings from previous randomized controlled trials.

The easier access to NRT in clinical settings may explain its greater effectiveness, suggesting that practical implementation issues can significantly impact the success of smoking cessation medications in real-world healthcare environments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do implementation issues influence the effectiveness of medications? The case of nicotine replacement therapy and bupropion in UK Stop Smoking Services. McEwen, A., West, R.[2021]

In a large analysis of 167,487 treatment episodes, varenicline was found to have a higher smoking abstinence rate (43.5%) compared to combination nicotine replacement therapy (NRT) (36.9%), indicating it may be more effective for helping smokers quit.

When accounting for various factors, varenicline still showed a small but statistically significant advantage over combination NRT, with an odds ratio of 1.080, suggesting that it could be a preferred option in smoking cessation treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the effectiveness of varenicline and combination nicotine replacement therapy for smoking cessation in clinical practice. Brose, LS., West, R., Stapleton, JA.[2021]

Combining pharmacotherapy with nonpharmacological interventions is the most effective way to help smokers quit, highlighting the importance of a comprehensive approach to smoking cessation.

Among the pharmacotherapies, nicotine replacement therapy (NRT), bupropion, and varenicline have shown efficacy, with varenicline being the newest option and receiving special attention for its clinical effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tobacco smoking cessation management: integrating varenicline in current practice. Galanti, LM.[2021]

In a study of over 1 million deliveries in Australia, varenicline exposure during pregnancy was associated with a lower risk of adverse perinatal events compared to unexposed women, suggesting it may be a safer option than previously thought.

Varenicline-exposed infants had lower rates of prematurity, being small for gestational age, and severe neonatal complications compared to those exposed to nicotine replacement therapy (NRT), challenging the current preference for NRT over varenicline in pregnant women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of smoking cessation pharmacotherapies during pregnancy is not associated with increased risk of adverse pregnancy outcomes: a population-based cohort study. Tran, DT., Preen, DB., Einarsdottir, K., et al.[2020]

A consensus among 37 international experts led to the development of decision rules for prescribing smoking cessation pharmacotherapy, emphasizing the importance of patient preferences and experiences alongside evidence-based practices.

The guidelines suggest specific combinations of therapies, such as using two forms of nicotine replacement therapy (NRT) or combining bupropion with NRT, particularly for patients with high dependence or those who have not succeeded with monotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An algorithm for tailoring pharmacotherapy for smoking cessation: results from a Delphi panel of international experts. Bader, P., McDonald, P., Selby, P.[2023]

Combination treatment with varenicline and nicotine replacement therapy (NRT) was found to be safe and well tolerated, with 39% of patients experiencing adverse events compared to 59% in the usual-care group.

There was no significant difference in smoking abstinence rates at 6 months between the combination therapy group (54%) and the usual-care group (59%), indicating that while the combination is safe, it may not provide a greater efficacy in smoking cessation compared to standard treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combination treatment with varenicline and nicotine replacement therapy. Ebbert, JO., Burke, MV., Hays, JT., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9293179/

Comparative clinical effectiveness and safety of tobacco ... Most tobacco cessation monotherapies and combination therapies are more effective than placebo at helping participants to achieve sustained abstinence.

2. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/2814489

Efficacy of Electronic Cigarettes vs Varenicline and ... Findings In this randomized clinical trial including 1068 smokers, ECs were as effective as varenicline and more effective than nicotine chewing ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0376871625003370

Efficacy and safety of varenicline for electronic cigarette ... Varenicline improved vaping cessation rates compared to placebo and was generally well tolerated, despite a higher incidence of nausea and vivid dreams.

4. frontiersin.org frontiersin.org/journals/public-health/articles/10.3389/fpubh.2024.1361186/full

a systemic review and network meta-analysis E-cigarettes and oronasal nicotine are more effective than no treatment in encouraging prevalent abstinence, but least likely to prompt dropout.

5. nejm.org nejm.org/doi/full/10.1056/NEJMoa2308815

Electronic Nicotine-Delivery Systems for Smoking Cessation The addition of e-cigarettes to standard smoking-cessation counseling resulted in greater abstinence from tobacco use among smokers than smoking ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38189560/

Electronic cigarettes for smoking cessation Authors' conclusions: There is high-certainty evidence that ECs with nicotine increase quit rates compared to NRT and moderate-certainty ...

7. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/2820176

Electronic Cigarettes vs Varenicline for Smoking Cessation ... This randomized clinical trial found that varenicline and nicotine-containing ECs were both effective in helping individuals in quitting smoking conventional ...

8. tobaccocontrol.bmj.com tobaccocontrol.bmj.com/content/early/2025/02/20/tc-2024-058798

Vaping cessation interventions: a systematic review and ... While long-term risks remain unclear, known dangers include nicotine addiction, E-cigarette or Vaping Use-Associated Lung Injury and potential ...