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

144 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to develop and evaluate an evidence-based intervention to assist adolescents and young adults with current vaping to quit vaping and smoking.

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 data supports the idea that Tobacco Use Treatment for Smoking Cessation is an effective treatment?

The available research shows that Tobacco Use Treatments like nicotine replacement therapy (NRT), bupropion, and varenicline are effective in helping people quit smoking. Varenicline has been found to be the most effective, with a higher success rate compared to NRT and bupropion. For example, one study found that varenicline had an effectiveness rate of 3.09 times better than a placebo, while bupropion was 1.94 times better, and NRT was 1.77 times better. This means that varenicline is more likely to help people stop smoking compared to the other treatments. Additionally, varenicline has shown better results than the nicotine patch in some studies. Overall, these treatments are effective, but varenicline seems to be the most successful option for quitting smoking. ^{1 2 3 4 5}

What data supports the effectiveness of the drugs used in the Tobacco Use Treatment for Smoking Cessation trial?

Research shows that nicotine replacement therapy (NRT), bupropion, and varenicline are effective in helping people quit smoking, with varenicline being the most effective among them. These drugs have been shown to help people stop smoking for at least 6 months, and they are often used together with behavioral support to improve success rates. ^{1 2 3 4 5}

What safety data exists for smoking cessation treatments?

Safety data for smoking cessation treatments such as nicotine replacement therapy (NRT), bupropion, and varenicline indicate that these are generally effective and have been studied for serious adverse events. Studies show no increased risk of adverse pregnancy outcomes with these treatments during pregnancy. The EAGLES trial assessed neuropsychiatric safety in individuals with psychiatric disorders. However, there is limited data on the safety of combining varenicline with NRT. A systematic review compared the safety of these pharmacotherapies and electronic cigarettes. ^{1 6 7 8 9}

Is the Tobacco Use Treatment for Smoking Cessation safe for humans?

Nicotine replacement therapy (NRT), bupropion, and varenicline are generally considered safe for helping people quit smoking, even in those with psychiatric disorders. They have been studied for safety in various conditions, including pregnancy, without showing increased risks of serious adverse events. ^{1 6 7 8 9}

Is the E-cigarette & Tobacco Use Treatment a promising treatment for quitting smoking?

Yes, the E-cigarette & Tobacco Use Treatment, which includes drugs like Nicotine Replacement Therapy (NRT), Varenicline, and Bupropion, is promising for quitting smoking. These drugs have been shown to help people stop smoking, especially when combined with support and guidance. ^{2 3 10 11 12}

How is the E-cigarette & Tobacco Use Treatment Intervention different from other smoking cessation treatments?

This treatment is unique because it combines multiple pharmacotherapies like nicotine replacement therapy (NRT), varenicline, and bupropion, along with e-cigarettes, to help people quit smoking. This multi-faceted approach may offer more flexibility and potentially higher success rates compared to using a single method. ^{2 3 10 11 12}

Research Team

Abbey Masonbrink, MD

Principal Investigator

Children's Hospital Los Angeles

Eligibility Criteria

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 either younger than 14 or older than 21.

I am not comfortable with English.

I am too sick to take part in this study.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Pharmacological treatments for smoking cessation. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Pharmacotherapy for tobacco cessation: nicotine agonists, antagonists, and partial agonists. [2021]

3. England pubmed.ncbi.nlm.nih.gov

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

4. United States pubmed.ncbi.nlm.nih.gov

Comparative Effectiveness of Smoking Cessation Medications: A National Prospective Cohort From Taiwan. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Varenicline versus transdermal nicotine patch for smoking cessation: results from a randomised open-label trial. [2022]

6. England 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. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Combination treatment with varenicline and nicotine replacement therapy. [2022]

8. United States 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. [2020]

9. England 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. [2022]

10. New Zealand pubmed.ncbi.nlm.nih.gov

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

11. England 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. [2021]

12. England pubmed.ncbi.nlm.nih.gov

Comparison of the effectiveness of varenicline and combination nicotine replacement therapy for smoking cessation in clinical practice. [2021]