Tobacco Treatments for Smoking Cessation

(TEAL Trial)

Recruiting at 1 trial location

Overseen By Randi M. Williams, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Georgetown University

Disqualifiers: Prior lung cancer, hearing impairment, cognitive impairment, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 6 months

1188 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests different methods to help people quit smoking, focusing on those undergoing lung cancer screening. Participants will receive one of two treatments: a phone-based program with nicotine replacements or a standard quitline service (E-Referral to the Tobacco Quitline) that includes coaching and online resources. The primary goal is to determine how many participants can quit smoking for 3 to 6 months. The trial seeks individuals who have smoked recently (at least once in the past month) and qualify for a lung scan. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the treatments in this trial have undergone safety testing in people. The FDA has approved nicotine replacement therapy, a component of the phone-based tobacco treatment, to help people quit smoking, indicating its general safety. Previous studies have found that mobile and digital support for quitting smoking is well-tolerated by participants. These studies also found that text messages and chat-based support, combined with nicotine patches or gum, helped people quit smoking without major issues.

The e-referral to the Tobacco Quitline uses a standard method that includes coaching and nicotine replacement. The safety of this approach is well-documented, with widespread use of nicotine replacement therapy. Overall, these treatments aim to help people quit smoking safely and have been used successfully in other settings. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these smoking cessation treatments because they integrate innovative approaches to help people quit smoking more effectively. The phone-based tobacco treatment, combined with nicotine replacement and a stepped care intervention, offers a personalized approach that adapts to the individual's needs over time, potentially increasing success rates compared to traditional methods. Meanwhile, the e-referral to the Tobacco Quitline enhances accessibility by providing immediate support through standard coaching and resources, but with the added convenience of digital and text-based guidance. These methods aim to make quitting smoking more convenient and tailored, which may lead to higher rates of cessation success.

What evidence suggests that this trial's treatments could be effective for smoking cessation?

Research has shown that mobile phone programs can help people quit smoking. One study found that individuals who used these programs along with nicotine patches or gum were more successful at quitting after six months than those who only used nicotine patches or gum. In this trial, participants may receive a Phone-based Tobacco Treatment, Nicotine Replacement, and Stepped Care Intervention, which combines these elements. Another treatment arm involves an E-Referral to the Tobacco Quitline, which provides phone support services known as tobacco quitlines. These services become even more effective when combined with nicotine patches or gum. For those considering joining this trial, these treatments have shown promise in helping people quit smoking. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

The TEAL study is for current smokers aged 50-80 who have smoked more than a pack of cigarettes per year for over 20 years and are eligible for lung screening. Participants must speak English and be able to consent. Those with past lung cancer, hearing or cognitive impairments, or living with someone enrolled can't join.

Inclusion Criteria

Eligible for a screening or diagnostic scan

Currently smoking cigarettes (>1 in the past 30 days)

I am between 50-80 years old and have a smoking history of more than 20 pack-years.

Exclusion Criteria

Household member already enrolled

I have had lung cancer before.

I have hearing loss.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either the Quitline E-referral or MedStar Health System intervention, receiving phone-based counseling and nicotine replacement therapy

6 months

Regular phone-based sessions

Follow-up

Participants are monitored for smoking abstinence and engagement with the intervention

6 months

3-month and 6-month assessments

Economic Analysis

Conduct an economic analysis to evaluate costs and budget impact of the intervention

6 months

What Are the Treatments Tested in This Trial?

Interventions

• E-Referral to the Tobacco Quitline
• Phone-based Tobacco Treatment, Nicotine Replacement, and Stepped Care Intervention

Trial Overview This trial compares two smoking cessation methods: phone-based tobacco treatment combined with nicotine replacement and stepped care intervention versus an e-referral to the Tobacco Quitline. Success is measured by quitting smoking at 3 months (self-reported) and at 6 months (self-reported and confirmed).

How Is the Trial Designed?

Group I: MedStar Health System Experimental Treatment 1 Intervention

Phone-based Tobacco Treatment, Nicotine Replacement, and Stepped Care Intervention

Group II: E-Referral to the Tobacco Quitline Active Control 1 Intervention

Standard tobacco quitline protocol, including coaching, nicotine replacement, and web-, and text-based resources.

E-Referral to the Tobacco Quitline is already approved in United States for the following indications:

Approved in United States as E-Referral to Tobacco Quitline for:

• Smoking cessation

Who Is Running the Clinical Trial?

Georgetown University

Lead Sponsor

Trials

355

Recruited

142,000+

Published Research Related to This Trial

A pay-for-performance program significantly increased the rate of referrals to tobacco quitline services, with intervention clinics referring 11.4% of smokers compared to only 4.2% in usual care clinics, based on a study involving 49 clinics.

The program was particularly effective in clinics that had previously been less engaged in quality improvement, demonstrating that financial incentives can enhance clinician referral rates to evidence-based smoking cessation resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial of a pay-for-performance program targeting clinician referral to a state tobacco quitline. An, LC., Bluhm, JH., Foldes, SS., et al.[2022]

Systemic chemotherapy has been shown to improve symptoms and survival in advanced non-small cell lung cancer (NSCLC) patients, marking a shift from best supportive care to more aggressive treatment options.

Erlotinib is currently the only drug approved for third-line therapy in NSCLC, highlighting the need for further research to better define and optimize treatment strategies in this advanced stage of the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Third-line therapy for advanced non-small-cell lung cancer patients: a feasible therapeutic option? Galetta, D., Rossi, A., Colucci, G., et al.[2015]

The Internet-based smoking cessation intervention combined with a tele-health medication clinic had a greater reach and higher use of smoking cessation aids compared to traditional clinic-based care, involving 413 patients over a 12-month period.

Despite the increased reach, the quit rates at both 3 months (17% vs. 12%) and 12 months (13% vs. 16%) were not significantly different between the Internet intervention and the control group, indicating that more effective strategies are needed to improve smoking cessation outcomes in veterans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative Effectiveness of an Internet-Based Smoking Cessation Intervention Versus Clinic-Based Specialty Care for Veterans. Calhoun, PS., Datta, S., Olsen, M., et al.[2022]

The UC Quits project successfully implemented and maintained e-referrals to quitlines across five UC health systems, with an average of 3436 referrals annually over 5.5 years, demonstrating the feasibility of integrating this approach into clinical workflows.

E-referred patients had similar cessation outcomes to general quitline callers, with comparable rates of quitting attempts and success, indicating that e-referrals can effectively connect diverse patient populations to tobacco cessation resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation, Maintenance, and Outcomes of an Electronic Referral to a Tobacco Quitline Across Five Health Systems. Tong, EK., Zhu, SH., Anderson, CM., et al.[2023]

The study analyzed data from 92,220 patients with metastatic non-small cell lung cancer (NSCLC) and found that changes in Taiwan's National Health Insurance reimbursement policies significantly impacted the prescribing rates of targeted therapies gefitinib and erlotinib, with increases of 15.58% and 6.31% after policy changes.

The average time to prescription for these therapies decreased by up to 65.84% after insurance coverage was introduced, highlighting that removing reimbursement restrictions can greatly enhance both the accessibility and speed of treatment for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of removing reimbursement restrictions on targeted therapy accessibility for non-small cell lung cancer treatment in Taiwan: an interrupted time series study. Hsu, JC., Wei, CF., Yang, SC.[2020]

Combining epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) with cytotoxic chemotherapy has shown a high disease control rate and improved progression-free survival in patients with EGFR-mutated non-small-cell lung cancer (NSCLC).

Further randomized phase III studies are needed to confirm the survival benefits of this combination therapy, while other promising strategies, such as combining EGFR-TKIs with bevacizumab and immune checkpoint inhibitors, are being explored for future lung cancer treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is epidermal growth factor receptor tyrosine kinase inhibitor in combination with cytotoxic chemotherapy a better treatment option for patients with EGFR-mutated non-small-cell lung cancer? Takahashi, K., Saito, H.[2020]

In a retrospective review of 35 patients with recurrent metastatic non-small-cell lung cancer (NSCLC), second-line treatment with erlotinib showed the highest mean time to progression (TTP) of 9.2 months and a 40% overall response rate, indicating its efficacy after first-line platinum-based chemotherapy.

The study suggests that second-line erlotinib is well-tolerated and does not negatively impact the effectiveness of subsequent third-line chemotherapy, making it a valuable option for patients who have progressed after initial treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retrospective practice review of treatment of metastatic non-small-cell lung cancer with second-line erlotinib. Melosky, B., Agulnik, J., Assi, H.[2021]

The Ask-Advise-Connect (AAC) approach significantly increased the enrollment of smokers in treatment programs, with 7.8% of identified smokers enrolling compared to only 0.6% in the traditional Ask-Advise-Refer (AAR) method, representing a 13-fold increase.

This study involved 10 family practice clinics in Houston, Texas, and assessed smoking status for over 42,000 patients, demonstrating that proactive outreach by quitlines can effectively link smokers to cessation resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ask-Advise-Connect: a new approach to smoking treatment delivery in health care settings. Vidrine, JI., Shete, S., Cao, Y., et al.[2022]

Combination nicotine replacement therapy (NRT) for 6 weeks significantly increased the 6-month point-prevalence abstinence rate to 51.6%, compared to 38.4% for 2 weeks of nicotine patch alone, indicating that longer and combined therapies are more effective in helping people quit smoking.

The study suggests that offering combination NRT for either 2 or 6 weeks can improve quit rates by 10% to 13% over standard nicotine patch therapy, potentially leading to an additional 50,000 successful quitters annually among U.S. quitline callers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing tobacco quitline effectiveness: identifying a superior pharmacotherapy adjuvant. Smith, SS., Keller, PA., Kobinsky, KH., et al.[2023]

Several new second-line treatment options for non-small-cell lung cancer (NSCLC) have been approved, including anti-EGFR agents like afatinib, anti-angiogenics like nintedanib and ramucirumab, and immunotherapies such as nivolumab, pembrolizumab, and atezolizumab.

When considering second-line therapies, the focus should be on improving survival while also managing side effects and maintaining the quality of life for patients, as different treatments have varying toxicity profiles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety of second-line treatment options for non-small cell lung cancer. Rossi, A., Maione, P., Santabarbara, G., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6485940/

Mobile phone‐based interventions for smoking cessation - PMC Authors' conclusions. The current evidence supports a beneficial impact of mobile phone‐based smoking cessation interventions on six‐month cessation outcomes.

2. mhealth.jmir.org mhealth.jmir.org/2022/11/e41658

Outcomes of a Comprehensive Mobile Smoking Cessation ... This study aimed to compare engagement, retention, attitudes toward quitting smoking, smoking behavior, and participant feedback between Pivot and QuitGuide.

3. nejm.org nejm.org/doi/full/10.1056/NEJMp2500683

The Contribution of Digital Treatment to Efforts to Reduce ... We define digital tobacco-cessation interventions as treatments delivered by means of digital media, without direct human involvement. A key ...

4. tobaccoinduceddiseases.org tobaccoinduceddiseases.org/Effect-of-mobile-interventions-with-nicotine-replacement-ntherapy-sampling-on-long,160168,0,2.html

Effect of mobile interventions with nicotine replacement ... A recent RCT in unmotivated smokers showed that mobile intervention plus NRT-S led to higher abstinence at 6 months than NRT-S alone. Our pilot ...

5. withpower.com withpower.com/trial/tobacco-treatments-for-smoking-cessation-dbb60

Tobacco Treatments for Smoking Cessation (TEAL Trial) Research shows that tobacco quitlines, which provide phone-based support, are effective in helping people quit smoking. Enhancements like nicotine replacement ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9732762/

Outcomes of a Comprehensive Mobile Smoking Cessation ... This study aimed to compare engagement, retention, attitudes toward quitting smoking, smoking behavior, and participant feedback between Pivot and QuitGuide.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03740490

Smartphone Based Smoking Cessation Intervention Smartphone-based smoking cessation apps could offer easily accessible, highly tailored, and intensive interventions at a fraction of the cost of traditional ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6571033/

Proactive text messaging (GetReady2Quit) and nicotine ... Text messages that deliver tobacco cessation support increases abstinence among smokers interested in quitting in community- or school-based settings.

9. tobaccoinduceddiseases.org tobaccoinduceddiseases.org/Mobile-chat-based-support-plus-nicotine-replacement-therapy-nsampling-to-promote,133373,0,2.html

Mobile chat-based support plus nicotine replacement ... Mobile chat-based support plus NRT-S was feasible and showed preliminary evidence of increased quitting, smoking reduction, quit attempts, and NRT-S use.