Technology-Assisted Interventions for Smoking Cessation

Overseen By Li-Shiun Chen, M.D., MPH, ScD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Washington University School of Medicine

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

2400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two methods to help people quit smoking, particularly those receiving medical care for cancer prevention. One method uses a standard approach, while the other adds extra support with nudges to encourage quitting. The methods being tested are called ELEVATE and ELEVATE-S. Adults who use tobacco and receive care at a participating clinic might be suitable candidates. The goal is to determine which method more effectively helps people quit smoking. As an unphased trial, this study provides a unique opportunity to contribute to research that could improve smoking cessation strategies for many.

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. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these technology-assisted interventions are safe for smoking cessation?

Research has shown that the medications used in the ELEVATE program to help people quit smoking do not increase the risk of serious heart problems. These treatments have undergone studies for heart safety and are generally well-tolerated.

For ELEVATE-S, which may use electronic methods to aid smoking cessation, electronic cigarettes and similar devices have been researched. Some studies suggest they can help people stop smoking, but known risks exist, especially for young people and adults.

Overall, both methods aim to help people quit smoking, and past research suggests they are safe for humans, with some manageable side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ELEVATE and ELEVATE-S interventions for smoking cessation because they harness the power of electronic health records to deliver personalized, evidence-based tobacco treatments. Unlike traditional methods like nicotine replacement therapy or counseling, these interventions integrate seamlessly into healthcare systems, allowing for customized support and tracking of patient progress in real-time. This innovative approach could improve accessibility and effectiveness, making it easier for individuals to quit smoking with tailored support.

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

Studies have shown that ELEVATE, one of the treatments in this trial, significantly increases the number of smokers who receive help to quit. Before ELEVATE, only 1.6% of smokers received treatment to stop smoking, but this rose to 27.9% after the program began. The success rate for quitting smoking also improved from 12.0% to 17.2%. Quitting smoking, especially after a cancer diagnosis, can greatly improve survival chances. ELEVATE-S, another treatment option in this trial, builds on these methods by offering extra support, which could further enhance the chances of quitting successfully. ^{6 7 8 9 10}

Who Is on the Research Team?

Li-Shiun Chen, M.D., MPH, ScD

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

This trial is for adults over 18 who currently use tobacco and are receiving care at a participating clinic. They must have completed an appointment with the clinic to qualify. The study aims to help them quit smoking by comparing two strategies.

Inclusion Criteria

I am at least 18 years old.

I am being treated at a clinic that is part of the clinical trial.

I currently use tobacco.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive tobacco use treatment through either ELEVATE or ELEVATE-S strategies

12 months

Follow-up

Participants are monitored for smoking cessation and treatment effectiveness

12 months

What Are the Treatments Tested in This Trial?

Interventions

• ELEVATE
• ELEVATE-S

Trial Overview The CONNECT trial is testing two different methods to help cancer survivors stop smoking: ELEVATE, which is usual care focused on quitting, and ELEVATE-S, which includes additional 'nudges' or prompts designed to increase tobacco treatment uptake.

How Is the Trial Designed?

Group I: Electronic health record-enabled evidence-based tobacco treatment-Support (ELEVATE-S) Experimental Treatment 1 Intervention

Group II: Electronic health record-enabled evidence-based tobacco treatment (ELEVATE) Active Control 1 Intervention

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9173433/

Increased Reach and Effectiveness with a Low-Burden ... ELEVATE, a low-burden point-of-care intervention, was associated with increased reach and effectiveness of smoking cessation treatment.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35545172/

Increased Reach and Effectiveness With a Low-Burden Point ... Results: The proportion of current tobacco smokers receiving cessation treatment increased from pre-ELEVATE to post-ELEVATE (1.6%-27.9%; difference, 26.3%; ...

3. translationalsciencebenefits.wustl.edu translationalsciencebenefits.wustl.edu/case-study/advancing-equitable-treatment-for-smoking-cessation-in-cancer-patients/

Advancing Equitable Treatment for Smoking Cessation in ... Additionally, ELEVATE increased the effectiveness of patient smoking cessation from 12.0% to 17.2%. ELEVATE addresses equity in many ways.

4. renalandurologynews.com renalandurologynews.com/news/quitting-smoking-following-cancer-diagnosis-improves-survival-study-suggests/

Quitting Smoking Following Cancer Diagnosis Improves ... Smoking cessation after cancer diagnosis is linked to improved overall survival even for advanced cancers, according to a recent study.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0306460321001052

Contingency management for smoking cessation among ... This study aims to examine the effect of CM on smoking outcomes and in-treatment behaviors (i.e., retention, session attendance and adherence to nicotine use ...

6. evotec.com evotec.com/news/evotec-reports-phase-i-safety-data-from-tyramine-interaction-study-with-evt-302

Evotec Reports Phase I Safety Data from Tyramine Interaction ... At the highest EVT 302 dose tested (>5 fold the expected therapeutic dose), a small increase in tyramine sensitivity was produced, which was within the range of ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/29630702/

Cardiovascular Safety of Varenicline, Bupropion, and ... The findings of EAGLES and its extension trial provide further evidence that smoking cessation medications do not increase the risk of serious ...

8. jamanetwork.com jamanetwork.com/journals/jama-health-forum/fullarticle/2822687

Public Health Impact of FDA's Request for Additional Safety ... We applied a 10% probability of smoking relapse after 1 year of abstinence. For life expectancy gains from smoking cessation at different ages ( ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S0273230017303975

Evaluation of the safety profile of an electronic vapour ... The most frequently reported AEs were headache, nasopharyngitis, sore throat and cough, reported by 28.7%, 28.7%, 19.6% and 16.7% of subjects, respectively, ...

10. hhs.gov hhs.gov/sites/default/files/hhs-framework-support-accelerate-smoking-cessation-2024.pdf

HHS Framework to Support and Accelerate Smoking ... This longitudinal cohort study, launched in 2011 and ongoing, provides data on tobacco use behaviors, attitudes and beliefs, and tobacco-related outcomes. • NIH ...