Personalized Tobacco Treatment for Smoking Cessation

Recruiting at 1 trial location

Overseen By Alex Ramsey, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Must not be taking: Smoking cessation medications

Disqualifiers: Cardiac problems, Pregnancy, others

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

Compensation: Varies

Number of Visits: 1

850 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to help people quit smoking by tailoring treatment to their unique health profile, including clinical data and genetics. It compares this personalized treatment, known as Precision Treatment, to the usual care provided for quitting smoking in primary care clinics. The trial aims to determine if this personalized method helps more people successfully quit smoking and adhere to their treatment plan. Participants should be current smokers willing to use medication like nicotine patches or lozenges to aid in quitting. As an unphased trial, this study offers participants a unique opportunity to contribute to innovative research that could transform smoking cessation strategies.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot be actively using smoking cessation medications or have received a prescription for them in the past 30 days.

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

Research shows that personalized treatments to help people quit smoking might be safe. Studies have found that tailoring treatments to individual needs, such as genetics and biological markers, can enhance the effectiveness of quitting smoking. So far, no clear evidence of major safety issues has emerged with this approach.

Common medications for quitting smoking, like varenicline and bupropion, have proven effective and safe for people with heart disease. This suggests that personalized treatments using similar methods could also be well-tolerated.

It's important to note that this trial does not primarily focus on safety. This might indicate that earlier research hasn't revealed significant safety concerns. If specific worries arise, discussing them with the trial team might help. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PrecisionTx treatment for smoking cessation because it offers a personalized approach, unlike the standard guideline-based options such as nicotine replacement therapy or prescribed medications like varenicline. PrecisionTx tailors tobacco treatment recommendations specifically for each patient, potentially increasing the effectiveness of quitting smoking. This personalized strategy, combined with behavioral support, aims to address individual needs more accurately, making it a promising new direction in helping people quit smoking.

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

Research has shown that personalized treatments for quitting smoking can outperform standard methods. In this trial, participants will join different treatment arms to evaluate these approaches. The PrecisionTx arm includes digital and interactive programs tailored to each individual, which studies have found to be more successful in helping people quit smoking over time. For instance, one study found that personalized methods increased quit rates from 12% to 17.2%. Another study showed that structured, personalized plans were much more effective than unstructured attempts, which succeeded only 3%-5% of the time. This suggests that customizing treatment to fit each person's unique needs can facilitate smoking cessation. Meanwhile, the Usual Care arm will represent standard methods, providing guideline-based tobacco treatment advice. ^{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?

The MOTIVATE trial is for adult smokers who currently smoke at least 5 cigarettes per day and have used or been prescribed smoking cessation medication in the last month. It's also for clinicians from participating clinics who are adults and speak English.

Inclusion Criteria

Clinician from participating clinic

Patient at participating clinic

Current smoking (cigarettes per day >=5)

Exclusion Criteria

I cannot use certain stop-smoking aids due to allergies, heart issues, or pregnancy.

I have used smoking cessation medication in the last 30 days.

I have recently started or been prescribed medication to quit smoking.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive either usual care or precision treatment intervention for smoking cessation

6 months

Regular visits as per intervention protocol

Follow-up

Participants are monitored for smoking cessation success and other outcomes

12 months

Assessments at 1, 3, 6, and 12 months post-intervention

What Are the Treatments Tested in This Trial?

Interventions

• Precision Treatment
• Usual Care

Trial Overview This study tests a personalized tobacco treatment against usual care in primary care settings. The new approach uses clinical, genetic, and biomarker data to tailor recommendations, aiming to improve patient adherence and clinician prescribing practices.

How Is the Trial Designed?

Group I: PrecisionTx Experimental Treatment 1 Intervention

Physicians will receive PrecisionTx, an intervention designed to recommend precision tobacco treatment. Patients will receive PrecisionTx, an intervention designed to recommend precision tobacco treatment, and a brief discussion with a behavior interventionist.

Group II: Usual Care Active Control 1 Intervention

The arm will represent usual care in the primary care clinics. Physicians will receive a report designed to recommend guideline-based tobacco treatment. Patients will receive a report on guideline-based advice about smoking cessation and a brief discussion with a behavior interventionist.

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

Over 70% of smokers surveyed in a study of low-income, predominantly African-American adults expressed favorable attitudes toward precision smoking treatment, indicating a strong interest in personalized approaches to quitting smoking.

Smokers with higher motivation and confidence to quit were more likely to have positive attitudes toward precision treatment, suggesting that targeted interventions could help engage those with lower motivation and confidence in smoking cessation efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Attitudes toward Precision Treatment of Smoking in the Southern Community Cohort Study. Senft, N., Sanderson, M., Selove, R., et al.[2021]

The study involves 392 African American smokers who are being compared in two groups: one receiving optimized pharmacotherapy (OPT) with adaptations based on smoking status, and the other receiving enhanced usual care (UC) with standard nicotine patches.

The hypothesis is that the OPT approach, which includes personalized medication adjustments, will lead to higher rates of biochemically verified smoking abstinence at Week 12 compared to the UC group, potentially improving treatment outcomes for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocol from a randomized clinical trial of multiple pharmacotherapy adaptations based on treatment response in African Americans who smoke. Nollen, NL., Cox, LS., Mayo, MS., et al.[2022]

In a study analyzing 33,077 participants in a smoking cessation program, the effectiveness of various types and doses of nicotine replacement therapy (NRT) did not significantly vary based on individual characteristics, suggesting a uniformity in treatment outcomes.

Both the main effects model and the model including interactions showed similar predictive accuracy for quit success, indicating that personalizing smoking cessation treatments based on participant demographics may not enhance effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can nicotine replacement therapy be personalized? A statistical learning analysis. Veldhuizen, S., Zawertailo, L., Hussain, S., et al.[2022]

The article proposes a framework to systematically include biological data and samples in smoking cessation trials, supporting the goals of the Precision Medicine Initiative.

By encouraging researchers to collect biosamples and perform genetic analyses, the framework aims to enhance the effectiveness of pharmacotherapy for nicotine dependence through personalized treatment approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Leveraging Genomic Data in Smoking Cessation Trials in the Era of Precision Medicine: Why and How. Chen, LS., Zawertailo, L., Piasecki, TM., et al.[2023]

Smoking cessation is crucial for disease prevention, with 70% of smokers wanting to quit, but only 3-5% succeed without intervention, highlighting the need for effective support.

Recent advancements in pharmacotherapies, including nicotine replacement therapy, bupropion, and varenicline, provide clinicians with options to personalize treatment, potentially increasing the success rate of quitting smoking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smoking cessation through the utilization of pharmacotherapy. Harrington, KF., Bailey, WC.[2010]

In a study involving 54 American Indian adults who smoke, a significant correlation was found between the nicotine metabolite ratio (NMR) and measures of cigarette dependence, indicating that NMR could be a useful biomarker for tailoring smoking cessation treatments.

While 54% of participants' preferences for pharmacotherapy aligned with NMR-informed recommendations, the overall acceptability of this approach was lower in this group compared to other populations, suggesting the need for community-specific strategies to improve the effectiveness of precision medicine in smoking cessation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring Potential for a Personalized Medicine Approach to Smoking Cessation With an American Indian Tribe. Carroll, DM., Murphy, S., Meier, E., et al.[2023]

Research has identified specific genetic variants, such as those in the CHRNA5 gene and the CYP2A6 gene, that are associated with nicotine dependence and may predict success in smoking cessation treatments.

Emerging evidence suggests that biomarkers, including the nicotine metabolite ratio, can help personalize smoking cessation strategies, enhancing the effectiveness of treatments based on an individual's genetic profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Value of Biosamples in Smoking Cessation Trials: A Review of Genetic, Metabolomic, and Epigenetic Findings. Saccone, NL., Baurley, JW., Bergen, AW., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07166120

Precision Treatment to Promote Smoking Cessation and ... This study evaluates the feasibility and preliminary effects of precision tobacco treatment, compared to usual care, on promoting tobacco ...

2. nature.com nature.com/articles/s41562-025-02295-2

Efficacy of digital interventions for smoking cessation by ... Personalized and interactive digital interventions also showed high quit success rates in promoting prolonged abstinence, with SMS, telephone ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10858725/

A Review of Smoking Cessation Interventions - PubMed Central Moreover, attempting to quit smoking without any structured approach yielded a mere 3%-5% success rate within the same timeframe [7]. This study ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2589004224023150

Personalized and adaptive interventions for smoking ... In the US, an analysis of the PATH study dataset showed a 10% twelve-month smoking quit rate for people who used pharmacotherapy (including NRTs) ...

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

Increased Reach and Effectiveness with a Low-Burden ... Effectiveness: The proportion of tobacco smokers who subsequently achieved cessation increased significantly from pre-ELEVATE to post-ELEVATE (12.0% vs. 17.2%, ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04897607

Precision Pharmacotherapy Smoking Cessation Program Preliminary data suggest that personalized treatment recommendations may increase smoking cessation medication uptake and effectiveness. Thus, the ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2772392523000160

The use of biomarkers to guide precision treatment for ... This review summarizes the evidence to date on the development of biomarkers for personalizing the pharmacological treatment of combustible tobacco use.

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

Public Health Impact of FDA's Request for Additional Safety ... Public Health Impact of FDA's Request for Additional Safety Data on Cytisine for Tobacco Cessation · Medical Practice Evaluation Center, Mongan ...

9. reporter.nih.gov reporter.nih.gov/search/4Yj5Ce3DiU2-0GnItU5Q_g/project-details/10874467

Project Details - NIH RePORTER This study will test the impact of a multilevel precision treatment intervention on improving tobacco treatment and health outcomes in primary care. ... Safety ...

10. ahajournals.org ahajournals.org/doi/10.1161/CIRCOUTCOMES.115.002458

Efficacy and Safety of Smoking Cessation Interventions in ... Our meta-analysis suggests varenicline and bupropion, as well as individual and telephone counseling, are efficacious for smoking cessation in CVD patients.