Personalized Tobacco Treatment for Smoking Cessation

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

Trial Summary

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.

What data supports the effectiveness of the Personalized Tobacco Treatment for smoking cessation?

Research suggests that using biological data to tailor smoking treatments, like nicotine replacement therapy, can improve outcomes by matching the right type and dose to individual needs. This personalized approach may enhance the effectiveness of smoking cessation efforts. ^{1 2 3 4 5}

Is Personalized Tobacco Treatment safe for humans?

The research articles do not provide specific safety data for Personalized Tobacco Treatment, but they discuss the potential of using genetic and biological data to tailor smoking cessation treatments. This approach is part of precision medicine, which aims to improve treatment effectiveness by considering individual differences. ^{1 2 3 4 6}

What makes the Precision Treatment for smoking cessation unique?

Precision Treatment for smoking cessation is unique because it uses biological data, like genetic information or biomarkers (biological indicators), to tailor the treatment to each individual, potentially making it more effective than standard care. This personalized approach aims to address the specific needs of different groups, such as racial/ethnic minorities, who may have less success with conventional treatments. ^{1 2 3 4 7}

What is the purpose of this trial?

This study examines the application of precision treatment intervention for smoking cessation from both the clinician perspective and patient perspective, and compares it to usual care on tobacco treatment in the primary care setting. The precision treatment intervention includes personalized tobacco treatment recommendations using the patient's clinical, genetic, and biomarker information. This approach may increase effectiveness and adherence for the patient, and increase the clinician's likelihood of prescribing.

Research Team

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

Principal Investigator

Washington University School of Medicine

Eligibility Criteria

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

Patient at participating clinic

Clinician from participating clinic

Can speak and understand English

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

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

Attitudes toward Precision Treatment of Smoking in the Southern Community Cohort Study. [2021]

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

Can nicotine replacement therapy be personalized? A statistical learning analysis. [2022]

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

Exploring Potential for a Personalized Medicine Approach to Smoking Cessation With an American Indian Tribe. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Leveraging Genomic Data in Smoking Cessation Trials in the Era of Precision Medicine: Why and How. [2023]

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

Smoking cessation through the utilization of pharmacotherapy. [2010]

6. England pubmed.ncbi.nlm.nih.gov

The Value of Biosamples in Smoking Cessation Trials: A Review of Genetic, Metabolomic, and Epigenetic Findings. [2023]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Protocol from a randomized clinical trial of multiple pharmacotherapy adaptations based on treatment response in African Americans who smoke. [2022]