Personalized Tobacco Treatment for Smoking Cessation
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Washington University School of Medicine
Must not be taking: Smoking cessation medications
Disqualifiers: Cardiac problems, Pregnancy, others
No Placebo Group
Trial Summary
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.
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.
12345Is 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.
12346What 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.
12347Eligibility 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
I am 18 years old or older.
Patient at participating clinic
Clinician from participating clinic
+4 more
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.
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: PrecisionTxExperimental Treatment1 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 CareActive Control1 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Washington University School of MedicineSaint Louis, MO
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Who Is Running the Clinical Trial?
Washington University School of MedicineLead Sponsor
National Cancer Institute (NCI)Collaborator
National Institute on Drug Abuse (NIDA)Collaborator
References
Attitudes toward Precision Treatment of Smoking in the Southern Community Cohort Study. [2021]Precision interventions using biological data may enhance smoking treatment, yet are understudied among smokers who are disproportionately burdened by smoking-related disease.
Can nicotine replacement therapy be personalized? A statistical learning analysis. [2022]Technology has made automated care personalization practical, but useful personalization requires information about systematic differences between individuals in the effectiveness of different interventions. Here, we used observational data to search for differences in smoking cessation treatment outcomes associated with interactions between participant characteristics and different types and doses of nicotine replacement therapy (NRT).
Exploring Potential for a Personalized Medicine Approach to Smoking Cessation With an American Indian Tribe. [2023]A potential precision medicine approach to smoking cessation is tailoring pharmacotherapy to a biomarker known as the nicotine metabolite ratio (NMR). Little is known about the potential impact and acceptability of this approach for American Indian (AI) persons.
Leveraging Genomic Data in Smoking Cessation Trials in the Era of Precision Medicine: Why and How. [2023]This article outlines a framework for the consistent integration of biological data/samples into smoking cessation pharmacotherapy trials, aligned with the objectives of the recently unveiled Precision Medicine Initiative. Our goal is to encourage and provide support for treatment researchers to consider biosample collection and genotyping their existing samples as well as integrating genetic analyses into their study design in order to realize precision medicine in treatment of nicotine dependence.
Smoking cessation through the utilization of pharmacotherapy. [2010]Smoking cessation is the single most effective behavioral change for disease prevention. While almost 20% of the US population smokes, 70% of these smokers indicate they would like to quit. However, only approximately 3-5% of smokers quit without the aid of some intervention. Best practice suggests that every patient who smokes is offered brief behavioral counseling with pharmacotherapy support for smoking cessation. The past decade has presented new pharmacotherapies for tobacco cessation that allow the clinician more options for individualizing therapy to maximize each patient's chance for tobacco abstinence. Nicotine replacement therapy, bupropion sustained release and varenicline are discussed as monotherapies and in combination. As the understanding of neuropharmacology increases and new pharmacotherapies are developed, there will be the possibility of tailoring therapies for individual patients based on genetic predispositions and other individual characteristics.
The Value of Biosamples in Smoking Cessation Trials: A Review of Genetic, Metabolomic, and Epigenetic Findings. [2023]Human genetic research has succeeded in definitively identifying multiple genetic variants associated with risk for nicotine dependence and heavy smoking. To build on these advances, and to aid in reducing the prevalence of smoking and its consequent health harms, the next frontier is to identify genetic predictors of successful smoking cessation and also of the efficacy of smoking cessation treatments ("pharmacogenomics"). More broadly, additional biomarkers that can be quantified from biosamples also promise to aid "Precision Medicine" and the personalization of treatment, both pharmacological and behavioral.
Protocol from a randomized clinical trial of multiple pharmacotherapy adaptations based on treatment response in African Americans who smoke. [2022]The standard of care in tobacco treatment is to continue individuals who smoke on the same cessation medication, even when they do not stop smoking. An alternative strategy is to adapt pharmacotherapy based on non-response. A handful of studies have examined this approach, but they have adapted pharmacotherapy only once and/or focused on adaptation distal rather than proximal to a failed quit attempt. Few studies have included racial/ethnic minorities who have less success in quitting and bear a disproportionate share of tobacco-related morbidity and mortality.