Metabolism Informed Smoking Treatment in Medicaid and Medicare Patients: The MIST RCT

医疗补助和医疗保险患者的代谢知情吸烟治疗：MIST 随机对照试验

• 批准号: 10377378
• 负责人: Hilary A. Tindle
• 金额: $ 84.28万
• 依托单位: VANDERBILT UNIVERSITY MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-04-08 至 2024-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10377378
• 关键词: Abstinence; Academic Medical Centers; Adult; Aftercare; American; Biochemical; Biological Markers; Cessation of life; Clinical Treatment; Clinical Trials; Confidence Intervals; Consult; Cotinine; Counseling; Cytochrome P450; Data; Databases; Disease; Drug Prescriptions; Enrollment; Enzymes; FDA approved; Health system; Healthcare; Hospitalization; Hospitals; Information Systems; Infrastructure; Inpatients; Liver; Malignant Neoplasms; Medicaid; Medical; Medicare; Metabolism; Nicotine; Nicotine Dependence; Odds Ratio; Outcome; Outcome Study; Participant; Patient Self-Report; Patients; Persons; Pharmaceutical Preparations; Pharmacogenomics; Pharmacotherapy; Pharmacy facility; Positioning Attribute; Prevalence; Provider; Publishing; Randomized; Records; Research; Research Personnel; Risk; Salivary; Smoke; Smoker; Smoking; Smoking Status; South American; Speed; Surveys; Telephone; Tennessee; Testing; Time; Tobacco; Tobacco use; Validation; Visit; Work; adherence rate; arm; base; beneficiary; cigarette smoking; clinical care; clinical implementation; clinical practice; design; health care service utilization; high risk; hydroxycotinine; improved; medication compliance; member; mortality; nicotine patch; personalized approach; pharmacy benefit; precision medicine; side effect; smoking abstinence; smoking cessation; smoking-related disease; success; treatment as usual; treatment response; treatment services; varenicline

Project Summary The American Southeast has some of the highest rates of cigarette smoking and smoking-attributable cancer mortality in the nation. Medicaid and Medicare (CMS) beneficiaries who smoke are at high risk of smoking- related disease, yet each year fewer than one in five CMS-enrolled smokers (and fewer than one in ten Tennessee Medicaid smokers) with pharmacy benefits receive smoking cessation medication. Furthermore, when smoking cessation medication is provided, it is not biologically tailored for maximum efficacy. The ratio of 3-hydroxycotinine to cotinine, known as the nicotine metabolite ratio (NMR), reflects CYP2A6 activity and the rate of nicotine metabolism. Among “normal” metabolizers as assessed by NMR, varenicline produces quit rates roughly double those of nicotine patch at 6 months (23% vs. 13%, p<0.05), while among “slow” metabolizers, quit rates do not differ by drug. The number needed to treat to help one normal metabolizer quit smoking is only 4.9 for varenicline vs. 26 for nicotine patch, establishing the scientific premise to pair normal metabolizers with varenicline and slow metabolizers with nicotine. We propose to test Metabolism-Informed Smoking Treatment (MIST), a precision approach that biologically tailors medication to nicotine metabolism, for CMS beneficiaries in the Mid-South who smoke. We hypothesize that MIST will be superior to usual care (UC), i.e., selection of medication uninformed by NMR, for smoking cessation. We randomized 81 adult daily smokers at Vanderbilt University Medical Center (VUMC) to MIST vs control. MIST increased NMR-medication match rates more than 3-fold: unadjusted odds ratio 3.67 (95% confidence interval 1.33-11.00; p-value=0.02), and was highly acceptable to patients. To assess the efficacy of MIST relative to UC for abstinence and its use by patients and providers in clinical practice, the MIST RCT will enroll 1,000 CMS-enrolled adult daily smokers who are hospitalized and counseled by the inpatient VUMC Tobacco Treatment Service. Specific AIMS are to compare the effects of MIST vs. UC on: (1) Abstinence at 6 months (1a, 1° study outcome), defined by biochemically-verified 7-day point prevalence abstinence, and 12 months (1b, 2° outcome); (2) Clinical implementation, defined by patient self-reported medication adherence (2a, 2° outcome), PCP prescription of medication for patients smoking after hospital discharge (2b, 2° outcome), and whether the prescription is NMR-matched (2c, 2° outcome); and (3) Health care utilization and mortality (exploratory) as tracked by existing databases including the statewide Tennessee Hospital Discharge Data System and CMS data. All participants will receive counseling and medication for tobacco use. Investigators have broad, complementary expertise in smoking cessation clinical trials, precision medicine, smoking pharmacogenomics, and use of large databases, and leverage extensive health system infrastructure. IMPACT: This is the first large RCT to incorporate nicotine metabolism into clinical care, and could fundamentally shift smoking treatment away from a generic approach and into the era of precision medicine.

项目总结