Metabolism-informed Care for Smoking Cessation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 82
- 主要终点
- Theoretical Endorsement of MIC as assessed by level of agreement to a set of seven 5-point Likert Scale questions
研究概览
简要总结
Nicotine mediates smoking's addictive effects in the brain. The ratio of 3-hydroxycotinine to cotinine, known as the nicotine metabolite ratio, or NMR, is a genetically- informed biomarker reflecting hepatic CYP2A6 activity and the rate of nicotine metabolism. In light of a recent randomized controlled trial (RCT) in humans in Lancet Respiratory Medicine, which found that the NMR can be used to individualize treatment for smokers, our pilot study aims to determine the feasibility of using NMR to guide selection of pharmacotherapy in clinical populations of daily smokers.
详细描述
Consenting participants will be assigned to guideline-based care (GBC: incorporating national guidelines and more recent evidence from clinical trials of pharmacotherapy for smoking cessation) or metabolism-informed care (MIC: identical to GBC but selection of medication based on NMR result). All participants received counseling from a nurse level certified tobacco counseling. After consent, participants undergo a blood draw for NMR, complete a baseline questionnaire, and are randomized to GBC or MIC. At approximately 1, 3, and 6 months post-consent, participants will provide follow up information via telephone questionnaire regarding symptoms, confidence in quitting, use of medications, and smoking status. At the 6-month follow-up time point, if a participant self-reports abstinence from smoking, the participant will be asked to complete a survey in-person and provide a sample of end-expired carbon monoxide for biochemical validation. At the 6 month time point, GBC participants who continue to smoke will be offered an additional phone call from the nurse tobacco counselor in which the results of the baseline NMR test will be given, along with a second prescription for a smoking cessation medication based on the NMR results (i.e., single arm crossover design). Two weeks after this additional phone call, the patient will be contacted for a final survey regarding use of medication and smoking status.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Participant, Nurse, and RAs all blinded to random Arm assignment, none blinded to medication prescription
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older
- •Smokes ≥ 5 cigarettes per day
- •Willing to give up all forms of tobacco (5/10/2016 - 6/27/2016)
- •Medically cleared (i.e., no contraindications in Section 3) to receive at least 2 FDA- approved smoking cessation medications
- •Willing to use the medications for which medically cleared (individually, not in combination; only applicable if Medically Cleared = Yes)
排除标准
- •Current diagnosis of schizophrenia, psychosis, active suicidal ideation, dementia, or severe mental retardation
- •Receiving palliative or hospice care
- •Currently pregnant or breastfeeding
- •Hospitalized for a psychiatric condition in the past year (5/10/2016 - 6/27/2016)
- •Hospitalized for a psychiatric condition in the past 3 months or change in psychiatric medications in last 3 months (6/28/2016 forward)
- •Telephone problems that would preclude participation (e.g., can't receive calls reliably)
- •Not able to read and speak English
- •Abstinent from cigarettes for >3 days (b/c NMR not reliable after 72 hours)
- •Used smoking cessation medications in the last 7 days (5/10/2016 - 6/27/2016)
研究组 & 干预措施
Metabolism-Informed Care (MIC)
Smoking Cessation Pharmacotherapy (varenicline, bupropion, and nicotine patch) recommendations were guided by Nicotine Metabolism as measured by the Nicotine Metabolite Ratio. Ultimately, after being educated about smoking cessation medication efficacy and side-effects, the participant could decide to take any medication for which they were medically cleared, but the recommendation was made based on rate of Nicotine Metabolism.
干预措施: Nicotine Metabolite Ratio (Other)
Metabolism-Informed Care (MIC)
Smoking Cessation Pharmacotherapy (varenicline, bupropion, and nicotine patch) recommendations were guided by Nicotine Metabolism as measured by the Nicotine Metabolite Ratio. Ultimately, after being educated about smoking cessation medication efficacy and side-effects, the participant could decide to take any medication for which they were medically cleared, but the recommendation was made based on rate of Nicotine Metabolism.
干预措施: Varenicline (Drug)
Metabolism-Informed Care (MIC)
Smoking Cessation Pharmacotherapy (varenicline, bupropion, and nicotine patch) recommendations were guided by Nicotine Metabolism as measured by the Nicotine Metabolite Ratio. Ultimately, after being educated about smoking cessation medication efficacy and side-effects, the participant could decide to take any medication for which they were medically cleared, but the recommendation was made based on rate of Nicotine Metabolism.
干预措施: Bupropion (Drug)
Metabolism-Informed Care (MIC)
Smoking Cessation Pharmacotherapy (varenicline, bupropion, and nicotine patch) recommendations were guided by Nicotine Metabolism as measured by the Nicotine Metabolite Ratio. Ultimately, after being educated about smoking cessation medication efficacy and side-effects, the participant could decide to take any medication for which they were medically cleared, but the recommendation was made based on rate of Nicotine Metabolism.
干预措施: Nicotine patch (Drug)
Guideline-Based Care (GBC)
Smoking Cessation Pharmacotherapy (varenicline, bupropion, and nicotine patch) was co-selected from those they were medically able to receive after educating participants about smoking cessation medication efficacy and side-effects.
干预措施: Varenicline (Drug)
Guideline-Based Care (GBC)
Smoking Cessation Pharmacotherapy (varenicline, bupropion, and nicotine patch) was co-selected from those they were medically able to receive after educating participants about smoking cessation medication efficacy and side-effects.
干预措施: Bupropion (Drug)
Guideline-Based Care (GBC)
Smoking Cessation Pharmacotherapy (varenicline, bupropion, and nicotine patch) was co-selected from those they were medically able to receive after educating participants about smoking cessation medication efficacy and side-effects.
干预措施: Nicotine patch (Drug)
结局指标
主要结局
Theoretical Endorsement of MIC as assessed by level of agreement to a set of seven 5-point Likert Scale questions
时间窗: Baseline
Likert Scale from Strongly Disagree to Strongly Agree on items assessing attitudes toward and perceptions of using metabolism information to guide medical care
Acceptance of MIC medication recommendation as assessed by concordance between MIC recommendation and actual prescribed medication
时间窗: At 4 weeks post-baseline
Level of agreement between participant's prescribed medication and the medication that would be recommended based on Nicotine Metabolite Ratio
次要结局
- Confidence in Quitting(Baseline - 6 months)
- Medication Use/Compliance(1 - 6 months)
- Smoking Status(6 months)
研究者
Hilary Tindle
Professor of Medicine
Vanderbilt University Medical Center