In Vivo Experience with NRT to Increase Adherence and Smoking Abstinence

使用 NRT 提高依从性和戒烟率的体内经验

• 批准号: 9324175
• 负责人: Karen L Cropsey
• 金额: $ 51.39万
• 依托单位: UNIVERSITY OF ALABAMA AT BIRMINGHAM
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-08-01 至 2021-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9324175
• 关键词: Abstinence; Adherence; American; Behavioral; Bupropion; Cause of Death; Cessation of life; Characteristics; Charge; Communities; Control Groups; Counseling; Country; Criminal Justice; Elements; Expectancy; Exposure to; General Population; Goals; Imprisonment; Individual; Instruction; Intervention; Lead; Legal; Mediating; Mediator of activation protein; Minority; Monitor; Motivation; Nicotine Dependence; Participant; Pharmaceutical Preparations; Pharmacotherapy; Physicians; Population; Prevalence; Public Health; Race; Randomized; Randomized Controlled Trials; Research Personnel; Sampling; Smoke; Smoker; Smoking; Smoking Cessation Intervention; Supervision; System; Testing; Time; United States; Visit; Withdrawal; Withdrawal Symptom; Work; comparative efficacy; disability; disadvantaged population; disparity reduction; expectation; experience; follow-up; health care availability; health disparity; high risk; improved; in vivo; medication compliance; nicotine gum; nicotine patch; nicotine replacement; novel; novel strategies; post intervention; primary outcome; psychoeducational; public health relevance; sex; smoking cessation; standard care; successful intervention; symptomatology; therapy design; treatment effect

 DESCRIPTION (provided by applicant): Smoking remains the leading cause of death and disability in the United States, resulting in death for 1 out of every 2 smokers. While smoking rates have declined to about 18% among the general population, smoking rates still remain disproportionately high among individuals in the criminal justice system (i.e., 70-80%). Despite this high rate of smoking, few interventions have been tested in this population. We were the first to investigate providing 12 weeks of bupropion to a sample of community corrections smokers and then randomizing them to either four sessions of smoking cessation counseling or no counseling to quit. No significant differences were found between our two groups, indicating no additional benefit from more intensive smoking cessation counseling. However, while only 5.8% were abstinent at the 6 month follow-up, abstinence rates were quadrupled among the minority of those who were adherent to medication. Developing interventions to increase medication adherence has been cited as the most important means to reducing disparities; however, the few interventions that have investigated increasing adherence have been psychoeducational only and have yielded poor results. But evidence from our previous work demonstrated that smokers who had previous experience using bupropion had higher subsequent cessation rates and this relationship was mediated by improved medication adherence. Thus, exposure to medication is very likely the critical factor in improving subsequent adherence. The current application proposes a randomized controlled trial to maximize medication adherence with this population of smokers by testing an In Vivo NRT experiential intervention. Participants randomized to the In Vivo intervention will try a nicotine patch in Session 1, try nicotine gum in Session 2, try combination nicotine replacement therapy (cNRT) in Session 3, and discuss any problems with use of cNRT for a quit attempt in Session 4. During each 30-minute session they will discuss their expectations for the medication as well as the In Vivo session effects of these medications on withdrawal symptomatology, including urge to smoke. Between sessions, participants will be given medication to use during that week to make practice quit attempts and to become familiar with the medication. Participants randomized to the control group will receive four 30-minute sessions of standard behavioral counseling. All participants will receive cNRT for 10 weeks. Follow-ups will occur up to six months post-intervention. Primary outcomes include 6 month point prevalence abstinence and abstinence across time as well as medication adherence. If successful, this intervention could provide an easily transportable, novel, and tailored intervention to increase medication adherence and improve smoking cessation rates among smokers in the criminal justice system to reduce health disparities and save lives.

 描述（由申请人提供）：吸烟仍然是美国死亡和残疾的主要原因，每 2 名吸烟者中就有 1 人死亡。虽然普通人群的吸烟率已下降至 18% 左右，但刑事司法系统中个人的吸烟率仍然过高（即 70-80%）。尽管吸烟率很高，但在该人群中测试的干预措施却很少。我们是第一个进行调查的机构，为社区矫正吸烟者样本提供 12 周的安非他酮，然后将他们随机分为四次戒烟咨询或不接受戒烟咨询。我们两组之间没有发现显着差异，表明更深入的戒烟咨询没有额外的好处。然而，虽然在 6 个月的随访中只有 5.8% 的人戒酒，但少数坚持服药的人的戒酒率却翻了两番。制定干预措施以提高药物依从性被认为是减少差异的最重要手段；然而，为数不多的调查提高依从性的干预措施仅限于心理教育，且效果不佳。但我们之前的工作证据表明，有过使用安非他酮经验的吸烟者随后的戒烟率较高，并且这种关系是通过改善药物依从性来调节的。因此，接触药物很可能是提高后续依从性的关键因素。当前的申请提出了一项随机对照试验，通过测试体内 NRT 体验干预措施，最大限度地提高该吸烟者群体的用药依从性。随机接受体内干预的参与者将在第 1 节中尝试尼古丁贴片，在第 2 节中尝试尼古丁口香糖，在第 3 节中尝试联合尼古丁替代疗法 (cNRT)，并在第 4 节中讨论使用 cNRT 进行戒烟尝试的任何问题。在每个 30 分钟的会话中，他们将讨论他们对药物的期望以及这些药物对戒断症状（包括吸烟冲动）的体内会话影响。在课程之间，参与者将获得在该周内使用的药物，以练习戒烟尝试并熟悉药物。随机分配到对照组的参与者将接受四次每次 30 分钟的标准行为咨询。所有参与者都将接受为期 10 周的 cNRT。干预后六个月内将进行随访。主要结局包括 6 个月点的戒断率和随时间的戒断率以及药物依从性。如果成功，这种干预措施可以提供一种易于携带、新颖且量身定制的干预措施，以提高刑事司法系统中吸烟者的用药依从性并提高戒烟率，从而减少健康差距并挽救生命。