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，导致每2名吸烟者中就有1人死亡。虽然吸烟率已下降到约18%的一般人口，吸烟率仍然不成比例地高的个人在刑事司法系统（即，70-80%）。尽管吸烟率很高，但在这一人群中测试的干预措施很少。我们是第一个调查提供12周的安非他酮的社区矫正吸烟者的样本，然后随机将他们分为四个阶段的戒烟咨询或没有咨询戒烟。我们两组之间没有发现显著差异，表明更密集的戒烟咨询没有额外的好处。然而，虽然在6个月随访时只有5.8%的人禁欲，但在少数坚持服药的人中，禁欲率是原来的四倍。发展干预措施，以增加药物治疗的依从性被认为是减少差距的最重要手段;然而，少数干预措施，调查增加依从性一直心理教育，并取得了很好的效果。但我们以前的研究表明，有使用安非他酮经验的吸烟者随后的戒烟率更高，这种关系是通过改善药物依从性来介导的。因此，药物暴露很可能是改善后续依从性的关键因素。本申请提出了一项随机对照试验，以通过测试体内NRT经验性干预来最大限度地提高该吸烟人群的药物依从性。随机分配至体内干预的受试者将在第1阶段尝试尼古丁贴片，在第2阶段尝试尼古丁口香糖，在第3阶段尝试联合尼古丁替代疗法（cNRT），并在第4阶段讨论使用cNRT尝试戒烟的任何问题。在每30分钟的会议期间，他们将讨论他们对药物的期望以及这些药物对戒断性精神病的体内影响，包括吸烟欲望。在两次会议之间，参与者将获得药物，在那一周内使用，以进行实践戒烟尝试，并熟悉药物。随机分配到对照组的参与者将接受四次30分钟的标准行为咨询。所有参与者将接受为期10周的cNRT。随访将在干预后6个月内进行。主要结局包括6个月时点的患病率、戒断率和不同时间的戒断率以及药物依从性。如果成功，这种干预可以提供一种易于运输，新颖和量身定制的干预措施，以增加药物依从性并提高刑事司法系统中吸烟者的戒烟率，以减少健康差距并挽救生命。