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: 9127430
• 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/9127430
• 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 Status; Mediating; Mediator of activation protein; Minority; Monitor; 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; smoking intervention; 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(申请人提供)：吸烟仍然是美国死亡和残疾的主要原因，每2个吸烟者中就有1人死亡。虽然普通人群的吸烟率已降至18%左右，但刑事司法系统中的个人吸烟率仍然过高(即70%至80%)。尽管吸烟率很高，但很少有干预措施在这一人群中进行测试。我们是第一个研究给社区矫正吸烟者提供12周安非他酮的样本，然后将他们随机分成四组，要么接受戒烟咨询，要么不接受戒烟咨询。我们两组之间没有发现显著的差异，这表明更密集的戒烟咨询没有额外的好处。然而，虽然在6个月的随访中只有5.8%的人禁欲，但在少数坚持服药的人中，禁酒率增加了四倍。制定干预措施以提高服药依从性被认为是减少差异的最重要手段；然而，研究服药依从性增加的少数干预措施仅是心理教育，效果不佳。但我们之前工作的证据表明，以前有使用安非他酮经验的吸烟者随后戒烟率更高，这种关系是通过改善用药依从性来调节的。因此，接触药物很可能是改善后续依从性的关键因素。目前的应用提出了一项随机对照试验，通过测试体内NRT经验性干预，最大限度地提高吸烟者对药物的依从性。随机参加体内干预的参与者将在第一阶段尝试尼古丁贴片，在第二阶段尝试尼古丁口香糖，在第三阶段尝试联合尼古丁替代疗法(CNRT)，并在第四阶段讨论在戒烟尝试中使用CNRT的任何问题。在每30分钟的治疗过程中，他们将讨论他们对药物的期望以及这些药物对戒断症状的体内影响，包括吸烟冲动。在疗程之间，参与者将被给予药物，以便在那一周内使用，以使练习戒烟尝试，并熟悉药物。被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。干预后将进行长达六个月的随访。主要结果包括6个月的时点患病率、禁欲和随时间推移的禁欲以及服药依从性。如果成功，这种干预措施可以提供一种易于携带的、新颖的、量身定制的干预措施，以提高刑事司法系统中吸烟者的服药依从性和戒烟率，以减少健康差距和拯救生命。