Treatment of smoking lapses and relapses

戒烟和复吸的治疗

• 批准号: 8231841
• 负责人: JOHN R HUGHES
• 金额: $ 59.6万
• 依托单位: UNIVERSITY OF VERMONT & ST AGRIC COLLEGE
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-07-01 至 2015-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8231841
• 关键词: Abstinence; Adverse event; Aftercare; Behavioral Mechanisms; Cigarette; Confusion; Counseling; Dose; FDA approved; Guidelines; Heroin Users; Incidence; Instruction; Intervention; Label; Mails; Mediating; Methods; Nicotine; Outcome; Participant; Pharmaceutical Preparations; Psychological reinforcement; Randomized; Randomized Controlled Trials; Recommendation; Relapse; Rewards; Self Efficacy; Serious Adverse Event; Smoker; Smoking; Telephone; Testing; Time; Training Programs; Treatment Failure; Voice; Withdrawal; Writing; common treatment; craving; follow-up; nicotine replacement; psychosocial; response; smoking cessation; success

DESCRIPTION (provided by applicant): Over-the-counter nicotine replacement therapy (OTC NRT) is, by far, the most common treatment for smoking cessation in the US. Over 80% of those using NRT will lapse and return to smoking. One possible reason for this high rate of treatment failure is that smokers are instructed to stop medication when they lapse (in contrast to recommendations to increase medication dose when heroin users lapse). Recent indirect evidence suggests that, in fact, a lapse is the most important time to continue NRT. We propose a randomized controlled trial of continued NRT post-lapse vs. stopping NRT post- lapse. Smokers who want to quit will receive, counseling, stop abruptly and begin NRT. All psychosocial treatment will occur via phone and medications via mail. Instructions and rationales for continuing or stopping NRT during a lapse episode will be delivered via written material, Interactive Voice Response (IVR) phone messages and reinforced during phone counseling. We will enter 1000 smokers and anticipate observing 580 lapses while using NRT. We hypothesize our intervention to continue NRT use upon a lapse will increase 6 month point prevalent abstinence with an OR of 2.0. We will also examine compliance with instructions and possible behavioral mechanisms of efficacy (e.g. does continued NRT reduce nicotine reward from cigarettes) as well as the incidence of serious adverse events when participants are concurrently smoking and using NRT after a lapse. This study will be the first direct experimental test of whether continuing NRT after a relapse increases abstinence and is safe. Positive results would suggest the package instructions for NRT, treatment guidelines and training programs should change to explicitly encourage smokers to continue NRT treatment after a lapse. PUBLIC HEALTH RELEVANCE: Many smokers who try to stop smoking with NRT lapse. Currently, FDA-approved package labeling tells smokers who lapse while using NRT to stop NRT immediately; however, several indirect lines of evidence suggest continuing NRT upon a lapse dramatically increases success and is safe. Our study will be the first direct experimental test of whether continuing NRT after a relapse increases abstinence and is safe. Positive results would suggest the package instructions for NRT should change and that clinicians need to instruct smokers to continue NRT treatment after lapse.

描述（由申请人提供）：到目前为止，非处方尼古丁替代疗法（OTC NRT）是美国最常见的戒烟治疗。超过80%的使用NRT的人会失效并重新吸烟。治疗失败率如此之高的一个可能原因是，吸烟者被指示在他们失败时停止药物治疗（与海洛因使用者失败时增加药物剂量的建议相反）。最近的间接证据表明，事实上，一个失误是最重要的时间继续NRT。我们提出了一项随机对照试验，比较失效后继续NRT与失效后停止NRT。想戒烟的吸烟者将接受咨询，突然戒烟并开始NRT。所有的心理治疗都将通过电话进行，药物治疗通过邮件进行。将通过书面材料、交互式语音应答（IVR）电话留言提供在失效事件期间继续或停止NRT的说明和理由，并在电话咨询期间予以加强。我们将入组1000名吸烟者，预计在使用NRT时观察到580例失误。我们假设我们的干预措施在失效后继续使用NRT将增加6个月时的普遍禁欲率，OR为2.0。我们还将检查对说明的依从性和可能的有效性行为机制（例如，持续NRT是否会减少香烟的尼古丁奖励），以及当参与者同时吸烟并在失效后使用NRT时严重不良事件的发生率。这项研究将是第一个直接的实验测试是否继续NRT复发后增加禁欲和安全。积极的结果表明，NRT的包装说明、治疗指南和培训计划应该改变，以明确鼓励吸烟者在失效后继续NRT治疗。 公共卫生相关性：许多吸烟者试图戒烟，但NRT失效。目前，FDA批准的包装标签告诉在使用NRT时失效的吸烟者立即停止NRT;然而，一些间接证据表明，在失效后继续NRT会显著增加成功率，并且是安全的。我们的研究将是第一个直接的实验测试，以确定复发后继续NRT是否会增加禁欲并且安全。阳性结果表明NRT的包装说明应该改变，临床医生需要指导吸烟者在失效后继续NRT治疗。