Contingency Management for Initiating Smoking Abstinence

开始戒烟的应急管理

• 批准号: 7440110
• 负责人: William Barry White
• 金额: $ 57.85万
• 依托单位: UNIVERSITY OF CONNECTICUT SCH OF MED/DNT
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-09-30 至 2013-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7440110
• 关键词: Abate; Abstinence; Aftercare; Age; Agonist; Attenuated; Behavior Therapy; Blood Pressure; Carbon Monoxide; Cigarette; Clinic; Clinical; Cognitive Therapy; Combined Modality Therapy; Condition; Cotinine; Daily; Dose; Drug usage; Effectiveness; Event; Health Status; Heart Rate; Hour; Hypertension; Intervention; Lead; Left; Link; Long-Term Effects; Mediating; Monitor; Motivation; Nicotine; Outcome; Outcome Measure; Patients; Pharmaceutical Preparations; Pharmacotherapy; Population; Prevalence; Prize; Psychological reinforcement; Publishing; Randomized; Range; Rate; Reading; Relapse; Sampling; Self Efficacy; Services; Smoke; Smoker; Smoking; Staging; Standards of Weights and Measures; Sum; Techniques; Therapeutic Effect; Time; Week; Withdrawal; Withdrawal Symptom; behavior change; blood pressure regulation; cardiovascular risk factor; clinically significant; contingency management; cost; cost effectiveness; day; follow-up; improved; indexing; nicotine craving; nicotinic receptor beta2; novel; receptor; reinforcer; response; smoking cessation; success; varenicline; voucher; ward

DESCRIPTION (provided by applicant): Contingency management (CM) treatments can reduce smoking. This study will evaluate the efficacy of a short-term CM technique for initiating abstinence in conjunction with the nicotine receptor agonist/antagonist varenicline. While efficacious in reducing smoking rates, about half of patients do not respond to this pharmacotherapy, and most of the response (or lack thereof) occurs in the first month. CM is especially effective in engendering initial abstinence; if CM can improve early response to varenicline; more patients may remain on the drug and achieve abstinence, which in turn should be associated with long-term benefits. This drug may be particularly amenable for use with CM because it is purported to attenuate nicotine craving and withdrawal, two effects that do not occur with CM alone. Further, by providing CM with varenicline in a high cardiovascular risk population (patients with hypertension who smoke), benefits may outweigh costs. In total, 260 patients with pre- and stage I hypertension who smoke >10 cigarettes per day will be randomized to: varenicline alone or varenicline plus CM. Patients in both conditions will receive varenicline (titrated to a maximal dose of 1.0 mg twice daily) for 12 weeks along with standard smoking cessation therapy and regular carbon monoxide (CO) and cotinine monitoring. Patients assigned to CM will earn chances to win prizes ranging in value from $1 to $100 for each CO negative (<6 ppm) sample provided, and samples negative for cotinine will result in even greater chances to earn prizes. Main outcomes will be 7-day point prevalence rates of objectively confirmed abstinence at weeks 5, 12, 24, 36, and 52, longest duration of continuous abstinence, and percent continuously abstinent. A significantly higher proportion of CM patients are expected to achieve and maintain long durations of abstinence than patients receiving varenicline alone. Although some relapse is likely to occur after treatment, slopes of the relapse curves are not expected to differ between groups, such that the group that receives CM early on should have a higher proportion of patients abstinent at week 52. Clinic and 24-hour blood pressure (BP) and heart rate (HR) will be additional outcomes. We expect that BP and HR will decrease more among CM than non-CM patients and reductions in smoking may mediate decreases in these indices.

描述（由申请人提供）：应急管理（CM）治疗可以减少吸烟。这项研究将评估短期CM技术与尼古丁受体激动剂/拮抗剂varenicline结合使用的戒酒功效。尽管有效降低吸烟率，但大约一半的患者对这种药物疗法没有反应，并且大部分反应（或缺乏反应）发生在第一个月。 CM在引发最初的戒酒方面特别有效。如果CM可以改善对Varenicline的早期反应；越来越多的患者可能会保留该药物并戒酒，这反过来应与长期福利有关。该药物可能特别适合与CM一起使用，因为据称它可以减轻尼古丁的渴望和戒断，这两种效果仅在CM中不会出现。此外，通过在高心血管风险人群（吸烟的高血压患者）中为CM提供varenicline，收益可能会超过成本。总共有260例I高血压前和I期高血压患者，每天吸烟> 10支香烟将被随机分配为：单独使用Varenicline或Varenicline加上CM。这两种情况下的患者将接受varenicline（每天两次滴定至最大剂量为1.0 mg），共12周，以及标准的戒烟疗法以及常规的一氧化碳（CO）和可替宁监测。分配给CM的患者将获得赢得奖品的机会，其价值从$ 1到$ 100不等，每个CO负面样本（<6 ppm）样本，Cotinine的样本将导致更大的机会赚取奖品。主要结果将是在第5、12、24、36和52周客观确认的节制的7天点患病率，连续禁欲的最长持续时间和持续戒酒的百分比。与仅接受VarenIcline的患者相比，预期CM患者比例明显更高的CM患者将达到和维持长期的禁欲时间。尽管治疗后可能会发生一些复发，但预计复发曲线的斜率不会有所不同，因此，早期接受CM的组应在第52周戒酒的患者中应更高比例。我们预计，与非CM患者相比，CM的BP和HR会减少更多，而吸烟的减少可能会介导这些指数的减少。