Achieving smoking cessation milestones in opioid treatment patients: a randomized 2 x 2 factorial trial of directly observed and long-term varenicline

在阿片类药物治疗患者中实现戒烟里程碑：直接观察和长期伐尼克兰的随机 2 x 2 析因试验

• 批准号: 9634050
• 负责人: Shadi Nahvi
• 金额: $ 68.06万
• 依托单位: ALBERT EINSTEIN COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-04-01 至 2022-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9634050
• 关键词: Abstinence; Achievement; Address; Adherence; Behavioral; Biological Factors; Chronic; Clinical; Clinical Trials; Communities; Data; Directly Observed Therapy; Disease; Double-Blind Method; Enrollment; Evidence based intervention; Funding; HIV/TB; Health; Health Care Costs; Hour; Individual; Intervention; Methadone; Modeling; Motivation; National Institute of Drug Abuse; Nature; Opioid; Outcome; Outpatients; Patients; Persons; Pharmaceutical Preparations; Pharmacogenetics; Pharmacotherapy; Placebos; Prevalence; Process; Psychological Factors; Psychosocial Factor; Randomized; Randomized Controlled Trials; Relapse; Research; Self Administration; Smoker; Smoking; Smoking Cessation Intervention; Substance Use Disorder; Testing; Therapeutic Intervention; Time; Tobacco; Tobacco use; Withholding Treatment; active method; addiction; adherence rate; base; cigarette smoke; comorbidity; double-blind placebo controlled trial; efficacy testing; evidence base; improved; innovation; intervention effect; medication compliance; methadone patient; model design; nicotine replacement; novel; novel strategies; opioid treatment program; opioid use disorder; pilot trial; prevent; psychologic; recruit; skills; smoking cessation; social; social factors; standard care; success; theories; tobacco abstinence; tobacco smokers; treatment effect; varenicline

ABSTRACT Tobacco use and tobacco-related disease are highly prevalent among persons with opioid use disorders (OUD). Unfortunately, traditional evidence-based smoking cessation interventions have yielded low rates of tobacco abstinence in this group. The majority of trials evaluating smoking cessation treatment interventions among persons with OUD have relied on short-term interventions that do not account for the unique challenges faced by these smokers, specifically, establishing initial abstinence, adhering to evidence-based cessation treatments, and maintaining abstinence once active treatments cease. Long-term smoking cessation medication treatment approaches have shown promise in promoting cessation and decreasing relapse among individuals without OUD, however the applicability of extended medication approaches to smokers with OUD may be limited by poor adherence to smoking cessation medications. Though adherence to cessation medication is strongly associated with cessation success, adherence is especially challenging for persons with OUD. Opioid treatment program-based directly observed therapy (DOT) interventions improve clinical outcomes in HIV and TB, and our pilot data suggest that DOT varenicline is associated with increased smoking cessation medication adherence and may increase smoking cessation rates. We therefore propose a 2 x 2 factorial, randomized, double-blind, placebo-controlled trial to efficiently test two interventions: directly observed medication therapy, and long-term therapy with varenicline. Our analytic strategy will evaluate the milestones in smoking cessation—achieving initial abstinence, preventing lapse and preventing relapse-- necessary for long-term cessation, and evaluate theoretically-guided psychological and social factors and pharmacogenetic factors that influence these cessation processes. We will recruit 450 smokers with OUD from community-based, outpatient opioid treatment programs and test the following specific aims: (1) to test the efficacy of directly observed varenicline therapy compared to self-administered varenicline therapy on smoking cessation milestones, (2) to test the efficacy of long-term varenicline compared to short-term varenicline on smoking cessation milestones, and (3) to understand the mechanism of smoking cessation by examining the impact of theory-guided psychological and social factors and of pharmacogenetic factors on cessation milestones. This proposal is innovative, and addresses the challenges of both promoting and maintaining tobacco abstinence among smokers with OUD.

抽象的 烟草使用和烟草相关疾病在阿片类药物使用障碍患者中非常普遍 （乌德琴）。不幸的是，传统的循证戒烟干预措施的成功率很低。 该组的戒烟情况。大多数试验评估戒烟治疗干预措施 患有 OUD 的人依赖短期干预措施，但没有考虑到独特的挑战 这些吸烟者面临的问题，特别是建立初步戒烟，坚持循证戒烟 治疗，并在积极治疗停止后保持禁欲。长期戒烟 药物治疗方法已显示出在促进戒烟和减少复发方面的希望 没有 OUD 的个体，但是延长用药方法对患有 OUD 的吸烟者的适用性 可能因戒烟药物依从性差而受到限制。虽然坚持戒烟 药物治疗与戒烟成功密切相关，对于患有此病的人来说，坚持治疗尤其具有挑战性 沉香木。基于阿片类药物治疗计划的直接观察治疗 (DOT) 干预措施改善临床 HIV 和结核病的结果，我们的试点数据表明 DOT 伐尼克兰与吸烟增加有关 戒烟药物的依从性可能会提高戒烟率。因此我们建议采用 2 x 2 析因、随机、双盲、安慰剂对照试验，有效测试两种干预措施：直接 观察药物治疗和伐尼克兰长期治疗。我们的分析策略将评估 戒烟的里程碑——实现初步戒烟、预防戒烟和预防复发—— 长期戒烟所必需的，并评估理论指导的心理和社会因素 影响这些戒烟过程的药物遗传学因素。我们将从以下地区招募 450 名使用 OUD 的吸烟者： 基于社区的门诊阿片类药物治疗方案并测试以下具体目标：（1）测试 直接观察伐尼克兰治疗与自我给药伐尼克兰治疗对吸烟的疗效比较 戒烟里程碑，(2) 测试长期伐尼克兰与短期伐尼克兰的疗效比较 戒烟里程碑，(3) 通过检查戒烟的机制来了解戒烟的机制 理论指导的心理和社会因素以及药物遗传因素对戒烟的影响 里程碑。该提案具有创新性，解决了促进和维持的挑战 使用 OUD 的吸烟者戒烟。