Cardiovascular, Immune and Psychosocial Benefits of Reduced Cocaine Use

减少可卡因使用对心血管、免疫和社会心理的益处

• 批准号: 9469852
• 负责人: William Walton Stoops
• 金额: $ 62.54万
• 依托单位: UNIVERSITY OF KENTUCKY
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-09-01 至 2022-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9469852
• 关键词: Abnormal Cell; Abstinence; Adopted; Adoption; Aftercare; Alcohol dependence; Atherosclerosis; Behavior; Behavioral; Biochemical; Biological Markers; Blood Platelets; Blood Pressure; Cardiovascular Physiology; Cardiovascular system; Cellular Immunity; Chronic; Clinical; Clinical Trials; Cocaine; Cognitive; Comorbidity; Contracts; Control Groups; Counseling; Data; Delayed Hypersensitivity; Diagnosis; Disease; Dose; Drug Use Disorder; Drug usage; Eating; Endothelin-1; Fatty acid glycerol esters; Foundations; Frequencies; Health; Heart Rate; Heavy Drinking; Hypertension; Immune; Immunologic Markers; Incentives; Individual; Infection; Inflammatory; Intervention; Knowledge; Life Style; Measures; Mediating; Medical; Mental Health; Myocardial Infarction; Outcome; Patient Self-Report; Physiological; Problem behavior; Randomized; Research; Risk; Risk Behaviors; Standardization; Stress Tests; Stroke; TNF gene; TNFSF5 gene; Toxic effect; Treatment Efficacy; Unemployment; Vasospasm; active method; alcohol use disorder; behavioral pharmacology; biopsychosocial; clinical practice; cocaine use; expectation; experience; financial incentive; fitness; follow-up; immune function; improved; innovation; prevent; prospective; psychosocial; response; success; therapy development; treadmill; vasoconstriction; week trial

ABSTRACT Promoting reductions in problem behaviors is common in medical practice wherein at-risk individuals are counseled to make moderate, sustainable changes in lifestyle. Reducing the percentage of heavy drinking days in individuals with alcohol use disorder is an accepted intervention target in alcohol addiction treatment, yet for other drug use disorders, complete abstinence remains the standard for demonstrating treatment efficacy. Interventions that promote reductions in drug use should improve biopsychosocial outcomes. Little research has been conducted to demonstrate benefits of reduced drug use, however. Demonstrating the benefits of reduced cocaine (COC) use would significantly advance treatment development by challenging expectations for outcomes from possible interventions. COC use produces a number of biopsychosocial detriments (e.g., cardiovascular toxicity, disrupted immune function, increased psychiatric comorbidities) that could be ameliorated by COC use reduction. No studies have prospectively or comprehensively evaluated this possibility to date, although preliminary data support this hypothesis. To fill this critical knowledge gap, we propose a randomized, controlled 12-week trial in which financial incentives will be used to reduce COC use. Subjects will be randomly assigned to one of three groups (n=66 completers/ group): 1) high value financial incentives for COC abstinence in which frequency of COC use is expected to be substantially reduced or completely eliminated, 2) low value financial incentives for COC abstinence in which frequency of COC use is expected to be reduced or 3) a non-contingent control group, in which frequency of COC use is expected to remain stable. This study aims to demonstrate that reduced COC use improves physiological and biochemical indicators of cardiovascular and immune fitness, as well as psychosocial function. The overarching hypothesis is that individuals assigned to the active treatment conditions will display improvements in biopsychosocial domains compared to individuals assigned to the non-contingent control group. A “dose-response” is also expected whereby individuals assigned to the high value condition will display greater reductions in COC use, and consequently greater improvements, relative to the low value condition. This research will advance the field by: 1) using multifaceted health outcomes to provide prospective evidence supporting reduced drug use as a viable endpoint for COC treatment development, 2) identifying biochemical indicators of health improvements associated with reduced COC use and 3) laying the foundation for a paradigm-shifting definition of COC treatment success, thereby challenging expectations for outcomes in behavioral and pharmacological intervention development. These innovations will accelerate identification of promising treatments for cocaine use disorder, resulting in a sustained and powerful impact on scientific and clinical practice.

抽象的 促进问题行为的减少在医疗实践中很常见 被计数以进行生活方式中等，可持续的变化。减少大量饮酒的百分比 酒精使用障碍患者的天数是酒精成瘾治疗中公认的干预措施， 然而，对于其他药物使用障碍，完全禁欲仍然是证明治疗的标准 功效。促进药物使用的干预措施应改善生物心理社会结局。小的 但是，已经进行了研究以证明降低药物使用的好处。展示 减少可卡因（COC）使用的好处将通过挑战显着提高治疗的发展 对可能的干预措施的结果的期望。 COC使用产生许多生物心理社会 损害（例如心血管毒性，免疫功能中断，精神病合并症增加） COC使用减少可以改善。没有研究对此进行了前瞻性或全面评估 迄今为止的可能性，尽管初步数据支持了这一假设。为了填补这个关键的知识差距，我们 提案一项随机控制的12周试验，其中将使用经济激励措施来减少COC使用。 受试者将随机分配给三组之一（n = 66个完成者/组）：1）高价值财务 COC禁欲的激励措施，其中预计COC使用频率将大大降低或 完全消除，2）COC禁欲的低价值经济激励措施，其中COC使用的频率为 预计将减少或3）一个非固定对照组，其中COC使用的频率有望 保持稳定。这项研究旨在证明减少COC使用可以改善物理和生化 心血管和免疫适应性以及社会心理功能的指标。总体假设 是分配给主动治疗条件的个人将显示生物心理社会的改善 与分配给非束缚对照组的个体相比。 “剂量反应”也是 预期分配给高价值条件的个人将显示出更大的COC使用减少， 因此，相对于低价值条件，更大的改进。这项研究将推动 字段作者：1）使用多方面的健康结果提供支持减少药物使用的前瞻性证据 作为COC治疗开发的可行终点，2）确定健康的生化指标 与减少COC使用相关的改进和3）为范式转移定义奠定基础 COC治疗成功，从而挑战了对行为和药理结果的预期 干预开发。这些创新将加速可卡因的承诺治疗 使用障碍，导致对科学和临床实践的持续和强大的影响。