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.

摘要 促进问题行为的减少在医疗实践中是常见的，其中有风险的个体是 建议在生活方式上做出适度的、可持续的改变。减少大量饮酒的比例 在酒精使用障碍的个体中的30天是酒精成瘾治疗中公认的干预目标， 然而，对于其他药物使用障碍，完全戒断仍然是证明治疗的标准 功效促进减少吸毒的干预措施应改善生物心理社会结果。小 然而，已经进行了研究，以证明减少吸毒的好处。展示 减少可卡因（COC）使用的好处将通过挑战 对可能的干预措施的预期结果。COC的使用产生了一些生物心理社会 附件（例如，心血管毒性、免疫功能紊乱、精神并发症增加）， 可以通过减少COC的使用来改善。没有研究前瞻性或全面评估这一点 这一假设是有可能的，尽管初步数据支持这一假设。为了填补这一关键的知识空白，我们 建议进行一项为期12周的随机对照试验，其中将使用经济激励措施来减少COC的使用。 受试者将被随机分配到三组之一（n=66名完成者/组）：1）高价值财务 COC戒烟激励措施，其中COC使用频率预计将大幅降低，或 完全消除，2）COC禁欲的低价值经济奖励，其中COC使用频率 或3）非或有控制组，其中COC的使用频率预计将 保持稳定。本研究旨在证明减少COC的使用可以改善生理和生化 心血管和免疫健康的指标，以及心理社会功能。总体假设 被分配到积极治疗条件的个体将在生物心理社会方面表现出改善， 域相比，个人分配到非应急控制组。“剂量反应”也是 预期分配到高值条件的个体将显示COC使用的更大减少， 从而相对于低值条件有更大的改进。这项研究将推动 1）利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; 3）为范式转变定义奠定基础 COC治疗成功，从而挑战了对行为和药理学结果的期望， 干预发展。这些创新将加速确定有前途的可卡因治疗方法 使用障碍，对科学和临床实践产生持续而强大的影响。