546 Using Contingency Management to Understand the Cardiovascular, Immune and Psychosocial Benefits of Reduced Cocaine Use: A Protocol for a Randomized Controlled Trial

Sean D. Regnier, Jennifer R. Havens, Thomas P. Shellenberg, David H. Cox, Thomas S. Baker, J. Lile, C. Rush, Reuben Adatorwovor, L. Hays, Danielle M. Anderson, Mary B. Fisher, S. Segerstrom, Joy M. Schmitz, W. Stoops
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Abstract

OBJECTIVES/GOALS: Contingency management (CM) procedures yield measurable reductions in cocaine use. This poster describes a trial aimed at using CM as a vehicle to show the biopsychosocial health benefits of reduced use, rather than total abstinence, the currently accepted metric for treatment efficacy. METHODS/STUDY POPULATION: In this 12-week, randomized controlled trial, CM was used to reduce cocaine use and evaluate associated improvements in cardiovascular, immune, and psychosocial well-being. Adults aged 18 and older who sought treatment for cocaine use (N=127) were randomized into three groups in a 1:1:1 ratio: High Value ($55) or Low Value ($13) CM incentives for cocaine-negative urine samples or a non-contingent control group. They completed outpatient sessions three days per week across the 12-week intervention period, totaling 36 clinic visits and four post-treatment follow-up visits. During each visit, participants provided observed urine samples and completed several assays of biopsychosocial health. RESULTS/ANTICIPATED RESULTS: Preliminary findings from generalized linear mixed effect modeling demonstrate the feasibility of the CM platform. Abstinence rates from cocaine use were significantly greater in the High Value group (47% negative; OR = 2.80; p = 0.01) relative to the Low Value (23% negative) and Control groups (24% negative;). In the planned primary analysis, the level of cocaine use reduction based on cocaine-negative urine samples will serve as the primary predictor of cardiovascular (e.g., endothelin-1 levels), immune (e.g., IL-10 levels) and psychosocial (e.g., Addiction Severity Index) outcomes using results from the fitted models. DISCUSSION/SIGNIFICANCE: This research will advance the field by prospectively and comprehensively demonstrating the beneficial effects of reduced cocaine use. These outcomes can, in turn, support the adoption of reduced cocaine use as a viable alternative endpoint in cocaine treatment trials.
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546 利用权变管理了解减少使用可卡因对心血管、免疫和社会心理的益处:随机对照试验方案
目的/目标:权宜管理(CM)程序可显著减少可卡因的使用。本海报介绍了一项试验,该试验旨在利用 "权宜管理 "作为载体,展示减少使用可卡因带来的生物心理社会健康益处,而不是目前公认的衡量治疗效果的标准--完全戒断。方法/研究对象:在这项为期 12 周的随机对照试验中,中药被用来减少可卡因的使用,并评估相关的心血管、免疫和社会心理健康改善情况。因吸食可卡因而寻求治疗的 18 岁及以上成年人(127 人)按 1:1:1 的比例被随机分为三组:可卡因阴性尿样的高价值(55 美元)或低价值(13 美元)CM 奖励组或非条件对照组。在为期 12 周的干预期间,他们每周三天完成门诊治疗,共计 36 次门诊和 4 次治疗后随访。每次就诊时,参与者都要提供观察到的尿样,并完成几项生物心理社会健康检测。结果/预期结果:广义线性混合效应模型的初步研究结果表明,CM 平台是可行的。相对于低价值组(23% 为阴性)和对照组(24% 为阴性),高价值组的可卡因戒断率明显更高(47% 为阴性;OR = 2.80;P = 0.01)。在计划进行的主要分析中,根据可卡因阴性尿样得出的可卡因使用减少水平将作为心血管(如内皮素-1 水平)、免疫(如 IL-10 水平)和社会心理(如成瘾严重程度指数)结果的主要预测指标,并使用拟合模型得出的结果。讨论/意义:这项研究通过前瞻性地全面展示减少可卡因使用的有益效果,将推动该领域的发展。这些结果反过来又能支持在可卡因治疗试验中采用减少可卡因使用量作为可行的替代终点。
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