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Clinical effects beyond cocaine use of sustained‐release dexamphetamine for the treatment of cocaine dependent patients with comorbid opioid dependence: Secondary analysis of a double‐blind, placebo‐controlled randomised trial
Addiction ( IF 6 ) Pub Date : 2020-05-01 , DOI: 10.1111/add.14874
Peter Blanken 1 , Mascha Nuijten 1 , Wim van den Brink 2 , Vincent M Hendriks 1, 3
Affiliation  

BACKGROUND AND AIMS Sustained-release (SR) formulations of dexamphetamine and mixed amphetamine salts have shown positive effects in the treatment of patients with a cocaine use disorder. We previously demonstrated the efficacy of SR-dexamphetamine for patients with cocaine dependence in terms of cocaine use reductions. In this secondary analysis, we assessed whether SR-dexamphetamine treatment also improves the health status of these patients. DESIGN Multi-centre randomized, double-blind placebo-controlled trial. SETTING Four supervised heroin-assisted treatment (HAT) out-patient clinics in the Netherlands. In HAT, methadone treatment-refractory opioid-dependent patients can self-administer individually titrated doses of pharmaceutical grade diacetylmorphine, coprescribed with oral methadone. PARTICIPANTS Seventy-three cocaine-dependent patients (90% males; average age = 48.7 years), participating in HAT for their treatment-refractory comorbid opioid dependence. INTERVENTIONS Twelve weeks pharmacotherapy with once-daily, supervised intake of two tablets of SR-dexamphetamine (2 × 30 mg/day) or two identical placebo tablets. MEASUREMENTS Assessment every 4 weeks: cocaine use (time-line follow-back), physical health (Maudsley Addiction Profile-Health Symptoms Scale), mental health (Brief Symptom Inventory) and illegal activities (Addiction Severity Index). Primary outcome was 'overall health', a dichotomous, multi-domain response index based on physical health, mental health and social functioning. FINDINGS Compared with placebo, SR-dexamphetamine resulted in larger increases in the number of cocaine abstinent days (P = 0.004) and the proportion of overall health treatment responders (P = 0.045) from the 4 weeks preceding baseline to the final 4 weeks of treatment. While the number of cocaine abstinent days was not associated with overall health in the total study sample, it was positively associated with overall health among patients in poor overall health at the start of SR-dexamphetamine treatment (n = 50), i.e. patients with the potential to improve on this multi-domain response index (odds ratio = 1.076; 95% confidence interval = 1.025-1.130). CONCLUSIONS SR-dexamphetamine reduces cocaine use and may improve clinically relevant health-related outcomes in patients with cocaine dependence who are participating in heroin-assisted treatment for their comorbid heroin dependence.

中文翻译:

使用缓释右旋苯丙胺治疗可卡因依赖患者并伴有阿片类药物依赖的可卡因以外的临床效果:一项双盲、安慰剂对照随机试验的二次分析

背景和目的 右旋苯丙胺和混合苯丙胺盐的缓释 (SR) 制剂在可卡因使用障碍患者的治疗中显示出积极的效果。我们之前证明了 SR-dexamphetamine 在减少可卡因使用方面对可卡因依赖患者的疗效。在此二级分析中,我们评估了 SR-右旋苯丙胺治疗是否也改善了这些患者的健康状况。设计 多中心随机、双盲安慰剂对照试验。地点 荷兰的四家受监督的海洛因辅助治疗 (HAT) 门诊诊所。在 HAT 中,美沙酮治疗难治性阿片类药物依赖患者可以自我给药单独滴定剂量的药物级二乙酰吗啡,与口服美沙酮共同处方。参与者 73 名可卡因依赖患者(90% 为男性;平均年龄 = 48.7 岁),参与 HAT 以治疗其难治性共病阿片类药物依赖。干预 12 周药物治疗,每天一次,在监督下摄入两片 SR-右旋苯丙胺(2 × 30 毫克/天)或两片相同的安慰剂片。测量 每 4 周评估一次:可卡因使用(时间线跟踪)、身体健康(莫兹利成瘾概况 - 健康症状量表)、心理健康(简要症状清单)和非法活动(成瘾严重程度指数)。主要结果是“整体健康”,这是一个基于身体健康、心理健康和社会功能的二分、多领域反应指数。结果 与安慰剂相比,SR-右旋安非他明导致可卡因戒断天数增加更多(P = 0. 004) 和从基线前 4 周到治疗的最后 4 周的整体健康治疗反应者的比例 (P = 0.045)。虽然在整个研究样本中,可卡因戒断天数与整体健康状况无关,但它与 SR-右旋苯丙胺治疗开始时整体健康状况不佳的患者(n = 50)的整体健康状况呈正相关,即患有改进此多域响应指数的潜力(优势比 = 1.076;95% 置信区间 = 1.025-1.130)。结论 SR-右旋苯丙胺可减少可卡因的使用,并可能改善参与海洛因辅助治疗的可卡因依赖患者的临床相关健康相关结果。045) 从基线前 4 周到治疗的最后 4 周。虽然在整个研究样本中,可卡因戒断天数与整体健康状况无关,但它与 SR-右旋苯丙胺治疗开始时整体健康状况不佳的患者(n = 50)的整体健康状况呈正相关,即患有改进此多域响应指数的潜力(优势比 = 1.076;95% 置信区间 = 1.025-1.130)。结论 SR-右旋苯丙胺可减少可卡因的使用,并可能改善参与海洛因辅助治疗的可卡因依赖患者的临床相关健康相关结果。045) 从基线前 4 周到治疗的最后 4 周。虽然在整个研究样本中,可卡因戒断天数与整体健康状况无关,但它与 SR-右旋苯丙胺治疗开始时整体健康状况不佳的患者(n = 50)的整体健康状况呈正相关,即患有改进此多域响应指数的潜力(优势比 = 1.076;95% 置信区间 = 1.025-1.130)。结论 SR-右旋苯丙胺可减少可卡因的使用,并可能改善参与海洛因辅助治疗的可卡因依赖患者的临床相关健康相关结果。它与 SR-右旋苯丙胺治疗开始时整体健康状况不佳的患者的整体健康状况呈正相关(n = 50),即有可能改善该多域反应指数的患者(优势比 = 1.076;95% 置信度)间隔 = 1.025-1.130)。结论 SR-右旋苯丙胺可减少可卡因的使用,并可能改善参与海洛因辅助治疗的可卡因依赖患者的临床相关健康相关结果。它与 SR-右旋苯丙胺治疗开始时整体健康状况不佳的患者的整体健康状况呈正相关(n = 50),即有可能改善该多域反应指数的患者(优势比 = 1.076;95% 置信度)间隔 = 1.025-1.130)。结论 SR-右旋苯丙胺可减少可卡因的使用,并可能改善参与海洛因辅助治疗的可卡因依赖患者的临床相关健康相关结果。
更新日期:2020-05-01
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