Parnassia Addiction Research Centre (PARC), Brijder Verslavingszorg, The Hague, the Netherlands.
Department of Psychiatry, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.
Addiction. 2020 May;115(5):917-923. doi: 10.1111/add.14874. Epub 2020 Jan 6.
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.
Multi-centre randomized, double-blind placebo-controlled trial.
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.
Seventy-three cocaine-dependent patients (90% males; average age = 48.7 years), participating in HAT for their treatment-refractory comorbid opioid dependence.
Twelve weeks pharmacotherapy with once-daily, supervised intake of two tablets of SR-dexamphetamine (2 × 30 mg/day) or two identical placebo tablets.
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.
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).
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.
持续释放(SR)制剂的右旋苯丙胺和混合苯丙胺盐已显示出对可卡因使用障碍患者的治疗有积极作用。我们之前已经证明了 SR-右旋苯丙胺在减少可卡因使用方面对可卡因依赖患者的疗效。在这项二次分析中,我们评估了 SR-右旋苯丙胺治疗是否也能改善这些患者的健康状况。
多中心随机、双盲安慰剂对照试验。
荷兰四家监督下的海洛因辅助治疗(HAT)门诊。在 HAT 中,对美沙酮治疗耐药的阿片类药物依赖患者可以自行服用个体化滴定剂量的药物级二乙酰吗啡,同时口服美沙酮。
73 名可卡因依赖患者(90%为男性;平均年龄 48.7 岁),参加 HAT 治疗其美沙酮治疗耐药的共病阿片类药物依赖。
12 周的药物治疗,每天一次,监督摄入两片 SR-右旋苯丙胺(2×30mg/天)或两片相同的安慰剂片。
每 4 周评估一次:可卡因使用(时间线随访)、身体健康(Maudsley 成瘾概况-健康症状量表)、心理健康(简明症状量表)和非法活动(成瘾严重程度指数)。主要结局是“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域反应指数。
与安慰剂相比,SR-右旋苯丙胺在从基线前 4 周到治疗最后 4 周,可卡因无使用天数(P=0.004)和整体健康治疗反应者比例(P=0.045)均有较大增加。虽然在整个研究样本中,可卡因无使用天数与整体健康无关,但在 SR-右旋苯丙胺治疗开始时整体健康状况较差的患者(n=50)中,与整体健康呈正相关,即这些患者有潜力改善这个多域反应指数(比值比=1.076;95%置信区间=1.025-1.130)。
SR-右旋苯丙胺可减少可卡因的使用,并可能改善正在接受海洛因辅助治疗其共病海洛因依赖的可卡因依赖患者的临床相关健康相关结局。