Sofuoglu Mehmet, Poling James, Babuscio Theresa, Gonsai Kishorchandra, Severino Kevin, Nich Charla, Carroll Kathleen M
VA Connecticut Healthcare System, West Haven, CT, United States; Yale University, School of Medicine, Department of Psychiatry, New Haven, CT, United States.
VA Connecticut Healthcare System, West Haven, CT, United States; Yale University, School of Medicine, Department of Psychiatry, New Haven, CT, United States.
J Subst Abuse Treat. 2017 Feb;73:63-69. doi: 10.1016/j.jsat.2016.11.005. Epub 2016 Nov 17.
The goal of this study was too test the efficacy of carvedilol (CAR), an adrenergic blocker, for reducing cocaine use in individuals with cocaine use disorder (CUD). We conducted a 17-week, double-blind, randomized controlled trial with 3 treatment arms: 25mg CAR, 50mg CAR, and placebo.
One hundred and six treatment-seeking opioid and cocaine-dependent participants, who were also maintained on methadone during study participation, were randomized to placebo (n=34), 25mg/day CAR (n=37) or 50mg/day CAR (n=35). The main outcome measures were cocaine and opioid use as assessed by urine drug screening and self-reported drug use.
No significant group differences were found for treatment retention with 56% of the placebo, 76% of the 25mg and 66% of the 50mg CAR groups (p>0.05) completing treatment. The percentage (SD) of cocaine positive urines during the trial showed an overall treatment effect: 59.2 (38.9) for the placebo, 50.8 (33.8) for the 25mg and 75.1 (33.2) for the 50mg CAR group. In post hoc comparisons, neither the 25 nor 50mg CAR condition differed significantly from the placebo; however, the 25mg CAR group had a significantly lower proportion of cocaine-positive urines than the 50mg group. No significant group differences were found for the percentage of self-reported days of cocaine abstinence during the trial: 72.9 (25.3) for placebo, 72.9 (29) for CAR 25mg, and 59.3 (31.7) for CAR 50mg. Significant groups differences in the proportion of opioid positive urines submitted were not observed (p>0.05). Baseline cocaine withdrawal severity did not predict treatment response (p>0.05).
These findings did not support the efficacy of CAR for the treatment of cocaine use in cocaine and opioid dependent participants maintained on methadone. Further, CAR doses >25mg should not be used to avoid possible increases in cocaine and opioid use.
本研究的目的是测试肾上腺素能阻滞剂卡维地洛（CAR）在减少可卡因使用障碍（CUD）个体的可卡因使用方面的疗效。我们进行了一项为期17周的双盲随机对照试验，设有3个治疗组：25mg卡维地洛组、50mg卡维地洛组和安慰剂组。
106名寻求治疗的阿片类药物和可卡因依赖参与者，在研究期间同时维持美沙酮治疗，被随机分为安慰剂组（n = 34）、25mg/天卡维地洛组（n = 37）或50mg/天卡维地洛组（n = 35）。主要结局指标是通过尿液药物筛查和自我报告的药物使用情况评估的可卡因和阿片类药物使用。
治疗保留率方面未发现显著的组间差异，安慰剂组56%、25mg卡维地洛组76%、50mg卡维地洛组66%完成了治疗（p>0.05）。试验期间可卡因阳性尿液的百分比（标准差）显示出总体治疗效果：安慰剂组为59.2（38.9），25mg卡维地洛组为50.8（33.8），50mg卡维地洛组为75.1（33.2）。在事后比较中，25mg和50mg卡维地洛组与安慰剂组均无显著差异；然而，25mg卡维地洛组可卡因阳性尿液的比例显著低于50mg组。试验期间自我报告的可卡因戒断天数百分比在组间未发现显著差异：安慰剂组为72.9（25.3），25mg卡维地洛组为72.9（29），50mg卡维地洛组为59.3（31.7）。在提交的阿片类药物阳性尿液比例方面未观察到显著的组间差异（p>0.05）。基线可卡因戒断严重程度不能预测治疗反应（p>0.05）。
这些发现不支持卡维地洛对维持美沙酮治疗的可卡因和阿片类药物依赖参与者的可卡因使用治疗有效。此外，不应使用超过25mg的卡维地洛剂量，以避免可卡因和阿片类药物使用可能增加。
