Division on Substance Use Disorders, New York State Psychiatric Institute, New York, NY, USA.
Department of Psychiatry, Columbia University Irving Medical Center, New York, NY, USA.
Am J Drug Alcohol Abuse. 2021 May 4;47(3):402-409. doi: 10.1080/00952990.2021.1885677. Epub 2021 Apr 2.
: Cocaine use disorder (CUD) is a substantial public health problem with no FDA-approved medication treatments. Psychostimulants have shown promise as pharmacotherapy for CUD. Lisdexamfetamine, a novel prodrug psychostimulant, is roughly 40-50% as potent as dextroamphetamine.: To evaluate the safety, tolerability, and optimal dosing of lisdexamfetamine for treating CUD.: Open-label, 8-week trial of 17 CUD adults. Participants were titrated to the maximum tolerated dose of 140 mg over 2-week period and maintained for 4 weeks, followed by a two-week taper period. The primary outcome measures were the maximum daily dose achieved during the study period and tolerability as measured by medication-related study drop-out.: Among the 16 participants with post-enrollment data, the mean dose of lisdexamfetamine achieved was 118.1 mg (standard deviation (SD) = 40.4), mean retention was 6.5 weeks (SD = 2.0), and no participants discontinued study medication due to adverse effects. Four participants had dose reductions due to adverse effects and continued in the trial. Six participants (37.5%) were abstinent for the last 3 weeks of their study participation. Mean dollars of cocaine spent per day significantly decreased from $19.72 at baseline to $7.57 during the last 3 weeks of study participation ( = 3.60, = .003). The mean percent of using days significantly decreased from 25% at baseline to 12% during the last 3 weeks of study participation ( = 3.33, = .005).: The use of lisdexamfetamine for CUD in doses ranging to 140 mg daily was safe and generally well tolerated.
可卡因使用障碍（CUD）是一个严重的公共卫生问题，目前尚无获得 FDA 批准的药物治疗方法。 苯丙胺类兴奋剂已显示出作为 CUD 药物治疗的潜力。 利右苯丙胺是一种新型前药苯丙胺类兴奋剂，其效力大约是右旋苯丙胺的 40-50%。 评估利右苯丙胺治疗 CUD 的安全性、耐受性和最佳剂量。 一项 17 例 CUD 成年患者的开放标签、8 周试验。 参与者在 2 周内滴定至最大耐受剂量 140mg，并维持 4 周，随后进行为期 2 周的减量期。 主要结局指标是研究期间达到的最大日剂量和耐受性，以药物相关的研究脱落来衡量。 在有入组后数据的 16 名参与者中，利右苯丙胺的平均剂量为 118.1mg（标准差[SD] = 40.4），平均保留时间为 6.5 周（SD = 2.0），没有参与者因不良反应而停止研究药物。 由于不良反应，有 4 名参与者减少剂量，但继续参与试验。 6 名参与者（37.5%）在研究参与的最后 3 周内保持禁欲。 从基线时的每天 19.72 美元降至研究参与的最后 3 周时的每天 7.57 美元（t = 3.60，P =.003），可卡因日均消费金额显著降低。 从基线时的 25%降至研究参与的最后 3 周时的 12%（t = 3.33，P =.005），使用天数的百分比显著降低。 在 140mg 每日剂量范围内，利右苯丙胺治疗 CUD 的安全性和耐受性良好。
