Ciraulo Domenic A, Sarid-Segal Ofra, Knapp Clifford M, Ciraulo Ann Marie, LoCastro Joseph, Bloch Daniel A, Montgomery Margaret A, Leiderman Deborah B, Elkashef Ahmed
Division of Psychiatry, Boston University School of Medicine, VA Boston Healthcare System Medication Development Research Unit (MDRU), Boston, MA, USA.
Addiction. 2005 Mar;100 Suppl 1:12-22. doi: 10.1111/j.1360-0443.2005.00985.x.
The two studies presented here were conducted to assess the efficacy of paroxetine, pentoxifylline, riluzole, venlafaxine and pramipexole as medications for the treatment of cocaine dependence.
A multi-arm, modified blinded, placebo-controlled design was used.
The studies were conducted at the Boston VA Healthcare System and the Boston University School of Medicine Medication Development Research Unit (MDRU).
Participants met criteria for cocaine dependence during a 2-week screening period.
Following random assignment to one of the treatment groups, subjects received active medication or placebo for 8 weeks in combination with cognitive behavioral counseling. In the first study the efficacy of the antidepressant paroxetine (20 mg daily), the phosphodiesterase inhibitor pentoxifylline (1200 mg daily) and the glutamate release inhibitor riluzole (100 mg daily) was assessed. The antidepressant venlafaxine (150 mg daily) and the dopamine agonist pramipexole (1.5 mg daily) were evaluated in the second study.
Urine benzoylecgonine (BE) concentrations, self-report of cocaine use and global impression scores served as primary outcome measures. Secondary measures included assessments of cocaine craving and psychiatric functioning. Adverse events were monitored during the treatment period.
None of the active medications produced greater reductions in urine BE concentrations over the treatment period than did placebo. There were trends for BE levels to become reduced in the pentoxifylline group during the first 4 weeks of treatment and for Addiction Severity Index (ASI) drug composite scores to be lower in the pentoxyfylline group at end-point compared to the placebo group. Significant within-group reductions in reported cocaine use and craving were found for all treatment groups, but none of the active medications were superior to placebo on these measures. The accuracy of self-reported cocaine use declined over the study period. Overall, the active medications were well tolerated.
This study does not support the use of paroxetine, pentoxifylline, riluzole, venlafaxine or pramipexole for the treatment of cocaine dependence. However, these results need to be interpreted with caution because of the small size and lack of homogeneity of the experimental groups.
开展此处介绍的两项研究，以评估帕罗西汀、己酮可可碱、利鲁唑、文拉法辛和普拉克索作为治疗可卡因依赖药物的疗效。
采用多组、改良盲法、安慰剂对照设计。
研究在波士顿退伍军人事务部医疗保健系统和波士顿大学医学院药物研发研究单位（MDRU）进行。
参与者在为期2周的筛查期内符合可卡因依赖标准。
随机分配至其中一个治疗组后，受试者接受8周的活性药物或安慰剂治疗，并结合认知行为咨询。在第一项研究中，评估了抗抑郁药帕罗西汀（每日20毫克）、磷酸二酯酶抑制剂己酮可可碱（每日1200毫克）和谷氨酸释放抑制剂利鲁唑（每日100毫克）的疗效。在第二项研究中，评估了抗抑郁药文拉法辛（每日150毫克）和多巴胺激动剂普拉克索（每日1.5毫克）。
尿中苯甲酰爱康宁（BE）浓度、可卡因使用的自我报告和整体印象评分作为主要结局指标。次要指标包括对可卡因渴望和精神功能的评估。在治疗期间监测不良事件。
在治疗期间，没有一种活性药物比安慰剂使尿中BE浓度降低得更多。己酮可可碱组在治疗的前4周有BE水平降低的趋势，且与安慰剂组相比，己酮可可碱组在终点时的成瘾严重程度指数（ASI）药物综合评分更低。所有治疗组在报告的可卡因使用和渴望方面均有显著的组内降低，但在这些指标上，没有一种活性药物优于安慰剂。在研究期间，自我报告的可卡因使用的准确性下降。总体而言，活性药物耐受性良好。
本研究不支持使用帕罗西汀、己酮可可碱、利鲁唑、文拉法辛或普拉克索治疗可卡因依赖。然而，由于实验组规模小且缺乏同质性，这些结果需要谨慎解释。
