A medication screening trial evaluation of reserpine, gabapentin and lamotrigine pharmacotherapy of cocaine dependence
A medication screening trial evaluation of reserpine, gabapentin and lamotrigine pharmacotherapy of cocaine dependence
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DOI：
10.1111/j.1360-0443.2005.00983.x
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发表时间：
2005-03-01
期刊：
影响因子：
6
通讯作者：
Elkashef, A
中科院分区：
文献类型：
--
作者：
Berger, SP;Winhusen, TM;Elkashef, A
目的：初步评价利血平、加巴喷丁或拉莫三嗪与作为可卡因依赖治疗的不匹配的安慰剂对照。设计一项10周的门诊患者研究，使用可卡因快速有效性和安全性试验（CREST）研究设计。设置该研究在辛辛那提药物开发研究单位（MDRU）进行。参与者符合诊断和统计手册第IV版（DSM-IV）可卡因依赖标准。60名参与者被招募，50名参与者完成最终的研究measures.Intervention药物的目标每日剂量为利血平0.5毫克，加巴喷丁1800毫克和拉莫三嗪150毫克。所有参与者每周接受1小时的手动个体认知行为治疗，主要疗效指标包括尿苯甲酰爱子碱（BE）水平、可卡因临床总体印象量表观察者和可卡因使用的自我报告。安全措施包括不良事件，心电图（ECG），生命体征和实验室tests.Findings可卡因依赖的主观措施表明所有研究组的显着改善。尿BE结果表明利血平组有显著改善（P < 0.05），其他研究组无显著变化。未发现可归因于任何药物治疗的体格检查或实验室检查异常模式。报告了3起严重不良事件，均与研究程序无关。结论利血平可能是一种值得进一步研究的可卡因依赖治疗药物。
Aims To conduct a preliminary evaluation of the safety and efficacy of reserpine, gabapentin or lamotrigine versus an,unmatched placebo control as a treatment for cocaine dependence.Design A 10-week out-patient study using the Cocaine Rapid Efficacy and Safety Trial (CREST) study design.Setting The study was conducted at the Cincinnati Medication Development Research Unit (MDRU).Participants Participants met Diagnostic and Statistical Manual version IV (DSM-IV) criteria for cocaine dependence. Sixty participants were enrolled, with 50 participants completing the final study measures.Intervention The targeted daily doses of medication were reserpine 0.5 mg, gabapentin 1800 mg and lamotrigine 150 mg. All participants received I hour of manualized individual cognitive behavioral therapy on a weekly basis.Measurements Primary outcome measures of efficacy included urine benzoylecgonine (BE) level, Cocaine Clinical Global Impression scale-observer and self-report of cocaine use. Safety measures included adverse events, electrocardiograms (ECGs), vital signs and laboratory tests.Findings Subjective measures of cocaine dependence indicated significant improvement for all study groups. Urine BE results indicated a significant improvement for the reserpine group (P < 0.05) and non-significant changes for the other study groups. No pattern of physical or laboratory abnormalities attributable to treatment with any of the medications was identified. There were three serious adverse events reported, none of which were related to study procedures. The medications appeared to be tolerated well.Conclusions The present findings suggest that reserpine maybe worthy of further study as a cocaine dependence treatment.