一项关于利血平治疗可卡因依赖的双盲、安慰剂对照试验。
A double-blind, placebo-controlled trial of reserpine for the treatment of cocaine dependence.
作者信息
Winhusen Theresa, Somoza Eugene, Sarid-Segal Ofra, Goldsmith R Jeffrey, Harrer Judy M, Coleman Florence S, Kahn Roberta, Osman Sabuhi, Mezinskis Juris, Li Shou-Hua, Lewis Daniel, Afshar Maryam, Ciraulo Domenic A, Horn Paul, Montgomery Margaret A, Elkashef Ahmed
机构信息
Department of Psychiatry, University of Cincinnati College of Medicine, 231 Albert Sabin Way, Cincinnati, OH 45267, USA.
出版信息
Drug Alcohol Depend. 2007 Dec 1;91(2-3):205-12. doi: 10.1016/j.drugalcdep.2007.05.021. Epub 2007 Jul 12.
BACKGROUND
Cocaine's increase of dopamine is strongly associated with its reinforcing properties and, thus, agents that reduce dopamine have received much attention as candidate cocaine-dependence treatments. The potential efficacy of reserpine, a dopamine depletor, for treating cocaine dependence is suggested by both pre-clinical research and a small clinical trial.
METHOD
One hundred and nineteen participants who met DSM-IV criteria for cocaine dependence were enrolled into this 12-week, double-blind, placebo-controlled outpatient trial. Participants received either reserpine (0.5 mg/day) or matching placebo. All participants received 1h of manualized individual cognitive behavioral therapy on a weekly basis. Outcome measures included cocaine use as determined by self-report confirmed with urine benzoylecgonine results, cocaine craving, addiction severity index scores, and clinical global impression scores. Safety measures included adverse events, EKGs, vital signs, laboratory tests, and the Hamilton Depression Inventory.
RESULTS
Seventy-nine participants (i.e., 66%) completed the 12-week trial. The safety results suggest that reserpine was safe and well tolerated by the participants. The efficacy measures indicated no significant differences between reserpine and placebo.
CONCLUSION
These results do not support the efficacy of reserpine as a cocaine-dependence treatment.
背景
可卡因对多巴胺的增加与其强化特性密切相关，因此，作为可卡因依赖治疗候选药物，能减少多巴胺的药物备受关注。临床前研究和一项小型临床试验均表明，多巴胺耗竭剂利血平治疗可卡因依赖具有潜在疗效。
方法
119名符合《精神疾病诊断与统计手册》第四版（DSM-IV）可卡因依赖标准的参与者被纳入这项为期12周的双盲、安慰剂对照门诊试验。参与者分别接受利血平（0.5毫克/天）或匹配的安慰剂治疗。所有参与者每周接受1小时的标准化个体认知行为疗法。结果指标包括通过自我报告并经尿中苯甲酰爱康宁结果确认的可卡因使用情况、对可卡因的渴望程度、成瘾严重程度指数得分以及临床总体印象评分。安全指标包括不良事件、心电图、生命体征、实验室检查以及汉密尔顿抑郁量表。
结果
79名参与者（即66%）完成了为期12周的试验。安全性结果表明，参与者对利血平耐受性良好且安全。疗效指标显示，利血平与安慰剂之间无显著差异。
结论
这些结果不支持利血平作为可卡因依赖治疗药物的疗效。
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