EFFECTS OF BUSPIRONE IN WITHDRAWAL FROM OPIATES

描述（由申请人提供）：本项目的目标是评估 非阿片类药物丁螺环酮缓解 希望停止使用海洛因的海洛因成瘾者的戒断症状。那里 是丁螺环酮减弱戒断症状的临床前证据 是因为吗啡给药中断造成的在双盲试验中， 安慰剂对照的初步研究中，我们观察到丁螺环酮作为每日 30 mg的剂量比安慰剂更有效， 海洛因依赖者戒断过程中的主观症状 解毒 本研究拟随机抽取75名海洛因依赖者进行住院治疗 在两年的时间里，对5个群体进行解毒。审判将从一个 5-美沙酮稳定期。在最后2个稳定日， 美沙酮的剂量为30毫克。第一组将给予安慰剂，第二组给予安慰剂。 II美沙酮逐渐减量，III可乐定组和IV和V组 丁螺环酮（每日30 mg和45 mg）。在第14天，药物和安慰剂将被 停药，观察患者3天。试验将采用双盲。 戒断症状、心理变化、睡眠模式和海洛因渴求意愿 在整个试验过程中进行监测。 最常用于海洛因戒毒的药物是可乐定和 美沙酮有利亦有弊。可乐定不能抑制 所有戒断症状和美沙酮锥度只能用于许可的 诊所，可能很长时间。如果丁螺环酮能有效缓解海洛因 根据试点数据可以预期的戒断症状 在本申请中提出的，它可以用于缩短 海洛因成瘾者的住院或门诊戒毒。丁螺环酮具有 额外的优势。它没有镇静作用，没有戒断症状， 滥用潜力，不增强中枢神经系统抑制剂， 不会导致精神障碍

DESCRIPTION (provided by applicant): The goal of this project is to evaluate the efficacy of a non-opiate medication, buspirone, for the alleviation of withdrawal symptoms in heroin addicts who wish to discontinue heroin use. There is preclinical evidence that buspirone attenuates withdrawal symptomatology resulting from the interruption of morphine administration. In a double-blind, placebo controlled pilot study, we observed that buspirone given as a daily dose of 30 mg was more effective than placebo in alleviating objective and subjective withdrawal symptoms in heroin addicts in the course of detoxification. This project proposes to randomize 75 heroin addicts seeking inpatient detoxification to 5 groups over a 2-year period. The trial will start with a 5-day period of stabilization on methadone. On the last 2 stabilization days, the methadone dose will be 30 mg. Group I will then be given a placebo, group II methadone in tapering doses, group III clonidine and group IV and V buspirone (30 mg and 45 mg daily). On day 14, drugs and placebo will be discontinued and patients observed for 3 days. The trial will be double blind. Withdrawal signs, psychological changes, sleep patterns and heroin craving will be monitored throughout the trial. The agents most frequently used for heroin detoxification, clonidine and methadone have advantages as well as disadvantages. Clonidine does not suppress all withdrawal symptoms and a methadone taper can be used only in licensed clinics and can be lengthy. If buspirone proved effective in alleviating heroin withdrawal symptoms as could be anticipated in light of the pilot data presented in this application, it could be used to shorten the duration of the inpatient or outpatient detoxification of heroin addicts. Buspirone has additional advantages. It is not sedating, has no withdrawal symptoms, has no abuse potential, does not potentiate central nervous system depressants and does not induce psychomotor impairment.