EFFECTS OF BUSPIRONE IN WITHDRAWAL FROM OPIATES

描述(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高血压的疗效 希望停止使用海洛因的海洛因成瘾者的戒断症状。那里 丁螺环酮缓解戒断症状的临床前证据 是由于吗啡给药中断造成的。在双盲的情况下， 安慰剂对照试验研究，我们观察到丁螺环酮作为每日给药 30毫克剂量比安慰剂更有效地缓解客观和 海洛因依赖者在戒毒过程中的主观戒断症状 解毒。 该项目建议将75名寻求住院的海洛因成瘾者随机分组 在两年的时间里分成5组戒毒。审判将以一项 美沙酮5天稳定期。在过去的两个稳定日里， 美沙酮的剂量是30毫克。然后给I组服用安慰剂， II美沙酮递减剂量，III组可乐定以及IV和V组 丁螺环酮(每天30毫克和45毫克)。在第14天，药物和安慰剂将 停药，患者观察3天。这项试验将是双盲的。 戒断症状、心理变化、睡眠模式和海洛因渴求意愿 在整个试验过程中都受到监控。 最常用于海洛因戒毒的药物可乐定和 美沙酮既有优点也有缺点。可乐定不抑制 所有戒断症状和美沙酮减量药只能在有执照的 诊所，可能会很长。如果丁螺环酮被证明能有效缓解海洛因 根据试点数据可以预料到的戒断症状 在此应用程序中提供的，它可以用来缩短 海洛因成瘾者住院或门诊戒毒。丁螺环酮有 其他优势。它没有镇静剂，没有戒断症状，没有 滥用潜力，不会增强中枢神经系统镇静剂和 不会导致精神运动障碍。

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.