EFFECTS OF BUSPIRONE IN WITHDRAWAL FROM OPIATES

丁螺环酮对戒除阿片类药物的影响

• 批准号: 6430318
• 负责人: LAURE B BUYDENS-BRANCHEY
• 金额: $ 15.6万
• 依托单位: NARROWS INSTITUTE FOR BIOMEDICAL RES INC
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-09-27 至 2003-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6430318
• 关键词: behavioral /social science research tag; buspirone; clinical trial phase I; clonidine; craving; detoxification; drug abuse chemotherapy; drug addiction; drug administration rate /duration; drug metabolism; drug withdrawal; heroin; human subject; human therapy evaluation; interview; longitudinal human study; methadone; opiate alkaloid; patient oriented research; questionnaires; therapy compliance; urinalysis

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.

描述（由申请人提供）：该项目的目标是评估 非阿片类药物丁螺环酮对于缓解疼痛的功效 希望停止使用海洛因的海洛因成瘾者出现戒断症状。那里 是丁螺环酮减轻戒断症状的临床前证据 吗啡给药中断所致。在双盲的情况下， 在安慰剂对照试点研究中，我们观察到丁螺环酮每天服用 30 mg 的剂量比安慰剂更能有效地缓解客观和 海洛因成瘾者主观戒断症状 排毒。 该项目提议对 75 名寻求住院治疗的海洛因成瘾者进行随机分组 在2年的时间内对5组进行戒毒。审判将从 美沙酮 5 天稳定期。在过去 2 个稳定日里， 美沙酮剂量为 30 毫克。然后给第一组服用安慰剂， II 美沙酮逐渐减少剂量，第 III 组可乐定以及第 IV 和 V 组 丁螺环酮（每日 30 毫克和 45 毫克）。第 14 天，将服用药物和安慰剂 停药并观察患者3天。审判将是双盲的。 戒断症状、心理变化、睡眠模式和对海洛因的渴望都会 在整个试验过程中受到监控。 最常用于海洛因解毒的药物是可乐定和 美沙酮有优点也有缺点。可乐定不抑制 所有戒断症状和美沙酮逐渐减量只能在获得许可的情况下使用 诊所，并且可能会很长。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见戒断症状 在本申请中提出，它可用于缩短 海洛因成瘾者住院或门诊戒毒。丁螺环酮有 额外的优势。它没有镇静作用，没有戒断症状，​​没有 滥用潜力，不会增强中枢神经系统抑制剂的作用， 不会引起精神运动障碍。