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一项双盲、随机、安慰剂对照、初步临床试验,旨在研究丁螺环酮作为辅助药物在美沙酮辅助监督下的阿片类药物戒断中的作用。

A double-blind, randomized, placebo-controlled, pilot clinical trial examining buspirone as an adjunctive medication during buprenorphine-assisted supervised opioid withdrawal.

机构信息

Behavioral Pharmacology Research Unit, Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine.

出版信息

Exp Clin Psychopharmacol. 2023 Feb;31(1):194-203. doi: 10.1037/pha0000550. Epub 2022 Mar 10.

DOI:10.1037/pha0000550
PMID:35266779
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11000212/
Abstract

Successful management of opioid withdrawal improves long-term treatment outcomes and reduces opioid use-related morbidity and mortality. Mechanistically supported pharmacotherapeutic approaches are needed to effectively manage acute and protracted opioid withdrawal. Buspirone is a D2 antagonist and 5-HT1a agonist that may decrease opioid withdrawal. Individuals ( = 15) admitted to a residential treatment center for opioid use disorder (OUD) were enrolled into a double-blind randomized clinical trial to assess the efficacy and acceptability of buspirone (45 mg/day) as an adjunctive medication to buprenorphine-assisted, supervised opioid withdrawal. Participants completed daily questionnaires which consisted of the Subjective Opiate Withdrawal Scale (SOWS) and a consensus sleep diary, which assessed total sleep time, time to sleep onset, and sleep quality. Total SOWS scores, individual opioid withdrawal symptoms and sleep outcomes were assessed between treatment groups (Placebo and Buspirone) and over time in a repeated measures linear mixed model. Total SOWS scores significantly decreased across study phases for both groups but decreased to a greater extent among individuals assigned to buspirone during both the first and second week of stable buspirone. Greater decreases in withdrawal were observed during Week 2 of stable buspirone relative to Week 1 of stable buspirone. Participants also reported significant increases in sleep duration and significant decreases in latency to sleep onset. This study provides further support that buspirone can help mitigate opioid withdrawal during a supervised opioid taper. Buspirone may confer unique benefits during protracted withdrawal periods. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

摘要

成功管理阿片类药物戒断可改善长期治疗结局,并降低阿片类药物使用相关的发病率和死亡率。需要机制上支持的药物治疗方法来有效管理急性和慢性阿片类药物戒断。丁螺环酮是一种 D2 拮抗剂和 5-HT1a 激动剂,可能会减少阿片类药物戒断。将 15 名因阿片类药物使用障碍(OUD)而住院治疗的个体纳入一项双盲随机临床试验,以评估丁螺环酮(45mg/天)作为辅助药物与丁丙诺啡辅助、监督阿片类药物戒断的疗效和可接受性。参与者每天完成问卷,其中包括主观阿片戒断量表(SOWS)和共识睡眠日记,评估总睡眠时间、入睡时间和睡眠质量。在重复测量线性混合模型中,根据治疗组(安慰剂和丁螺环酮)和时间评估总 SOWS 评分、个体阿片戒断症状和睡眠结果。两组的总 SOWS 评分在研究各阶段均显著降低,但在稳定丁螺环酮治疗的第一和第二周内,接受丁螺环酮的个体降低幅度更大。与稳定丁螺环酮治疗的第 1 周相比,在稳定丁螺环酮治疗的第 2 周,戒断反应的降幅更大。参与者还报告说,睡眠时间显著增加,入睡潜伏期显著缩短。这项研究进一步支持了丁螺环酮可以帮助减轻监督下阿片类药物减量过程中的阿片类药物戒断。丁螺环酮在长期戒断期间可能具有独特的益处。(PsycInfo 数据库记录(c)2023 APA,保留所有权利)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/69a8/11000212/5f00498a6e82/nihms-1874889-f0002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/69a8/11000212/872ec6080830/nihms-1874889-f0003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/69a8/11000212/661e7bb94eab/nihms-1874889-f0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/69a8/11000212/5f00498a6e82/nihms-1874889-f0002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/69a8/11000212/872ec6080830/nihms-1874889-f0003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/69a8/11000212/661e7bb94eab/nihms-1874889-f0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/69a8/11000212/5f00498a6e82/nihms-1874889-f0002.jpg

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