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单次剂量丁丙诺啡对减少阿片类药物渴望和自杀意念的快速作用:一项随机、双盲、安慰剂对照研究。

Rapid effect of a single-dose buprenorphine on reduction of opioid craving and suicidal ideation: A randomized, double blind, placebo-controlled study.

作者信息

Ahmadi Jamshid, Sarani Ebrahim Moghimi, Jahromi Mina Sefidfard

机构信息

Substance Abuse Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.

出版信息

Tzu Chi Med J. 2019 Mar 14;32(1):58-64. doi: 10.4103/tcmj.tcmj_220_18. eCollection 2020 Jan-Mar.

Abstract

OBJECTIVE

Opioid use disorder is a prevalent addiction problem that can be treated with buprenorphine, but dependence, diversion, and abuse of buprenorphine occur. Although including naloxone reduces these problems, the combination formulation is not available worldwide. The administration of the medication under supervision may also be useful in decreasing unintended uses of the medication. The objective is to assess the influence of a single, physician-administered dose of buprenorphine on withdrawal craving and suicidal ideation in opioid-dependent patients over a period of 4 days of abstinence from opioids.

MATERIALS AND METHODS

Sixty-one men who used heroin, opium, or prescription opioids and met Diagnostic and Statistical Manual of Mental Disorders Five Edition criteria for opioid use disorder were randomized to receive a single, sublingual dose of buprenorphine (16 mg, 32 mg, or placebo; n's = 20, 20, and 21 per group). The study was carried out in an inpatient psychiatric ward, with appropriate precautions and monitoring of cardiovascular and respiratory measures. Buprenorphine was administered when the patients were in moderate opioid withdrawal, exhibiting four to five symptoms. Self-reports of craving (The Opioid Craving Scale) and suicidal ideation (Beck Scale for Suicidal Ideation) were taken at baseline and on each of the 4 days after treatment.

RESULTS

The group did not differ significantly on demographic features, and all of the patients completed the 4-day study. Craving was reduced from baseline during the observation period in each of the three groups, demonstrating a significant effect of treatment ( < 0.0005), and the dose-by-time interaction ( < 0.0005). Both 32 mg and 16 mg groups differed significantly from the placebo group. No significant differences were observed between the 32 and 16 mg groups, suggesting that the maximal effect on craving reduction was achieved with the 16-mg dose. Suicidal ideation was decreased from baseline during the observation period in each of the three groups, demonstrating a significant effect of treatment ( < 0.0005), and the dose-by-time interaction ( < 0.017).The 32 mg group differed significantly from the placebo group. No significant differences were observed between the 16 and placebo groups, suggesting that the maximal effect on suicidal ideation reduction was achieved with the 32 mg dose.

CONCLUSIONS

A single high dose of 16 mg or 32 mg buprenorphine reduces opioid craving, but a single high dose of only 32 mg buprenorphine reduces suicidal ideation.

摘要

目的

阿片类药物使用障碍是一个普遍存在的成瘾问题,可用丁丙诺啡治疗,但丁丙诺啡存在依赖、转移和滥用的情况。尽管加入纳洛酮可减少这些问题,但这种复方制剂在全球并非都有。在监督下给药可能也有助于减少药物的意外使用。目的是评估在阿片类药物依赖患者停用阿片类药物4天期间,单次由医生给予的丁丙诺啡剂量对戒断渴求及自杀观念的影响。

材料与方法

61名使用海洛因、鸦片或处方阿片类药物且符合《精神疾病诊断与统计手册》第五版阿片类药物使用障碍标准的男性被随机分组,分别接受单次舌下含服丁丙诺啡(16毫克、32毫克或安慰剂;每组n分别为20、20和21)。该研究在一家住院精神科病房进行,采取了适当的预防措施并监测心血管和呼吸指标。当患者处于中度阿片类药物戒断状态、出现四到五种症状时给予丁丙诺啡。在基线期以及治疗后的4天每天采集渴求(阿片类药物渴求量表)和自杀观念(贝克自杀观念量表)的自我报告。

结果

各组在人口统计学特征方面无显著差异,所有患者均完成了为期4天的研究。在观察期内,三组中每组的渴求程度均较基线期降低,显示出治疗的显著效果(<0.0005)以及剂量 - 时间交互作用(<0.0005)。32毫克组和16毫克组与安慰剂组均有显著差异。32毫克组和16毫克组之间未观察到显著差异,表明16毫克剂量已达到减少渴求的最大效果。在观察期内,三组中每组的自杀观念均较基线期减少,显示出治疗的显著效果(<0.0005)以及剂量 - 时间交互作用(<0.017)。32毫克组与安慰剂组有显著差异。16毫克组和安慰剂组之间未观察到显著差异,表明32毫克剂量已达到减少自杀观念的最大效果。

结论

单次高剂量的16毫克或32毫克丁丙诺啡可减少阿片类药物渴求,但仅单次高剂量的32毫克丁丙诺啡可减少自杀观念。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/deed/7015018/33effa217ce0/TCMJ-32-58-g001.jpg

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