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美沙酮辅助治疗阿片类药物使用障碍的临床效果:一项随机对照试验

Utility of a controlled amphetamine withdrawal paradigm among adults who use methamphetamine: A pilot clinical trial.

机构信息

Center for Health Services Research, Department of Psychiatry, College of Medicine, University of Arkansas for Medical Sciences, Little Rock, AR, USA.

College of Medicine, University of Arkansas for Medical Sciences, Little Rock, AR, USA.

出版信息

J Psychopharmacol. 2021 Nov;35(11):1420-1430. doi: 10.1177/02698811211050563. Epub 2021 Oct 26.

DOI:10.1177/02698811211050563
PMID:34697965
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10110391/
Abstract

BACKGROUND

The continued increase in prevalence of methamphetamine use in the United States has resulted in a significant increase in the number of patients entering treatment for methamphetamine use. However, no robustly efficacious pharmacologic treatment for methamphetamine use or withdrawal has been identified to date after stopping methamphetamine use.

AIMS

Given the association between methamphetamine withdrawal and relapse during early treatment, this study tested a controlled d-amphetamine withdrawal paradigm among methamphetamine-using individuals.

METHODS

Treatment-seeking adults who used methamphetamine ( = 34; 47% female; 100% white) were enrolled in a 4-week, randomized, double-blind, placebo-controlled trial in a residential setting, in which all participants were maintained on d-amphetamine (30 mg BID) during week 1, then half were switched to placebo during weeks 2-3. All participants received placebo during week 4. Outcomes included vital signs, withdrawal, cravings for methamphetamine, mood, and cognition. Bivariate analyses tested treatment group differences on baseline demographic and outcome variables. Repeated measures models examined main and interaction effects of treatment over time.

RESULTS/OUTCOMES: Participants were successfully randomized and safely stabilized on d-amphetamine. Craving for methamphetamine increased during weeks 2-3 in the placebo group relative to those on d-amphetamine. Interactions with age and heart rate were noted.

CONCLUSIONS/INTERPRETATION: To our knowledge, this is the first double-blind, placebo-controlled trial measuring pharmacologic effects of abruptly stopping controlled d-amphetamine administration in adults who use methamphetamine. Results support the potential of this withdrawal paradigm to further examine the efficacy of pharmacologic agents in ameliorating methamphetamine withdrawal symptoms.

摘要

背景

美国冰毒使用的流行率持续上升,导致接受冰毒使用治疗的患者人数显著增加。然而,在停止使用冰毒后,目前尚未确定任何针对冰毒使用或戒断的有效药物治疗方法。

目的

鉴于冰毒戒断与早期治疗期间复吸之间存在关联,本研究在使用冰毒的个体中测试了一种受控的安非他命戒断范式。

方法

在一个住宅环境中,招募了寻求治疗的使用冰毒的成年人( = 34;47%为女性;100%为白人),他们参加了一项为期 4 周、随机、双盲、安慰剂对照试验,在第 1 周所有参与者均接受安非他命(30 mg BID)治疗,然后一半参与者在第 2-3 周转为安慰剂治疗。所有参与者在第 4 周接受安慰剂治疗。结果包括生命体征、戒断症状、对冰毒的渴望、情绪和认知。双变量分析测试了治疗组在基线人口统计学和结果变量上的差异。重复测量模型检验了治疗随时间的主要和交互效应。

结果/结论:参与者被成功随机分组并安全地稳定在安非他命治疗上。与接受安非他命的参与者相比,安慰剂组在第 2-3 周时对冰毒的渴望增加。注意到与年龄和心率的相互作用。

解释

据我们所知,这是第一个测量骤停受控安非他命给药对使用冰毒的成年人药物影响的双盲、安慰剂对照试验。结果支持这种戒断范式在进一步研究药物治疗改善冰毒戒断症状的疗效方面具有潜力。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/13e1/10110391/3def7fb94aee/nihms-1881662-f0004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/13e1/10110391/de30f769eabf/nihms-1881662-f0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/13e1/10110391/d905bbee795c/nihms-1881662-f0002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/13e1/10110391/72e4eca4be71/nihms-1881662-f0003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/13e1/10110391/3def7fb94aee/nihms-1881662-f0004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/13e1/10110391/de30f769eabf/nihms-1881662-f0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/13e1/10110391/d905bbee795c/nihms-1881662-f0002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/13e1/10110391/72e4eca4be71/nihms-1881662-f0003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/13e1/10110391/3def7fb94aee/nihms-1881662-f0004.jpg

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