Amphetamine-Related Disorders

苯丙胺相关疾病
  • 文章类型: Journal Article
    背景:在美国,与甲基苯丙胺相关的过量死亡和药物治疗入院人数正在上升。这项研究旨在测量和比较美国与甲基苯丙胺有关的精神病住院的时间趋势。
    方法:我们以人群为基础,美国精神病住院率的趋势分析,并计算出每100,000名涉及物质的精神病住院患者的季度(Q)率.我们使用Joinpoint回归评估了美国地区季度住院率百分比变化。
    结果:从2015年第四季度到2019年第四季度,有963,202例精神病住院,50,223(5.2%)涉及甲基苯丙胺,102,877(10.7%)涉及阿片类药物和/或可卡因,不含甲基苯丙胺。涉及甲基苯丙胺的精神病住院率增加了68.0%,涉及阿片类药物和/或可卡因而不含甲基苯丙胺的精神病住院率下降了22%,而非物质相关的精神病住院率保持不变。与甲基苯丙胺有关的精神病住院率的最大显着增加是在61岁以上的人群中,男性,和中西部人。在黑人患者中,涉及甲基苯丙胺的精神病住院率翻了一番。在中西部地区,与甲基苯丙胺有关的精神病住院治疗的平均增幅最大,为2015年第四季度至2017年第二季度的10.2%。
    结论:大多数精神病住院不涉及药物。涉及甲基苯丙胺的精神病住院治疗大大增加,而涉及阿片类药物的精神病住院治疗减少,但涉及更多的接触。获得更多减少伤害服务的机会,应急管理计划,迫切需要精神卫生服务。
    BACKGROUND: In the U.S., overdose deaths and substance treatment admissions related to methamphetamine are rising. This study aims to measure and compare U.S. temporal trends in methamphetamine-involved psychiatric hospitalizations.
    METHODS: We conducted a population-based, trend analysis of U.S. psychiatric hospitalizations and calculated quarterly (Q) rates per 100,000 population of substance-involved psychiatric hospitalizations. We assessed U.S. regional quarterly percentage hospitalization rate changes using Joinpoint regression.
    RESULTS: From Q4 2015-Q4 2019, there were 963,202 psychiatric hospitalizations, 50,223 (5.2 %) involved methamphetamine and 102,877 (10.7 %) involved opioids and/or cocaine without methamphetamine. Methamphetamine-involved psychiatric hospitalization rates increased by 68.0 %, psychiatric hospitalizations rates involving opioid and/or cocaine without methamphetamine decreased by 22 %, while nonsubstance-involved psychiatric hospitalizations rates remained unchanged. The largest significant increases in methamphetamine-involved psychiatric hospitalization rates were among people >61 years old, males, and Midwesterners. Methamphetamine-involved psychiatric hospitalization rates doubled among Black patients. The largest average percent increase among methamphetamine-involved psychiatric hospitalizations was 10.2 % from Q4 2015-Q2 2017 in the Midwest.
    CONCLUSIONS: Most psychiatric hospitalizations did not involve substances. Methamphetamine-involved psychiatric hospitalizations greatly increased while opioid-involved psychiatric hospitalizations decreased, but involved more total encounters. Greater access to harm reduction services, contingency management programs, and mental health services is urgently needed.
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  • 文章类型: Journal Article
    背景:甲基苯丙胺和其他兴奋剂的治疗可能是有效的,但治疗消耗和持续使用非常高。禁欲是用于评估治疗成功的常规结果,但是以这种方式定义治疗成功错过了促进改善健康的机会,即使没有实现禁欲。在不禁欲的情况下减少甲基苯丙胺和兴奋剂的使用与许多积极结果有关。然而,对治疗期间的药物使用模式或长期使用趋势知之甚少。
    方法:我们使用治疗事件数据集-放电(TEDS-D)来识别具有指定为主要使用物质的兴奋剂药物的治疗事件(2017-2021;N=251,841;甲基苯丙胺,可卡因,其他安非他明,或其他兴奋剂)。我们的结果是入院和出院之间药物使用频率的变化(禁欲减少使用,减少使用而不禁欲,增加使用)。我们使用多元逻辑回归对药物使用频率的变化进行建模,按年份预测,兴奋剂类型,和他们的互动。
    结果:近三分之二的样本(60%)将甲基苯丙胺指定为主要使用兴奋剂。随着时间的推移,预测的禁欲率有所下降,在使用甲基苯丙胺的人群中,恶化趋势最强。入院和出院时的每日和定期药物使用(使用没有变化)随着时间的推移变得更糟,特别是那些使用甲基苯丙胺的人。
    结论:治疗结果随着时间的推移恶化,在那些报告甲基苯丙胺的患者中下降最快。禁欲很少见,大多数治疗客户都没有改变他们的吸毒行为。我们建议在国家的治疗系统继续努力应对兴奋剂危机的同时,重新关注基于证据的伤害减少。
    BACKGROUND: Treatment for methamphetamine and other stimulants can be effective but treatment attrition and continued use are very high. Abstinence is the conventional outcome used to evaluate treatment success, but defining treatment success in this way misses opportunities to promote improved health even when abstinence is not achieved. Reducing methamphetamine and stimulant use without abstinence is associated with many positive outcomes. However, little is known about drug use patterns during treatment or trends in use over time.
    METHODS: We used the Treatment Episode Dataset-Discharges (TEDS-D) to identify treatment episodes that had a stimulant drug indicated as the primary substance of use (2017-2021; N=251,841; methamphetamine, cocaine, other amphetamines, or other stimulants). Our outcome was the change in the frequency of drug use between admission and discharge (decreased use with abstinence, decreased use without abstinence, increased use). We used multiple logistic regression to model a change in drug use frequency, predicted by year, stimulant type, and their interaction.
    RESULTS: Nearly two-thirds of the sample (60 %) had methamphetamine indicated as the primary stimulant of use. There was a decrease in the predicted rate of abstinence over time and worsening trends were strongest among those using methamphetamine. Daily and periodic drug use at both admission and discharge (no change in use) became worse over time, particularly for those using methamphetamine.
    CONCLUSIONS: Treatment outcomes worsened over time and declined fastest among those reporting methamphetamine. Abstinence was rare and most treatment clients did not change their drug use behavior. We recommend a renewed focus on evidence-based harm reduction while the nation\'s treatment systems continue grappling with the stimulant crises.
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  • 文章类型: Case Reports
    我们介绍了一名14岁的患者,他因意外服用芬太尼过量而住院后在我们的初级保健诊所建立了护理。他们被诊断为严重的阿片类药物使用障碍(OUD)和兴奋剂使用障碍(StUD),并在住院期间开始丁丙诺啡。然后,他们被转移到她所在县唯一已知的门诊初级保健诊所,该诊所正在积极为青少年阿片类药物使用障碍(MOUD)提供药物。在第一次访问时,他们报告了20次用药过量的历史,努力坚持丁丙诺啡和持续的阿片类药物渴望。与他们和他们的父母一起审查了过量安全计划,包括向他们提供纳洛酮试剂盒,芬太尼试纸,和教育讲义单。由于其显著的过量病史和舌下丁丙诺啡的依从性挑战,他们开始接受长效注射用丁丙诺啡(LAIB)治疗,每周进行提供者访视和尿液毒理学筛查.与治疗小组合作,他们开始使用应急管理(CM)进行行为治疗,奖励完成任命,预期尿液结果,和成功的药物管理。在接下来的19个月里,到目前为止,他们越来越多地参与护理,并保持节制。对于患有OUD的青少年,LAIB可能是一种有吸引力的替代方案,可以提高依从性并降低反复使用和过量服用的风险。用CM辅助治疗可以改善在MOUD中的保留并且具有治疗StUD的益处。有必要进一步研究,以探索创新,针对OUD青年的社区治疗。
    We present the case of a 14-year-old who established care at our primary care clinic after hospitalization for unintentional fentanyl overdose. They were diagnosed with severe opioid use disorder (OUD) and stimulant use disorder (StUD) and initiated buprenorphine while inpatient. They were then transitioned to the only known outpatient primary care clinic in her county who was actively providing medications for opioid use disorder (MOUD) in adolescents.At the first visit, they reported a history of 20 overdoses, struggling with adherence to buprenorphine and continued opioid cravings. An overdose safety plan was reviewed with them and their parent including providing them naloxone kits, fentanyl test strips, and education handout sheets. Due to their significant overdose history and adherence challenges with sublingual buprenorphine, they were started on long-acting injectable buprenorphine (LAIB) with weekly provider visits and urine toxicology screening. In collaboration with the treatment team, they initiated behavioral treatment with contingency management (CM), with incentives for appointment completion, expected urine results, and successful medication administration. Over the next 19 months, and to date, they have increasingly engaged with care and have remained abstinent. LAIB may be an appealing alternative for adolescents with OUD to improve adherence and reduce risk of recurrent use and overdose. Adjunctive treatment with CM may improve retention in MOUD and have the benefit of treating StUD. There is a need for further research to explore innovative, community-based treatment for youth with OUD.
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  • 文章类型: Journal Article
    随着兴奋剂使用量的大幅增加,尤其是甲基苯丙胺,近年来,本研究旨在根据人格特质和自我效能感对甲基苯丙胺使用者进行聚类,比较他们的心理健康,睡眠质量,以及已识别集群中复发的风险。这项横断面研究是通过对克尔曼沙成瘾治疗中心的501名甲基苯丙胺使用者进行便利抽样,伊朗西部。使用Schwarzer一般自我效能感量表收集数据,祖克曼-库尔曼人格问卷,戈德堡和希勒综合健康问卷(GHQ),祖克曼-库尔曼人格问卷,和兴奋剂复发风险量表(SRRS)。共有501名甲基苯丙胺使用者被分为三个类别,频率为111人(22.2%),298(59.5%),92名(18.4%)成员通过层次聚类分析。第一组参与者的特点是自我效能低,高度神经质,寻求感觉,和侵略性,伴随着低外向性和活动性,低积极健康,高负面健康,睡眠质量低,和药物复发的高风险。第二组的参与者报告了中等水平的自我效能感,神经质,寻求感觉,活动,和侵略性,高外向,和中等程度的心理健康,睡眠质量,和复发的风险。此外,第三组的参与者报告了最高水平的自我效能感,神经质的最低水平,寻求感觉,和侵略性,适度外向和高活性,低复发风险,睡眠质量高,以及高阳性和低阴性健康症状。就上述因素而言,第三个集群与其他两个集群显着不同。这项研究的结果表明,低自我效能感和神经质的存在,寻求感觉,高攻击性会导致心理健康和睡眠质量下降,以及甲基苯丙胺使用者复发的风险增加。
    With the substantial increase in the use of stimulants, especially methamphetamine, in recent years, the present study aimed to cluster methamphetamine users based on personality traits and self-efficacy, and compare their mental health, sleep quality, and the risk of relapse in the identified clusters. This cross-sectional study was conducted through convenience sampling on 501 methamphetamine users in addiction treatment centers in Kermanshah, western Iran. The data were collected using the Schwarzer General Self-Efficacy Scale, Zuckerman-Kuhlman Personality Questionnaire, Goldberg and Hiller General Health Questionnaire (GHQ), Zuckerman-Kuhlman Personality Questionnaire, and Stimulant Relapse Risk Scale (SRRS). A total of 501 methamphetamine users were distinguished into three clusters with frequencies of 111 (22.2%), 298 (59.5%), and 92 (18.4%) members through hierarchical cluster analysis. The participants in the first cluster were characterized by low self-efficacy, high neuroticism, sensation seeking, and aggressiveness, along with low extroversion and activity, low positive health, high negative health, low sleep quality, and high risk of drug relapse. The participants in the second cluster reported moderate levels of self-efficacy, neuroticism, sensation seeking, activity, and aggressiveness, high extroversion, and moderate levels of mental health, sleep quality, and the risk of relapse. Moreover, the participants in the third cluster reported the highest level of self-efficacy, the lowest level of neuroticism, sensation seeking, and aggressiveness, moderate extroversion and high activity, low relapse risk, high sleep quality, as well as high positive and low negative health symptoms. The third cluster was significantly different from the other two clusters in terms of the mentioned factors. The findings of this study suggest that low self-efficacy and the presence of neuroticism, sensation seeking, and high aggressiveness contribute to reduced mental health and sleep quality, as well as an increased risk of relapse in methamphetamine users.
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  • 文章类型: Journal Article
    背景:评估复发风险是治疗甲基苯丙胺使用障碍(MUD)患者的关键步骤。30项兴奋剂复发风险量表(SRRS)最初是在日本开发的,以满足需求。这项研究检查了可靠性,有效性,MUD患者SRRS的中文版和因子结构。
    方法:247例MUD患者自评估中文版SRRS。使用Cronbachα系数和项目间相关性分析来评估内部一致性可靠性。通过验证性因子分析(CFA)确定结构效度,并使用视觉模拟量表(VAS)检查药物渴望和依赖程度量表(SDS)的同时有效性。我们对参与者进行了1年的随访,并根据SRRS中文版评分与随访3、6和12个月内复发率的相关性评估了预测有效性。
    结果:CFA揭示了由四个分量表组成的22项中文版SRRS的令人满意的模型拟合估计。SRRS的四因素22项中文版与Cronbach的阿尔法在0.76至0.92之间具有足够的内部一致性。22项中文版的SRRS评分与VAS和SDS评分以及3、6和12个月内的复发率显着相关。表明该量表具有良好的并发和预测效度。受试者工作特征曲线显示,截止分数为40可以区分具有(SDS评分≥4)和没有(SDS评分<4)甲基苯丙胺依赖性的参与者(曲线下面积=0.71,p<0.01)。
    结论:由四个分量表组成的22项中文版SRRS是评估MUD患者复发风险的有效且可靠的工具。
    BACKGROUND: Evaluating the risk of relapse is a pivotal step in the treatment of patients with methamphetamine use disorder (MUD). The 30-item Stimulant Relapse Risk Scale (SRRS) was originally developed in Japan to meet the demand. This study examined the reliability, validity, and factor structure of the Chinese version of the SRRS for patients with MUD.
    METHODS: 247 patients with MUD self-rated the Chinese version of the SRRS. Cronbach\'s alpha coefficients and inter-item correlation analysis were used to assess the internal consistency reliability. Construct validity was determined through confirmatory factor analysis (CFA), and concurrent validity was examined using the visual analogue scale (VAS) for drug craving and the severity of dependence scale (SDS). We followed the participants for 1 year and assessed the predictive validity based on the correlation of the scores of the Chinese version of the SRRS with the relapse rate within 3, 6, and 12 months of follow-up.
    RESULTS: CFA revealed satisfactory model fit estimates for the 22-item Chinese version of the SRRS that consisted of four subscales. The four-factored 22-item Chinese version of the SRRS had adequate internal consistency with Cronbach\'s alphas ranging from 0.76 to 0.92. The 22-item Chinese version of the SRRS scores were significantly correlated with the VAS and SDS scores as well as the relapse rate within 3, 6, and 12 months, indicating good concurrent and predictive validity of this scale. The receiver operating characteristic curve revealed a cutoff score of 40 could discriminate between participants with (SDS score ≥ 4) and without (SDS score < 4) methamphetamine dependence (area under the curve = 0.71, p < 0.01).
    CONCLUSIONS: The 22-item Chinese version of the SRRS that consists of four subscales is a valid and reliable instrument to assess the relapse risk in patients with MUD.
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  • 文章类型: Journal Article
    这项研究探讨了重复经颅磁刺激(rTMS)对甲基苯丙胺使用障碍(MUD)个体决策能力的影响,以及潜在的潜在心理机制。采用爱荷华州赌博任务(IGT)和计算建模技术,我们评估了50名男性MUD参与者的决策过程(24名接受了rTMS治疗,26个未接受治疗)和39个健康对照(HC)。我们比较了左背外侧前额叶皮质(dlPFC)rTMS治疗前后的改变。结果显示MUD组中IGT的性能较差,特征在于价值加力(VPP)模型中的模型参数异常,包括提高学习率,结果敏感性,和强化学习的重量,伴随着降低的响应一致性和损失厌恶。RTMS治疗显示出降低渴望得分的功效,提高决策能力,并部分恢复正常到MUD队列中的某些模型参数。尽管如此,模型参数的变化与渴望之间没有线性关系。这些发现支持了体细胞标记假说,将dlPFC牵涉到MUD中观察到的决策缺陷中,rTMS可能通过调节这些大脑区域的功能来改善这些缺陷。这项研究不仅为MUD康复提供了新的见解和方法,而且还强调了进一步研究以证实和完善这些发现的必要性。试用注册www。chictr.org.cn标识符:不。ChiCTR17013610。
    This study explores the impact of repetitive transcranial magnetic stimulation (rTMS) on decision-making capabilities in individuals with methamphetamine use disorder (MUD), alongside potential underlying psychological mechanisms. Employing the Iowa Gambling Task (IGT) and computational modeling techniques, we assessed the decision-making processes of 50 male MUD participants (24 underwent rTMS treatment, 26 received no treatment) and 39 healthy controls (HC). We compared pre- and post-rTMS treatment alterations in the left dorsolateral prefrontal cortex (dlPFC). Results revealed inferior performance in the IGT among the MUD group, characterized by aberrant model parameters in the Value-Plus-Perseverance (VPP) model, including heightened learning rate, outcome sensitivity, and reinforcement learning weight, alongside diminished response consistency and loss aversion. RTMS treatment demonstrated efficacy in reducing craving scores, enhancing decision-making abilities, and partially restoring normalcy to certain model parameters in the MUD cohort. Nonetheless, no linear relationship between changes in model parameters and craving was observed. These findings lend support to the somatic marker hypothesis, implicating the dlPFC in the decision-making deficits observed in MUD, with rTMS potentially ameliorating these deficits by modulating the function of these brain regions. This study not only offers novel insights and methodologies for MUD rehabilitation but also underscores the necessity for further research to corroborate and refine these findings. Trial Registration www.chictr.org.cn Identifier: No. ChiCTR17013610.
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  • 文章类型: Case Reports
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  • 文章类型: Journal Article
    与异性恋和HIV阴性同龄人相比,携带HIV的性少数男性(SMM)报告使用甲基苯丙胺的比例明显更高。更大的使用可能与压力源有关(例如,与HIV相关的污名)感染HIV的SMM以及随后的心理和行为后遗症所面临的。我们测试了一个综合的理论模型,该模型由污名之间的路径组成,歧视,童年的性虐待,心理困扰,性强迫性,和认知逃逸在预测携带艾滋病毒的SMM使用甲基苯丙胺方面的作用。
    在423名感染艾滋病毒的SMM中,我们测试了一个结构方程模型,考察了假设与甲基苯丙胺使用直接和间接相关的因素。对人口统计学协变量和抽样偏差进行了调整。
    模型显示出良好的拟合(CFI=0.96,RMSEA=0.01)。异类歧视与心理困扰有关(β=0.39,p<0.001),心理困扰与性强迫有关(β=0.33,p<0.001)。性强迫与认知逃避有关(β=0.31,p<0.001),这与甲基苯丙胺的使用有关(β=0.51,p<0.001)。心理困扰通过性强迫和认知逃避的一系列间接作用与甲基苯丙胺的使用有关(β=0.05,p<0.05)。
    异类歧视导致了感染艾滋病毒的SMM的心理困扰。心理困扰与通过性强迫性和认知回避使用甲基苯丙胺有关。旨在减少感染艾滋病毒的SMM使用甲基苯丙胺的可能性的干预措施应包括针对异性恋和相关心理困扰的应对策略。
    UNASSIGNED: Sexual minority men (SMM) living with HIV report significantly greater methamphetamine use compared with heterosexual and HIV-negative peers. Greater use may be related to stressors (e.g., HIV-related stigma) faced by SMM living with HIV and subsequent psychological and behavioral sequelae. We tested an integrated theoretical model comprised of pathways between stigma, discrimination, childhood sexual abuse, psychological distress, sexual compulsivity, and cognitive escape in predicting methamphetamine use among SMM living with HIV.
    UNASSIGNED: Among 423 SMM living with HIV, we tested a structural equation model examining factors hypothesized to be directly and indirectly associated with methamphetamine use. Analyses were adjusted for demographic covariates and sampling bias.
    UNASSIGNED: The model showed good fit (CFI = 0.96, RMSEA = 0.01). Heterosexist discrimination was associated with psychological distress (β = 0.39, p < 0.001) and psychological distress was associated with sexual compulsivity (β = 0.33, p < 0.001). Sexual compulsivity was associated with cognitive escape (β = 0.31, p < 0.001), which was associated with methamphetamine use (β = 0.51, p < 0.001). Psychological distress was associated with methamphetamine use via serial indirect effects of sexual compulsivity and cognitive escape (β = 0.05, p < 0.05).
    UNASSIGNED: Heterosexist discrimination contributed to psychological distress among SMM living with HIV. Psychological distress is linked to methamphetamine use via sexual compulsivity and cognitive avoidance. Interventions seeking to reduce the likelihood that SMM living with HIV use methamphetamine should include coping strategies specific to heterosexism and related psychological distress.
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  • 文章类型: Journal Article
    目的:观察电针联合棕榈酸帕潘立酮长效注射液(PP-LAI)对甲基苯丙胺(MA)成瘾者戒断症状及神经递质的影响。
    方法:共有109名甲基苯丙胺成瘾者,从2021年10月至2022年10月在医院接受治疗的人被选中。根据随机数表,将患者分为研究组(n=54)和对照组(n=55),其中对照组采用PP-LAI治疗,研究组在对照组基础上采用电针治疗;治疗前及治疗后12个月内采用甲基苯丙胺戒断症状评分量表评定疗效;γ-氨基丁酸,血清素,比较两组的乙酰胆碱值。
    结果:1)两组治疗前MA戒断症状评分无统计学差异(p>0.05);2)研究组治疗3、6个月后MA戒断症状评分与对照组比较差异有统计学意义;3)治疗6个月后研究组多巴胺水平明显高于对照组,和γ-氨基丁酸值及5-羟色胺值均显著低于对照组(p<0.05)。
    结论:电针联合PP-LAI可部分改善甲基苯丙胺成瘾者的戒断症状和焦虑。这是预防戒断症状复发的潜在治疗方法。
    OBJECTIVE: To investigate the effects of electroacupuncture combined with paliperidone palmitate long-acting injection (PP-LAI) on withdrawal symptoms and neurotransmitters in methamphetamine (MA) addicts.
    METHODS: A total of 109 methamphetamine addicts, who were treated in the hospital from October 2021 to October 2022, were selected. According to the random number table, the patients were divided into the study group (n=54) and the control group (n=55), in which the control group was treated with PP-LAI and the study group was treated with electroacupuncture on the basis of the control group; the methamphetamine withdrawal symptom score scale was used to assess the therapeutic effect before treatment and within 12 months after treatment; the changes of brain neurotransmitters dopamine, γ-aminobutyric acid, serotonin, acetylcholine values were compared between the two groups.
    RESULTS: 1) There was no statistical difference in MA withdrawal symptom scores between the two groups before treatment (p>0.05); 2) MA withdrawal symptom scores have a statistically significant difference between the study group and the control group after 3 and 6 months of treatment; 3) dopamine levels in the study group were significantly higher than those in the control group after 6 months of completion of treatment, and γ-aminobutyric acid values and 5- serotonin values in the study group were significantly lower than those in the control group (p<0.05).
    CONCLUSIONS: Electroacupuncture combined with PP-LAI can partially improve the withdrawal symptoms and anxiety of methamphetamine addicts. This is a potential treatment for preventing relapse of withdrawal symptoms.
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  • 文章类型: Clinical Trial Protocol
    背景:没有批准的甲基苯丙胺使用障碍的药物疗法。两项初步的2期随机对照试验发现了米氮平,四环抗抑郁药,有效减少甲基苯丙胺的使用。拟议的Tina试验是第一个3期安慰剂对照随机试验,旨在研究米氮平作为甲基苯丙胺使用障碍的门诊药物疗法的有效性和安全性。
    方法:这是一个多站点3期随机,双盲,安慰剂对照平行试验。参与者被随机分配(1:1)接受米氮平(30毫克/天,持续12周)或匹配的安慰剂,作为一种带回家的药物。目标人群是340名年龄在18-65岁之间,患有中度至重度甲基苯丙胺使用障碍的人。该试验正在澳大利亚的门诊酒精和其他药物治疗诊所进行。主要结果是在第12周的过去4周内自我报告的甲基苯丙胺使用天数。次要结果是甲基苯丙胺阴性口腔液样本,抑郁症状,睡眠质量,艾滋病毒风险行为和生活质量。其他结果包括安全性(不良事件),耐受性,卫生服务使用。使用安装在药瓶上的MEMS®SmartCaps监测药物依从性。
    结论:该试验将提供有关米氮平作为常规临床实践中门诊药物治疗甲基苯丙胺使用障碍的安全性和有效性的信息。如果发现安全有效,本试验将支持将甲基苯丙胺使用障碍作为米氮平处方的治疗适应症的申请.
    背景:澳大利亚和新西兰临床试验注册ACTRN12622000235707。2022年2月9日注册
    BACKGROUND: There are no approved pharmacotherapies for methamphetamine use disorder. Two preliminary phase 2 randomised controlled trials have found mirtazapine, a tetracyclic antidepressant, to be effective in reducing methamphetamine use. The proposed Tina Trial is the first phase 3 placebo-controlled randomised trial to examine the effectiveness and safety of mirtazapine as an outpatient pharmacotherapy for methamphetamine use disorder.
    METHODS: This is a multi-site phase 3 randomised, double-blind, placebo-controlled parallel trial. Participants are randomly allocated (1:1) to receive either mirtazapine (30 mg/day for 12 weeks) or matched placebo, delivered as a take-home medication. The target population is 340 people aged 18-65 years who have moderate to severe methamphetamine use disorder. The trial is being conducted through outpatient alcohol and other drug treatment clinics in Australia. The primary outcome is measured as self-reported days of methamphetamine use in the past 4 weeks at week 12. Secondary outcomes are methamphetamine-negative oral fluid samples, depressive symptoms, sleep quality, HIV risk behaviour and quality of life. Other outcomes include safety (adverse events), tolerability, and health service use. Medication adherence is being monitored using MEMS® Smart Caps fitted to medication bottles.
    CONCLUSIONS: This trial will provide information on the safety and effectiveness of mirtazapine as a pharmacotherapy for methamphetamine use disorder when delivered as an outpatient medication in routine clinical practice. If found to be safe and effective, this trial will support an application for methamphetamine use disorder to be included as a therapeutic indication for the prescription of mirtazapine.
    BACKGROUND: Australian and New Zealand Clinical Trials Registry ACTRN12622000235707. Registered on February 9, 2022.
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