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Making pharmacotherapy trials for substance use disorder more efficient: Leveraging real-world data capture to maximize power and expedite the medication development pipeline.提高物质使用障碍药物治疗试验的效率:利用真实世界数据采集来最大化效能并加速药物研发进程。
Drug Alcohol Depend. 2020 Apr 1;209:107897. doi: 10.1016/j.drugalcdep.2020.107897. Epub 2020 Feb 5.
2
Correlation of Breath and Blood Δ-Tetrahydrocannabinol Concentrations and Release Kinetics Following Controlled Administration of Smoked Cannabis.吸食大麻后呼气和血液中 Δ-四氢大麻酚浓度的相关性及其释放动力学。
Clin Chem. 2019 Sep;65(9):1171-1179. doi: 10.1373/clinchem.2019.304501. Epub 2019 Jul 11.
3
Relationships between marijuana use, severity of marijuana-related problems, and health-related quality of life.大麻使用、大麻相关问题严重程度与健康相关生活质量之间的关系。
Psychiatry Res. 2019 Sep;279:237-243. doi: 10.1016/j.psychres.2019.03.010. Epub 2019 Mar 13.
4
Exogenous progesterone for cannabis withdrawal in women: Feasibility trial of a novel multimodal methodology.外源性孕激素治疗女性大麻戒断:一种新的多模态方法的可行性试验。
Pharmacol Biochem Behav. 2019 Apr;179:22-26. doi: 10.1016/j.pbb.2019.01.008. Epub 2019 Jan 31.
5
Pharmacotherapies for cannabis dependence.大麻依赖的药物治疗
Cochrane Database Syst Rev. 2019 Jan 28;1(1):CD008940. doi: 10.1002/14651858.CD008940.pub3.
6
Tobacco and cannabis co-use: Drug substitution, quit interest, and cessation preferences.烟草与大麻共同使用:药物替代、戒烟意愿及戒烟偏好
Exp Clin Psychopharmacol. 2019 Jun;27(3):265-275. doi: 10.1037/pha0000244. Epub 2018 Dec 17.
7
Systematic review of outcome domains and measures used in psychosocial and pharmacological treatment trials for cannabis use disorder.系统评价心理社会和药物治疗大麻使用障碍试验中使用的结局领域和测量方法。
Drug Alcohol Depend. 2019 Jan 1;194:500-517. doi: 10.1016/j.drugalcdep.2018.10.020. Epub 2018 Nov 15.
8
Efficacy and safety of a fatty acid amide hydrolase inhibitor (PF-04457845) in the treatment of cannabis withdrawal and dependence in men: a double-blind, placebo-controlled, parallel group, phase 2a single-site randomised controlled trial.脂肪酸酰胺水解酶抑制剂(PF-04457845)治疗男性大麻戒断和成瘾的疗效及安全性:一项双盲、安慰剂对照、平行组、2a期单中心随机对照试验
Lancet Psychiatry. 2019 Jan;6(1):35-45. doi: 10.1016/S2215-0366(18)30427-9. Epub 2018 Dec 6.
9
Reduction in Cannabis Use and Functional Status in Physical Health, Mental Health, and Cognition.减少大麻使用与身体健康、心理健康和认知功能的关系。
J Neuroimmune Pharmacol. 2018 Dec;13(4):479-487. doi: 10.1007/s11481-018-9813-6. Epub 2018 Oct 3.
10
Treatment for Alcohol Use Disorder: Progress in Predicting Treatment Outcome and Validating Nonabstinent End Points.酒精使用障碍的治疗:预测治疗结果及验证非戒酒终点的进展
Alcohol Clin Exp Res. 2018 Oct;42(10):1874-1879. doi: 10.1111/acer.13846. Epub 2018 Aug 9.

在临床试验中测量个体内大麻使用量的减少:方法学挑战综述

Measuring Within-Individual Cannabis Reduction in Clinical Trials: A Review of the Methodological Challenges.

作者信息

Tomko Rachel L, Gray Kevin M, Huestis Marilyn A, Squeglia Lindsay M, Baker Nathaniel L, McClure Erin A

机构信息

Department of Psychiatry and Behavioral Sciences, Medical university of South Carolina.

Institute of Emerging Health Professions, Thomas Jefferson University.

出版信息

Curr Addict Rep. 2019 Dec;6(4):429-436. doi: 10.1007/s40429-019-00290-y. Epub 2019 Nov 19.

DOI:10.1007/s40429-019-00290-y
PMID:32133273
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7055684/
Abstract

PURPOSE

Cannabis abstinence traditionally is the primary outcome in cannabis use disorder (CUD) treatment trials. Due to the changing legality of cannabis, patient goals, and preliminary evidence that suggests individuals who reduce their cannabis use may show functional improvements, cannabis reduction is a desirable alternative outcome in CUD trials. We review challenges in measuring cannabis reduction and the evidence to support various definitions of reduction.

FINDINGS

Reduction in number of cannabis use days was associated with improvements in functioning across several studies. Reductions in quantity of cannabis used was inconsistently associated with improvements in functioning, though definitions of quantity varied across studies. Different biomarkers may be used depending on the reduction outcome.

CONCLUSIONS

Biologically-confirmed reductions in frequency of cannabis use days may represent a viable endpoint in clinical trials for cannabis use disorder. Additional research is needed to better quantify reduction in cannabis amounts.

摘要

目的

传统上,大麻戒断是大麻使用障碍(CUD)治疗试验的主要结果。由于大麻合法性的变化、患者目标以及初步证据表明减少大麻使用的个体可能会出现功能改善,大麻减少是CUD试验中一个理想的替代结果。我们回顾了衡量大麻减少的挑战以及支持各种减少定义的证据。

研究结果

在多项研究中,大麻使用天数的减少与功能改善相关。尽管不同研究中对大麻使用量的定义各不相同,但大麻使用量的减少与功能改善之间的关联并不一致。根据减少结果的不同,可以使用不同的生物标志物。

结论

经生物学确认的大麻使用天数频率降低可能是大麻使用障碍临床试验中的一个可行终点。需要进一步的研究来更好地量化大麻用量的减少。