在临床试验中对大麻素产品的研究Trials.gov:一个范围审查
Margaret Haney1, Ziva D Cooper2, Hannah VanLaanen3
1Columbia University Irving Medical Center, New York State Psychiatric Institute, New York, NY, USA.
Pharmaceutical medicine
|December 10, 2025
概括
这次对临床试验的审查发现,大多数大麻素研究都是小型的,处于早期阶段. 未来的研究应该集中在治疗性大麻素产品的更大规模的安慰剂对照试验上.
科学领域:
- 临床研究 临床研究
- 药理学 药理学是指药理学的学科.
- 公共卫生 公共卫生
背景情况:
- 人们对大麻素制品的治疗应用越来越感兴趣.
- 独特的监管障碍需要清楚地了解当前的研究.
- 需要对注册的关于大麻素干预的临床研究进行描述.
研究的目的:
- 在clinicaltrials.gov注册的关于涉及基于大麻素的干预措施的研究进行范围审查.
- 调查这些注册研究的特点.
主要方法:
- 根据PRISMA-ScR指南进行范围审查.
- 从clinicaltrials.gov提取的数据用于使用经批准的药物,化合物,大麻或大麻的研究.
- 分析包括干预类型,疾病状态,研究阶段,参与者数量,持续时间,赞助商和趋势.
主要成果:
- 分析了来自825项独特研究的879项干预措施.
- 最常见的干预措施:化合物 (43.6%),批准药物 (32.7%),大麻 (20.3%),大麻 (3.5%).
- 共同的研究领域:心理障碍 (20.6%),病理状况 (18.5%) 和神经系统疾病 (15.4%).
- 大多数是早期阶段 (63.2%),小 (<50名参与者,54.2%) 和由学术机构赞助 (70.5%).
- 从2013年到2019年,提交研究的数量显著增加.
结论:
- 注册的大麻素研究通常是早期的,随机的和小的.
- 研究结果强调了各种疾病中大麻素研究的异质性.
- 强调需要进行更大规模的安慰剂对照试验,以推进治疗理解.
相关概念视频
Clinical Trials: Overview
4.5K
Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
4.5K
Clinical Trials
10.1K
Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
There are four phases in a clinical trial. A phase one...
10.1K
Chemotherapy-Induced Nausea and Vomiting: Cannabinoids
651
Tetrahydrocannabinol (THC) is a phytocannabinoid that primarily interacts with the CB1 receptor, a type of G protein-coupled receptor (GPCR) predominantly in and around the chemoreceptor trigger zone (CTZ) and emetic center. THC also blocks the serotonin receptor activity in the dorsal vagal complex (DVC) by inhibiting serotonin release. THC exerts its anti-emetic effects through these interactions, which are beneficial for patients undergoing chemotherapy.
Two synthetic agonists of THC,...
Two synthetic agonists of THC,...
651
Preclinical Development: Overview
5.7K
Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...
5.7K
CNS Stimulants: Cocaine, Amphetamines and Cannabinoids
741
CNS stimulants, such as cocaine, amphetamines, and cannabinoids, have varying structures and mechanisms of action that lead to different therapeutic effects and side effects. Cocaine, with its molecular formula C17H21NO4, is a tropane alkaloid and a tertiary amino compound. It has two chemical forms: the hydrochloride salt and the "freebase." The former is in powder form, while the latter involves removing the hydrochloride salt to create a form that can be smoked. Cocaine exerts its...
741
Bioequivalence studies: Biowaivers
206
Body:In certain scenarios, in vitro dissolution tests can replace in vivo bioequivalence studies. This is particularly true when a drug product, though available in varying strengths, maintains proportional similarity in its active and inactive ingredients. In such cases, the need for in vivo bioequivalence studies for lower strength variants may be waived, provided dissolution tests and in vivo studies on the highest strength yield satisfactory results.Bioequivalence can be indicated through...
206


