A Double-blind, Randomized, Placebo Controlled Clinical Trial to Evaluate the Efficacy of Orexigenic Therapy With Delta-9-tetrahydrocannabinol in Advanced Cancer Patients With Chemosensory Abnormalities - a Pilot Study

To investigate delta-9-tetrahydrocannabinol's (THC) ability to increase food intake and improve food enjoyment for advanced cancer patients with taste and/or smell (chemosensory) abnormalities.

开始日期2006-08-01

申办/合作机构

Alberta Health Services

[+1]

NCT00153192 / Completed临床2/3期IIT

A Randomized Controlled Clinical Trial of Dronabinol (Marinol) vs Placebo as Add-on Therapy For Patients on Opioids for Chronic Pain

The purpose of this research study is to determine if Marinol alleviates pain in patients with chronic pain who are currently taking opioids.
The study begins with a 2-hour initial visit followed by three 8-hour appointments at Brigham and Women's Hospital. At each 8-hour visit, patients receive a dose of medication and complete surveys relating to pain.
During the first visit a brief examination and a few surveys about pain, quality of life, and medical history are given. The study doctor then determines if the participant continues to qualify for the study.
If qualified for the study, patients receive a daily diary to record pain levels and pain medications; this will take about 5 minutes each day. After completion of the diary, patients begin the 8-hour visits.
Patients visit the Pain Trials Center three times to receive study medication. After taking the study medication, participants remain in the clinic for 8 hours to complete hourly surveys about pain and pain relief.
Subsequent to these visits, patients may enter a 1-month extension where Marinol is taken at home, and pain levels are recorded in a diary. Participants can change the dose of study drug to better control pain and side effects, after speaking with study staff. The study then concludes with a final 30-minute visit to summarize the participant's experience in the clinical trial.

开始日期2001-04-01

申办/合作机构

The Brigham & Women's Hospital, Inc.

[+1]

100 项与 Dronabinol Hemisuccinate 相关的临床结果

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100 项与 Dronabinol Hemisuccinate 相关的转化医学

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100 项与 Dronabinol Hemisuccinate 相关的专利（医药）

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项与 Dronabinol Hemisuccinate 相关的文献（医药）

2010-07-01·Archives of Toxicology2区 · 医学

Dopaminergic neurotoxicity following pulmonary exposure to manganese-containing welding fumes

2区 · 医学

Article

作者: Bean T. Chen ; Gary X. Lin ; Joleen M. Soukup ; Jenny R. Roberts ; Krishnan Sriram ; Amy M. Jefferson ; Andrew J. Ghio ; Rebecca S. Chapman ; James M. Antonini

The potential for development of Parkinson's disease (PD)-like neurological dysfunction following occupational exposure to aerosolized welding fumes (WF) is an area of emerging concern. Welding consumables contain a complex mixture of metals, including iron (Fe) and manganese (Mn), which are known to be neurotoxic. To determine whether WF exposure poses a neurological risk particularly to the dopaminergic system, we treated Sprague-Dawley rats with WF particulates generated from two different welding processes, gas metal arc-mild steel (GMA-MS; low Mn, less water-soluble) and manual metal arc-hard surfacing (MMA-HS; high Mn, more water-soluble) welding. Following repeated intratracheal instillations (0.5 mg/rat, 1/week x 7 weeks) of GMA-MS or MMA-HS, elemental analysis and various molecular indices of neurotoxicity were measured at 1, 4, 35 or 105 days after last exposure. MMA-HS exposure, in particular, led to increased deposition of Mn in striatum and midbrain. Both fumes also caused loss of tyrosine hydroxylase (TH) protein in the striatum (~20%) and midbrain (~30%) by 1 day post-exposure. While the loss of TH following GMA-MS was transient, a sustained loss (34%) was observed in the midbrain 105 days after cessation of MMA-HS exposure. In addition, both fumes caused persistent down-regulation of dopamine D2 receptor (Drd2; 30-40%) and vesicular monoamine transporter 2 (Vmat2; 30-55%) mRNAs in the midbrain. WF exposure also modulated factors associated with synaptic transmission, oxidative stress, neuroinflammation and gliosis. Collectively, our findings demonstrate that repeated exposure to Mn-containing WF can cause persistent molecular alterations in dopaminergic targets. Whether such perturbations will lead to PD-like neuropathological manifestations remains to be elucidated.

2010-06-01·AAPS PharmSciTech3区 · 医学

Preparation and Characterization of Inclusion Complexes of a Hemisuccinate Ester Prodrug of Δ9-Tetrahydrocannabinol with Modified Beta-Cyclodextrins

3区 · 医学

Article

作者: Michael A. Repka ; Soumyajit Majumdar ; Mitchell A. Avery ; Sampada B. Upadhye ; Mahmoud A. ElSohly ; Swapnil J. Kulkarni ; Waseem Gul

Delta(9)-Tetrahydrocannabinol hemisuccinate (THC-HS), an ester prodrug of Delta(9)-tetrahydrocannabinol (THC) has been investigated for its potential to form inclusion complexes with modified synthetic beta-cyclodextrins (CDs). Phase solubility studies were performed to determine the stoichiometric ratio of complexation of THC-HS with random methylated beta-cyclodextrin (RAMEB) and 2-hydroxypropyl beta-cyclodextrin (HPBCD). THC-HS/RAMEB and THC-HS/HPBCD solid systems were prepared by lyophilization and the lyophilized complexes were characterized by Fourier transform infrared (FT-IR) spectroscopy, proton nuclear magnetic spectroscopy, and molecular modeling techniques. The formation of inclusion complexes of THC-HS/RAMEB and THC-HS/HPBCD was demonstrated by an A(L) type curve with the slopes less than unity by the phase solubility method. The association constants for THC-HS/RAMEB and THC-HS/HPBCD were found to be 562.48 and 238.83 M(-1), respectively. The stoichiometry of both of the complexes was found to be 1:1 as determined from the Job's plot. This was confirmed by (1)H NMR and FT-IR techniques. The results obtained from the molecular modeling studies were in accordance with the data obtained from nuclear magnetic resonance and FT-IR. The docking studies revealed the most probable mode of binding of THC-HS with RAMEB in which the alkyl chain was submerged in the hydrophobic pocket of the CD molecule and hydrogen bonding interactions were observed between the hemisuccinate ester side chain of THC-HS and the rim hydroxy groups of RAMEB. The solubility of THC-HS was significantly higher in RAMEB compared to HPBCD. Solid dispersions of THC-HS with CDs will be further utilized to develop oral formulations of THC-HS with enhanced bioavailability.

2007-08-01·Spinal Cord3区 · 医学

The treatment of spasticity with Δ9-tetrahydrocannabinol in persons with spinal cord injury

3区 · 医学

Article

作者: U Hagenbach ; R Brenneisen ; F Grotenhermen ; N Ghafoor ; J M Berger ; S Luz ; M Mäder

STUDY DESIGNOpen label study to determine drug dose for a randomized double-blind placebo-controlled parallel study.OBJECTIVESTo assess the efficacy and side effects of oral Delta(9)-tetrahydrocannabinol (THC) and rectal THC-hemisuccinate (THC-HS) in SCI patients.SETTINGREHAB Basel, Switzerland.METHODTwenty-five patients with SCI were included in this three-phase study with individual dose adjustment, each consisting of 6 weeks. Twenty-two participants received oral THC open label starting with a single dose of 10 mg (Phase 1, completed by 15 patients). Eight subjects received rectal THC-HS (Phase 2, completed by seven patients). In Phase 3, six patients were treated with oral THC and seven with placebo. Major outcome parameters were the spasticity sum score (SSS) using the Modified Ashworth Scale (MAS) and self-ratings of spasticity.RESULTSMean daily doses were 31 mg with THC and 43 mg with THC-HS. Mean SSS for THC decreased significantly from 16.72 (+/-7.60) at baseline to 8.92 (+/-7.14) on day 43. Similar improvement was seen with THC-HS. We observed a significant improvement of SSS with active drug (P=0.001) in the seven subjects who received oral THC in Phase 1 and placebo in Phase 3. Major reasons for drop out were increase of pain and psychological side effects.CONCLUSIONTHC is an effective and safe drug in the treatment of spasticity. At least 15-20 mg per day were needed to achieve a therapeutic effect.

项与 Dronabinol Hemisuccinate 相关的新闻（医药）

2022-09-18

·E药经理人

立陶宛TOP5 Biotech盘点：成立不足5年，CRISPR Cas9先驱参与，聚焦合成生物学、基因编辑等

尽管这是一个人口只有不到300万的国家，但立陶宛在生命科学领域的实力却不容小觑。在立陶宛，目前有超过400家生命科学领域的公司，而且这个数字每年都在增长。虽然该国仍是一个新兴的生物技术创业中心，但立陶宛已经拥有了许多冉冉升起的新星。在立陶宛生物技术协会的帮助下，我们列出了立陶宛五家领先的生物技术初创公司，它们的总部都位于立陶宛首都维尔纽斯。1. Biomatter Designs成立时间：2018Biomatter Designs 使用合成生物学和机器学习来设计用于各种应用的蛋白质，主要包括蛋白质药物和工业酶。在蛋白质工程领域，经典方法主要是依赖于筛选现有蛋白质。但这样的方法既昂贵又耗时。而Biomatter Designs的方法是让计算机分析来自天然蛋白质的大量数据并了解它们的行为方式，然后将这些知识应用于设计合成蛋白质。设计合成后的蛋白质，可能比自然界中的蛋白质更有效。该公司在2021年初的种子轮融资中，筹集了 511000 美元（约合500000 欧元）为其研究提供资金。2. CasZyme成立时间：2017基因编辑工具CRISPR-Cas9曾一度吸引了整个生命科学领域的投资者和公司。该技术比以往任何时候，都更容易对基因组进行精确编辑，以应用于制药和工业生物技术领域。然而，该技术早期的几代人，在可以进行编辑的位置方面存在限制。为了解决这一问题，CasZyme扩大提供了可以剪切DNA的Cas 蛋白的范围，让基因组有了更多可以进行编辑的位点。CasZyme创始团队的一位知名成员是立陶宛维尔纽斯大学的分子生物学家Virginijus Šikšnys。Šikšnys是CRISPR-Cas9 的先驱，他的团队与诺贝尔奖获得者Emmanuelle Charpentier 和Jennifer Doudna同时独立开发了该技术。3. Droplet Genomics成立时间： 2016Droplet Genomics将生命科学、工程和机器学习融合在一起，以加速生命科学研究和药物发现。特别是，该公司使用荧光显微镜和微流体技术，使研究人员能够在数百万个体积达到纳米级的微小液滴中进行分子生物学实验。该技术的应用包括能够计算样品中单个分子的数量并测量它们与单个细胞的相互作用。Droplet Genomics旨在将这一工艺应用于个性化医疗的发展。2021 年初，Droplet Genomics 在种子轮融资中筹集了100万美元（约合100 万欧元），用于将其技术商业化。4. Delta Biosciences成立时间：2020Delta Biosciences成立于COVID-19大流行的第一个阶段，旨在开发Covid治疗方法。为了加快新药的发现，这家初创公司部署了广泛的专业知识，包括微流体、分子合成、下一代测序、纳米工程和数据科学。其部分筛选技术源自欧洲核子研究组织 (CERN) 的电子创新，该组织以在瑞士的物理研究而闻名。Delta Biosciences是非营利性COVID Moonshot计划的一部分。该计划正在开发用于治疗COVID-19的开源药物，这些药物可以造福世界上目前药物无法触及的部分地区。Moonshot的第一批药物正朝着临床试验方向努力。2021 年初，Delta Biosciences从欧盟获得了约 100 万美元（约合100 万欧元）的赠款，为其药物发现技术提供资金。5. Sanobiotec成立时间：2018大麻素药物在制药和化妆品行业中的应用越来越广泛，尤其是大麻中最知名的成分：四氢大麻酚 (THC) 和大麻二酚 (CBD)。Sanobiotec 正在开发大麻素药物，在大麻酚、大麻色素和大麻二酚酸领域开展多个研究项目。其中包括开发用于治疗癌症等疾病的合成和天然大麻素，以及在转基因酵母中制造大麻素药物。内容编译自：https://www.labiotech.eu/best-biotech/lithuania-biotech-startups-top/

100 项与 Dronabinol Hemisuccinate 相关的药物交易

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