A Phase I, Open Label, Study of 3,4-Methylenedioxymethamphetamine (MDMA) Tolerability and Pharmacokinetics in Subjects With Moderate Hepatic Impairment Compared to Matched Control Subjects With Normal Hepatic Function

The goal of this clinical trial to learn how MDMA is processed in people with abnormal liver function.
The main questions it aims to answer are:
Do people with abnormal liver function experience greater absorption of MDMA? Does the dose of MDMA need to be adjusted in people with abnormal liver function?
Researchers will compare people with abnormal liver function to people with normal liver function.
Participants will receive a single dose of MDMA then undergo periodic vitals measurements. They will remain at the study site for two more days undergoing more vitals measurements and having subjective effects and adverse events measured.

Start Date29 Mar 2026

Sponsor / Collaborator

Lykos Therapeutics, Inc.Startup

NCT04454684

/ WithdrawnPhase 2

An Open-Label, Multi-Site Phase 2 Study of the Safety and Feasibility of MDMA-Assisted Psychotherapy for Eating Disorders

The goal of this clinical trial is to learn if MDMA-assisted therapy and caregiver involvement are safe and effective in treating female participants with eating disorders.
The main question it aims to answer is: Does MDMA-assisted therapy reduce eating disorder symptoms?
Participants will undergo two non-drug preparatory therapy sessions and their caregiver will undergo one non-drug preparatory therapy session. Participants will undergo three sessions of MDMA-assisted therapy followed by non-drug integrative therapy sessions alone as well as together with their caregiver.

Start Date01 Feb 2026

Sponsor / Collaborator

Lykos Therapeutics, Inc.Startup

NCT06353282

/ Not yet recruitingPhase 2IIT

3, 4-methylenedioxymethamphetamine (MDMA) for Treatment-resistant Post-traumatic Stress Disorder (PTSD) in Adolescents

The primary objective of this study is to determine the safety and feasibility of 3,4-methylenedioxymethamphetamine (MDMA) -assisted psychotherapy to treat resistant post-traumatic stress disorder (PTSD). The secondary objectives are the exploration of effectiveness for treatment-resistant PTSD, symptoms of depression, and anxiety symptoms.

Start Date01 Jul 2025

Sponsor / Collaborator

University of California, Los Angeles

100 Clinical Results associated with Methylenedioxymetamfetamine

100 Translational Medicine associated with Methylenedioxymetamfetamine

100 Patents (Medical) associated with Methylenedioxymetamfetamine

9,445

Literatures (Medical) associated with Methylenedioxymetamfetamine

13 Apr 2025·ANALYTICAL LETTERS

Influence of the Capillary Design and Conditions upon the Transmission Efficiency of a Portable Ion Trap Mass Spectrometer

Author: Hong, Huanhuan ; Chen, La ; Wen, Luhong ; Li, Gangqiang ; Kuang, Lvying ; Huang, Zhixiang

The capillary is a widely used atm. pressure interface in mass spectrometers that may be heated to enhance the desolvation of ions.In this study, the ion transmission efficiency of a portable ion trap mass spectrometer was investigated using capillaries with different inner diameters and temperatures, different vacuum pressures, and different ion optics designs.Due to the incomplete desolvation and the space charge effect inside the miniature ion funnel, the increase of ion intensities with the inner diameter of the capillary leveled off when the inner diameter of the capillary was larger than 0.37 mm.With the increase of capillary temperature, the ion intensities first increase due to better desolvation and then decrease due to greater diffusion loss.The optimal temperature of the capillary increases with the inner diameter of the capillary and the mass-to-charge ratio of ion.In addition, the pressures of different vacuum stages also exerted remarkable effects on the sensitivity of the portable mass spectrometer.From the perspective of instrument miniaturization, optimal transmission efficiency can be obtained when the first-stage vacuum pressure is maintained from 4 to 6 mbar.For a capillary with an inner diameter of 0.37 mm, the background of mass spectrum can be significantly reduced by replacing the pinhole behind the ion funnel with an off-axis skimmer.

01 Apr 2025·CHEMICO-BIOLOGICAL INTERACTIONS

The role of mitochondrial dysfunction and calcium dysregulation in 2C-I and 25I-NBOMe-induced neurotoxicity

Article

Author: Barbosa, Daniel José ; Silva, Renata ; Gil-Martins, Eva ; Cagide, Fernando ; Borges, Fernanda ; Borer, Ana ; Chavarria, Daniel ; Fernandes, Carlos ; Remião, Fernando

New psychoactive substances (NPS) are designed to evade legal regulation while mimicking the effects of classic illicit drugs such as 3,4-methylenedioxymethamphetamine (MDMA). This category includes phenethylamine derivatives, such as the psychedelic 2C and NBOMe drugs. Given the lack of data regarding the toxicological profile of these substances, the goal of this study was to evaluate the neurotoxicity of 2C-I and 25I-NBOMe and explore their neurotoxic pathways. Lower EC₅₀ values, in both NR uptake and MTT reduction assays in differentiated SH-SY5Y cells and primary rat cortical cultures, revealed that 25I-NBOMe is significantly more cytotoxic than 2C-I, likely due to its higher lipophilicity. Both drugs triggered severe mitochondrial dysfunction, characterized by decreased intracellular ATP levels and mitochondrial membrane depolarization, although no significant changes in intracellular ROS/RNS levels were observed. Additionally, 25I-NBOMe increased the intracellular Ca²⁺ levels. Apoptosis was an observed mechanism of cell death for both drugs, as demonstrated by a significant increase in the number of cells undergoing early apoptosis (AnV⁺/PI^-) and late apoptosis/necrosis (AnV⁺/PI⁺). However, only 2C-I induced autophagy and strongly triggered caspase-3 activation. This suggests that 2C-I induces caspase-3-dependent apoptosis, whereas 25I-NBOMe may also induce apoptosis through a caspase-3-independent pathway, possibly involving increased intracellular Ca²⁺ levels and direct mitochondrial damage. These findings underscore the complex interplay between mitochondrial dysfunction, calcium dysregulation, and cell death pathways, highlighting the central role of mitochondria in the cytotoxicity of 2C-I and 25I-NBOMe.

01 Mar 2025·Neuropsychopharmacology reports

Effects of 3,4‐methylenedioxymethamphetamine on neural activity in the nucleus accumbens of male mice engaged in social behavior

Article

Author: Sasaki, Yuki ; Nishitani, Naoya ; Kaneda, Katsuyuki

Abstract:

3,4‐methylenedioxymethamphetamine (MDMA), a commonly abused recreational drug, induces prosocial effects such as increased sociability and empathy. The nucleus accumbens (NAc) has been suggested to play a crucial role in these MDMA‐mediated prosocial effects. However, the relationship between social behavior and NAc neural activity, and the effects of MDMA on this relationship, remain unknown. In this study, we measured NAc neural activity using fiber photometry and classified the behaviors of mice at times of transient increases in NAc neural activity during the social approach test (SAT). We found that NAc neural activity transiently increased at the onset of turning toward and sniffing novel mice during the SAT, although the frequency of turning was relatively low. We then examined the effects of MDMA on behavior and NAc neural activity and found that MDMA decreased the duration of sniffing per bout but did not alter NAc neural activity at the onset of turning toward or sniffing novel mice. These results suggest that MDMA does not affect the transient increase in NAc neural activity at the onset of social behaviors.

380

News (Medical) associated with Methylenedioxymetamfetamine

03 Mar 2025

·www.drugs.com

Death Risk Doubled For ER Patients On Psychedelics

MONDAY, March 3, 2025 -- People who land in the ER after using hallucinogens are more than twice as likely to die in a handful of years, a new study says. Psychedelics users treated at a hospital are 2.6 times more likely than average folks to die from any cause within five years, researchers reported in the Canadian Medical Association Journal . They specifically were more likely to die by suicide, cancer, lung disease and overdose compared to the general public, researchers found. “The findings highlight the need for ongoing investigation of and communication about both potential benefits and risks from hallucinogen use, particularly use outside clinical trial settings, given rapid increases in general population use,” senior researcher Dr. Marco Solmi , an associate professor of psychiatry at the University of Ottawa, said in a news release. The use of hallucinogens like ketamine , psilocybin, LSD, ayahuasca and ecstasy has rapidly increased since the mid-2010s, driven by clinical trials supporting their potential use in treating mental health and substance use disorders, researchers said in background notes. The percentage of U.S. residents reporting that they used hallucinogens more than doubled from nearly 4% in 2016 to almost 9% in 2021, researchers said. However, there isn’t much data on whether these drugs could increase a person’s risk of death when they’re used outside carefully controlled settings, researchers said. For the new study, researchers analyzed records on ER visits or hospitalizations among more than 11.4 million people 15 and older living in Ontario, Canada from 2006 to 2022. Overall, researchers found a 2.6-fold increased risk of early death among people who required treatment after using a hallucinogen. The risk was even higher -- 3.2-fold -- after researchers excluded people who had mental health or substance use disorders, results show. People who required care for hallucinogen use also had increased risks related to specific causes of death: These risks were higher than those of people who sought hospital care linked to alcohol consumption, but lower than people who needed care for opioid or stimulant use, researchers noted. Psychedelics might increase a person’s risk of suicide if they’re used outside a clinical setting researchers said. People taking hallucinogens also might be liable to take other drugs, increasing their risk of overdose. Further, people who needed hospital care for hallucinogen use were more likely to live in low-income neighborhoods, to have been homeless, to have chronic health problems, and to have been treated for a mental health or substance use disorder in the previous three years, researchers added. “Despite the growing popularity of hallucinogen use, we know surprisingly little about potential adverse effects of hallucinogens, such as mortality risks,” lead researcher Dr. Daniel Myran , research chair in social accountability at the University of Ottawa, said in a news release. “Contemporary clinical trials have not observed any short-term increase in risk of severe adverse events, including death, for trial participants,” Myran said. “However, these studies involve careful supervision and therapy for trial participants and exclude people at high risk of adverse outcomes.” Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

04 Feb 2025

·www.globenewswire.com

SciSparc-Clearmind Collaboration Leads to Publication of Patent for Binge Behaviour Combination Treatment in Mexico

TEL AVIV, Israel, Feb. 04, 2025 (GLOBE NEWSWIRE) -- SciSparc Ltd. (Nasdaq: SPRC) ("Company" or "SciSparc"), a specialty clinical-stage pharmaceutical company focusing on the development of therapies to treat disorders and rare diseases of the central nervous system, announced today that as part of its ongoing collaboration with Clearmind Medicine Inc. (“Clearmind”) (Nasdaq: CMND) (FSE: CWY), a biotechnology company focused on discovery and development of novel psychedelic-derived therapeutics to solve major under-treated mental health problems, Clearmind has announced the publication of a patent application in Mexico for the innovative combination of 3,4-Methylenedioxymethamphetamine (MDMA) with N-Acylethanolamines. The patent refers to SciSparc’s innovative combination therapy of N-Acylethanolamines and Clearmind’s MEAI, (5-methoxy-2-aminoindane) addressing binge behaviour, including alcohol consumption, eating, tobacco consumption, shopping and sexual conduct. Under this collaboration, the two companies are researching innovative combination therapies that integrate psychedelic molecules with the N-Acylethanolamines family, including Palmitoylethanolamide (PEA). To date,13 patents related to this collaboration have been filed with the U.S. Patent and Trademark Office, as well as in several other global jurisdictions. About SciSparc Ltd. (Nasdaq: SPRC): SciSparc Ltd. is a specialty clinical-stage pharmaceutical company led by an experienced team of senior executives and scientists. SciSparc’s focus is on creating and enhancing a portfolio of technologies and assets based on cannabinoid pharmaceuticals. With this focus, the Company is currently engaged in the following drug development programs based on THC and/or non-psychoactive cannabidiol: SCI-110 for the treatment of Tourette Syndrome, for the treatment of Alzheimer's disease and agitation; and SCI-210 for the treatment of autism and status epilepticus. The Company also owns a controlling interest in a subsidiary whose business focuses on the sale of hemp seeds’ oil-based products on the Amazon.com Marketplace. About Clearmind Medicine Inc. (Nasdaq: CMND) (FSE: CWY) Clearmind is a clinical-stage psychedelic pharmaceutical biotech company focused on the discovery and development of novel psychedelic-derived therapeutics to solve widespread and underserved health problems, including alcohol use disorder. Its primary objective is to research and develop psychedelic-based compounds and attempt to commercialize them as regulated medicines, foods or supplements. Clearmind’s intellectual portfolio currently consists of 19 patent families including 31 granted patents. For further information visit: https://www.clearmindmedicine.com Forward-Looking Statements: This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws. For example, the Company is using forward looking statements when discussing ongoing collaborative research, the prospective outcomes and effects of SciSparc’s collaborative research with Clearmind, and the belief that SciSparc’s approach to its research may improve treatment outcomes. Since such statements deal with future events and are based on SciSparc’s current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of SciSparc could differ materially from those described in or implied by the statements in this press release. The forward-looking statements contained or implied in this press release are subject to other risks and uncertainties, including those discussed under the heading "Risk Factors" in SciSparc's Annual Report on Form 20-F filed with the SEC on April 1, 2024, and in subsequent filings with the U.S. Securities and Exchange Commission. Except as otherwise required by law, SciSparc disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date they were made, whether as a result of new information, future events or circumstances or otherwise. Investor Contact:IR@scisparc.comTel: +972-3-6167055

Patent Expiration

03 Feb 2025

·www.biopharmadive.com

Shares of psychedelics biotech nearly double on depression data

In a little more than a weeks time, a drug developed by a small psychedelics company was able to significantly curb hard-to-treat depression in a mid-stage clinical trial.Thats according to high-level results announced Monday. The trial recruited 81 people with treatment-resistant depression and evaluated them via a widely used, 60-point scale where larger scores mean more severe depressive symptoms. The drug, from Ireland-based GH Research, hit the studys main goal by showing that participants taking it had their scores drop 15.5 points more than those who were given a placebo.GH Research said its drug was well-tolerated. No serious adverse events had been reported as of Jan. 22. All treatment-emergent adverse events were mild or moderate, and investigators found no evidence the drug led to flashbacks, suicidal thoughts or behavior, or changes in heart activity. Almost all participants were discharge-ready within an hour of getting their last doses.Additionally, GH Research called the drug ultra-rapid, providing relief just eight days into treatment. By that time, 58% of patients in the drug arm were in remission, compared with 0% in the placebo group. Among 54 patients who then completed an extension portion of the study in which everyone knowingly got the drug the remission rate was 78% at the six-month mark.A novel treatment with such a large and rapid effect, particularly one that may require only infrequent, short 1-3 hours clinic visits, has the potential to be a practice changing treatment, Michael Thase, a psychiatry professor at University of Pennsylvania and a GH Research scientific adviser, said in a statement from the company.The drug is an inhalable form of mebufotenin, one member in a diverse family of molecules that also includes serotonin, melatonin and a psychedelic chemical found in some mushrooms. GH Research studied it in bipolar II disorder as well, and has a different, injectable version of it that went through a small trial of healthy volunteers.The newly released results look highly compelling and the best-in-class for a psychedelic targeting treatment-resistant depression, according to Paul Matteis, an analyst at the investment bank Stifel. While the experiment was not large, and the lack of any signal in the placebo group could be from patients deciphering what arm they were assigned to, Matteis still thinks the study was well run and had no oddities or red flags.Overall, the data look remarkably consistent and are essentially a best-case scenario for GH Research, he wrote in a note to clients.Shares of GH Research nearly doubled on the news. By late Monday morning they were up 81%, trading at over $19 apiece.Biotechnology investors have viewed psychedelics, much like the broader neuroscience field, as a high-risk, high-reward area of medical research. Theres mounting evidence these drugs can be valuable therapies for common conditions like depression, anxiety and addiction.Last year, psychedelics developers Lykos Therapeutics and Reunion Neuroscience each closed fundraising rounds worth more than $100 million.The hope is that these investments lead to products like Johnson & Johnsons Spravato, a form of ketamine used in treatment-resistant depression as well as certain cases of major depression. Sales from Spravato last year totaled almost $1.1 billion. (Matteis, notably, said his team was struck that GH Researchs drug looks much better than Spravato monotherapy in treatment-resistant depression, where the latter therapy showed a roughly 7-point decline in depressive symptoms after 28 days.)Still, the journey to market remains perilous. Psychedelics trials are exceedingly difficult, in part because the mind-altering effects of these drugs can tip off participants to the therapy theyve received, possibly skewing results.This was a key issue for the Food and Drug Administration when it reviewed a request from Lykos to approve MDMA better known to some as the party drug ecstasy for the treatment of post-traumatic stress disorder.The FDA went on to reject Lykos application, leading the company to lay off about three quarters of its employees. '

Clinical ResultClinical Study

100 Deals associated with Methylenedioxymetamfetamine

External Link

KEGG	Wiki	ATC	Drug Bank
-	Methylenedioxymetamfetamine	-	DB01454

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Stress Disorders, Post-Traumatic	NDA/BLA	US	Lykos Therapeutics, Inc.Startup	13 Dec 2023
Anorexia Nervosa	Phase 2	-	Lykos Therapeutics, Inc.Startup	01 Feb 2026
Binge-Eating Disorder	Phase 2	-	Lykos Therapeutics, Inc.Startup	01 Feb 2026
Alcoholism	Phase 2	-	Awakn Life Sciences, Inc.	05 May 2022
Anxiety Disorders	Phase 2	US	Lykos Therapeutics, Inc.Startup	14 May 2015
Autistic Disorder	Phase 2	US	Lykos Therapeutics, Inc.Startup	11 Apr 2014
Liver Injury	Phase 1	US	Lykos Therapeutics, Inc.Startup	29 Mar 2026
Hyperexplexia Hereditary	Phase 1	US	Lykos Therapeutics, Inc.Startup	14 Mar 2017
Depressive Disorder	Preclinical	CA	Revive Therapeutics Ltd.	03 Feb 2023
Depressive Disorder	Preclinical	CA	PharmaTher Holdings Ltd.	03 Feb 2023

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04030169 (CTgov)	Phase 2	Stress Disorders, Post-Traumatic	21	Midomafetamine HCl	wevsebnroa(nmptlthvaq) = vstrjyznjd zysmhhwcut (osjixbyqwk, lzjpgzfrtm - oaqaqnqtsz) View more	-	28 Jan 2025
NCT04714359 (MAPPUSX, CTgov)	Phase 3	Stress Disorders, Post-Traumatic	87	Midomafetamine HCl	svzinuepgy(gejtydryvw) = ripicpyhbs vpxzmrstkg (hrogfbdrip, daklmulcox - ksrvxcerqv) View more	-	29 Nov 2024
NCT03790618 (ESP, CTgov)	Phase 1	-	36	3,4-Methylenedioxymethamphetamine+methamphetamine (Placebo)	htagvmeafn(fwvicarrlv) = bpxtxpmctc ktmvcmxasi (xvuookgcdk, opljjfixrq - cbkextfamq) View more	-	05 Jan 2024
NCT03790618 (ESP, CTgov)	Phase 1	-	36	3,4-Methylenedioxymethamphetamine+methamphetamine (Low Dose MDMA)	htagvmeafn(fwvicarrlv) = byhrhghpou ktmvcmxasi (xvuookgcdk, zcvafxcdod - ixdlyuglzu) View more	-	05 Jan 2024
NCT04077437 (MAPP2, CTgov)	Phase 3	Stress Disorders, Post-Traumatic	121	Therapy+Midomafetamine (Experimental: MDMA-assisted Psychotherapy)	papdmnucjr(varopmgavj) = vbhngabiba hftclgvdro (abpllwduyp, nfncnezwzl - qhwyvifmem) View more	-	11 Oct 2023
NCT04077437 (MAPP2, CTgov)	Phase 3	Stress Disorders, Post-Traumatic	121	Placebo (Placebo Comparator: Placebo)	edzfgzlaqq(vkbfaefezd) = dcgbrfgggm qkzvfnwafw (xlpovllzju, lowtruftkk - ztxoyybyhw)	-	11 Oct 2023
OR17-01 (ENDO2023)	Not Applicable	Diabetes Insipidus, Neurogenic oxytocin	30	MDMA (Ecstasy)	upcxdxhjte(dwlufclnsk) = oyfummpxom awktwytyhh (eyoydrkjlp, 3 - 17) View more	Positive	05 Oct 2023
OR17-01 (ENDO2023)	Not Applicable	Diabetes Insipidus, Neurogenic oxytocin	30	Placebo	upcxdxhjte(dwlufclnsk) = rxdsarixkb awktwytyhh (eyoydrkjlp, 0 - 2) View more	Positive	05 Oct 2023
IEC2023	Not Applicable	EEG activity	-	MDMA (Non-substance users)	biefxbqpcr(zcqtrzvvyr) = hqywrxblef xlpkmgrqno (mnxgcvunio, +/ - 1.5)	Negative	04 Sep 2023
NCT01211405 (CTgov)	Phase 2	Stress Disorders, Post-Traumatic	26	MDMA (Low Dose MDMA (30 mg))	oerljaspwg(cxclbpfyll) = bdkhodascu tnafavagzb (icykdsgojn, cxljccbymk - zztedcrwnu) View more	-	02 Feb 2022
NCT01211405 (CTgov)	Phase 2	Stress Disorders, Post-Traumatic	26	MDMA (Medium Dose MDMA (75 mg))	oerljaspwg(cxclbpfyll) = royetaodiz tnafavagzb (icykdsgojn, tkbuxpkmhi - zquicejycx) View more	-	02 Feb 2022
NCT01458327 (CTgov)	Phase 2	Stress Disorders, Post-Traumatic	3	3,4-methylenedoxymethamphetamine (MDMA)	zanzourggg(mkgxsyyfwr) = bgbwyhentl tumtumfpsu (lsendhyzli, nyjxtkbzse - ojclpxisxw) View more	-	03 Nov 2021
NCT00090064 (CTgov)	Phase 2	Stress Disorders, Post-Traumatic	23	Lactose placebo pill	zqvjkdwthe(frzwlwxjni) = tglhornlgx kgyteudpuc (nmrrqiqxyx, exrnpezdob - tendtyzlsj) View more	-	25 Oct 2021

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