Methamphetamine dependence

MONDAY, June 10, 2024 — Though overdose deaths continue to surge, there is no approved medication to treat methamphetamine use disorder. Now, an experimental two-drug therapy has yielded promising results, UCLA researchers report. "These findings have important implications for pharmacological treatment for methamphetamine use disorder," said researcher Dr. Michael Li , an assistant professor-in-residence of family medicine at the David Geffen School of Medicine at UCLA, adding that methamphetamine-involved overdoses have surged. His team published its findings June 10 in the journal Addiction . In urine tests for methamphetamine, drug-free results rose 27% among participants who received a combination of injectable naltrexone plus extended-release oral buproprion. Negative tests rose only 11%, meanwhile, in a control group. Methamphetamine abuse is a growing problem around the world, with an estimated 34 million users in 2020 compared to 33 million 10 years earlier. In the United States alone, overdose deaths rose fivefold between 2012 and 2018. The National Institute on Drug Abuse Clinical Trials Network has supported various trials, including this one, to evaluate different treatments for methamphetamine use disorder. This trial, known as ADAPT-2, ran from May 2017 to July 2019 at eight sites. More than 400 participants were included, including 109 who received the experimental drug therapy in the first phase. That demonstrated that the combo worked at six weeks. The new findings are from the trial's second phase, which looked at a longer period. Partipants were drug-tested at weeks seven and 12 and again, after treatment, at 13 and 16 weeks. While their results were encouraging, researchers said further study is needed to find out if the treatment lasts longer than 12 weeks and leads to further reductions in drug use. "Prior stimulant use disorder treatment trials suggest that change in use is gradual [consistent with our findings], unlikely to result in sustained abstinence in a typical 12-week trial, and dependent on treatment duration," the researchers said in a UCLA news release. "This warrants future clinical trials to quantify changes in [methamphetamine] use beyond 12 weeks and to identify the optimal duration of treatment with this medication." Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

A clinical trial on a two-drug therapy for methamphetamine use disorder reduced use of the highly addictive drug for up to 12 weeks after initiation of treatment. Participants in the ADAPT-2 clinical trial who received a combination of injectable naltrexone plus extended-release oral bupropion (NTX+BUPN) had a 27% increase in methamphetamine-negative urine tests, indicating reduced usage. By contrast, the placebo group had an 11% increase in negative tests. To date there is no FDA-approved medication for it. A clinical trial on a two-drug therapy for methamphetamine use disorder reduced use of the highly addictive drug for up to 12 weeks after initiation of treatment, UCLA-led research suggests. Participants in the ADAPT-2 clinical trial who received a combination of injectable naltrexone plus extended-release oral bupropion (NTX+BUPN) had a 27% increase in methamphetamine-negative urine tests, indicating reduced usage. By contrast, the placebo group had an 11% increase in negative tests. The study will be published in the peer-reviewed journal Addiction. "These findings have important implications for pharmacological treatment for methamphetamine use disorder. There is no FDA-approved medication for it, yet methamphetamine-involved overdoses have greatly increased over the past decade," said Dr. Michael Li, assistant professor-in-residence of family medicine at the David Geffen School of Medicine at UCLA and the study's lead author. Methamphetamine use has continued growing over the years around the world, increasing from 33 million people in 2010 to 34 million in 2020. Overdose deaths from the drug have jumped fivefold in the US from 2012 to 2018, and are followed by Canada and Australia in increases. To curb the ongoing crisis, the National Institute on Drug Abuse (NIDA) Clinical Trials Network has supported various trials, including the ADAPT-2 trial, to test the effects of different pharmacological treatments for methamphetamine use disorder. ADAPT-2 was carried out from May 23, 2017 to July 25, 2019 across the eight trial sites that included UCLA. It included 403 participants, with 109 assigned to the drug combo group and the rest to the placebo group in the first stage. The latest findings are the second stage of the multi-site trial. The earlier stage had demonstrated that the two-drug combination worked at six weeks, but the unanswered question was whether the intervention remained efficacious over a longer period. In the second stage, the researchers conducted urine tests on the participants at weeks seven and 12, and again post-treatment at weeks 13 and 16 comparing the group on NTX+BUPN with the placebo group. There is a need for further research to determine whether the drug treatment effect lasts longer than 12 weeks and yields further methamphetamine use reductions, the researchers write. "Prior stimulant use disorder treatment trials suggest that change in use is gradual (consistent with our findings), unlikely to result in sustained abstinence in a typical 12-week trial, and dependent on treatment duration," they write. "This warrants future clinical trials to quantify changes in MA use beyond 12 weeks and to identify the optimal duration of treatment with this medication." Study co-authors are Brendon Chau, Thomas Belin, and Steven Shoptaw of UCLA, and Thomas Carmody, Manish Jha, Elise Marino, and Dr. Madhukar Trivedi of the University of Texas. The study was funded by awards from the National Institute on Drug Abuse of the U.S. National Institutes of Health (UG1DA020024, K01DA051329, UG1DA013035, UG1DA040316, UG1DA013727, and UG1DA015815), the U.S. Department of Health and Human Services under contract numbers HHSN271201500065C (Clinical Coordinating Center, the Emmes Company) and HHSN271201400028C (Data and Statistics Center, the Emmes Company), the U.S. National Institute of Mental Health (K23MH126202) and the O'Donnell Clinical Neuroscience Scholar Award from the University of Texas, Southwestern Medical Center.

VANCOUVER, British Columbia, April 09, 2024 (GLOBE NEWSWIRE) -- Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FRA: 8BN), a leading Health Canada licensed psychedelics pharmaceutical manufacturer, specializing in controlled substances such as natural psilocybin and MDMA, is proud to announce the signing of an international natural psilocybin supply agreement with New Zealand-Based Mātai Medical Research Institute (Mātai), on behalf of the Tū Wairua Project. This agreement marks Optimi's first supply deal to New Zealand, a significant milestone for the company's global expansion efforts. Under the terms of the agreement, Optimi will provide Mātai with a quantity of its validated GMP Full Spectrum Natural Psilocybin extract. Further, the agreement includes tracked stability of the extract, ensuring the highest standards of GMP quality and compliance. This follows Optimi's recent announcement that three validation batches of its Natural Psilocybin extract had successfully undergone full release testing, resulting in the issuance of the Certificate of Analysis (COA). In November 2023, the Tū Wairua project, a collaborative effort involving a diverse array of individuals, whānau (families), community groups, and institutions, convened at Rangiwaho Marae, a tribal meeting place in the Tairāwhiti region of New Zealand. The project team has since designed a clinical trial protocol and secured ethics and regulatory approval for its inaugural clinical study. Scheduled for mid-2024, the trial, titled "Pilot Study of Psilocybin Administration in Healthy Volunteers within a Marae Setting," aims to evaluate the feasibility, acceptability, and safety of administering psychedelic-assisted therapy to Māori patients in a marae setting. The insights gained from this trial will inform potential future controlled trials involving Māori patients with methamphetamine use disorder. Bill Ciprick, CEO of Optimi Health, expressed his enthusiasm about the agreement, stating, "We are excited to collaborate with Mātai and the Tū Wairua team on this groundbreaking venture. This agreement marks our entry into a new market and underscores the historical and cultural importance of the work being undertaken by our colleagues in New Zealand to honour and respect the indigenous heritage of the Māori people. This project holds special significance for Optimi, and we are honoured to be part of it." Dr Patrick McHugh, Community Liaison for Mātai, confirms that the trial will centre on training local clinicians, rongoa (traditional Māori medicine) specialists and marae community members as kaitieki (guides) in psychedelic assisted therapy. Additionally, it will involve integrating the associated kawa and tikanga (cultural practices and protocols) into the therapeutic experience, making this the first trial of its kind in Aotearoa. “We recognise that, alongside many First Nations peoples, we have a relationship with native flora and fauna as a source of healing and reconnection to our respective indigenous cultural practices,” says Jody Toroa, trustee of Rangiwaho Marae. "Optimi medicines provide the closest natural fungi to the marae’s local, indigenous species, which for Rangiwaho Marae and the Tū Wairua collective, is key to the integrity of the project. Synthetic products, by comparison, are not conducive to our reclaiming of cultural knowledge and customary practice,” says Jody. In New Zealand, any registered prescriber can apply through the New Zealand Medicines and Medical Devices Safety Authority (Medsafe) for permission to administer an unapproved medicine. As the only fully equipped Canadian psychedelics pharmaceutical manufacturer, Optimi is well-positioned to meet large-scale demand for GMP psilocybin and MDMA drug products through its 10,000 sq ft cultivation and formulation facility. For media inquiries, please contact Michael Kydd: michaelk@optimihealth.ca 902.880.6121 For investor inquiries, please contact: investors@optimihealth.ca www.optimihealth.ca ABOUT OPTIMI (CSE: OPTI) (OTCQX: OPTHF) (FRA: 8BN) Optimi Health Corp. IS a leading Health Canada licensed psychedelics pharmaceutical manufacturer specializing in controlled substances such as GMP-grade natural psilocybin and MDMA for clinical research purposes and patient access programs, as well as functional mushrooms that focus on the health and wellness markets. Built with the purpose of producing scalable psychedelic formulations for transformational human experiences, the Company’s goal is to be the number one trusted, compassionate supplier of safe and compliant GMP drug candidates throughout the world. Optimi’s products are grown and manufactured at its two facilities comprising a total of 20,000 square feet in Princeton, British Columbia. ABOUT MATAI MEDICAL RESEARCH INSTITUTE: Established in October 2020, Mātai is a distinguished not-for-profit research and innovation center located in Gisborne Tairāwhiti, New Zealand. Renowned for its cutting-edge medical imaging facilities, including a state-of-the-art GE 3-Tesla MRI machine and a team of expert researchers, Matai is at the forefront of medical innovation. ABOUT KAUPAPA TŪ WAIRUA: The project is an evolving collaboration between a diverse group of individuals, whānau, community groups and institutions. Organisations involved include: Rangiwaho MaraeRua BioscienceESRManaaki Whenua Landcare ResearchUniversity of AucklandUniversity of WaikatoMātai Medical Research InstituteTūranga HealthIo Limited FORWARD‐LOOKING STATEMENTS This news release contains forward-looking statements and forward-looking information within the meaning of Canadian securities legislation (collectively, “forward-looking statements”) that relate to Optimi’s current expectations and views of future events. Any statements that express, or involve discussions as to, expectations, beliefs, plans, objectives, assumptions or future events or performance (often, but not always, through the use of words or phrases such as “will likely result,” “are expected to,” “expects,” “will continue,” “is anticipated,” “anticipates,” “believes,” “estimated,” “intends,” “plans,” “forecast,” “projection,” “strategy,” “objective,” and “outlook”) are not historical facts and may be forward-looking statements and may involve estimates, assumptions and uncertainties which could cause actual results or outcomes to differ materially from those expressed in such forward-looking statements. forward-looking statements made in this news release include the proposed use of the proceeds of the Offering. No assurance can be given that these expectations will prove to be correct and such forward-looking statements included in this news release should not be unduly relied upon. These statements speak only as of the date of this news release. Forward-looking statements are based on a number of assumptions and are subject to a number of risks and uncertainties, many of which are beyond Optimi’s control, which could cause actual results and events to differ materially from those that are disclosed in or implied by such forward-looking statements. Optimi undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law. New factors emerge from time to time, and it is not possible for Optimi to predict all of them or assess the impact of each such factor or the extent to which any factor, or combination of factors, may cause results to differ materially from those contained in any forward-looking statement. Any forward-looking statements contained in this news release are expressly qualified in their entirety by this cautionary statement. Neither the Canadian Securities Exchange nor the Investment Industry Regulatory Organization of Canada accepts responsibility for the adequacy or accuracy of this release.