In a news release, Revive Therapeutics Ltd. (RVV:TSX.V; RVVTF:OTCMKTS) announced that it has entered into a Clinical Trial Agreement (CTA) with the University of Wisconsin System's (UWS) Board of Regents. The CTA was signed on August 28, 2020, and was established in order to initiate a clinical study entitled, "Phase I Study of the Safety and Feasibility of Psilocybin in Adults with Methamphetamine Use Disorder."
The company stated that CTA terms provide Revive Therapeutics with "an exclusive option to obtain an exclusive, worldwide, royalty-bearing commercialization license to all rights, title and interest that UWS may have or obtain in any invention that results from the clinical study."
Revive Therapeutics CEO Michael Frank remarked, "We are delighted to be collaborating with clinical researchers at the University of Wisconsin‒Madison to advance development of psilocybin for the potential treatment of methamphetamine use disorder...We are building a pipeline of clinical-stage psychedelic-derived therapies for addiction disorders with a focus on psilocybin with unique dosage forms."
The firm stated that the clinical study will take place at the University of Wisconsin Schools of Medicine and Public Health and Pharmacy which has been granted a Wisconsin special authorization and Drug Enforcement Administration license to carryout psilocybin clinical research.
The company stated that Assistant Professor and clinical psychologist Christopher R. Nicholas, Ph.D., at the University of Wisconsin School of Medicine and Public Health's Program for Research Outreach Therapeutics and Education in the Addictions (PROTEA) in the Department of Family Medicine and Community Health, will serve as principal investigator for the initial safety study. The PROTEA team has already completed significant amounts of research involving the pharmacokinetics of high-dose psilocybin and is now additionally investigating the potential for psilocybin as an opioid use disorder treatment.
The company indicated that methamphetamine use disorder is caused by frequent and recurrent use of methamphetamine and that according to a 2018 National Survey on Drug Use and Health conducted by the Substance Abuse and Mental Health Services Administration, there are around 1.1 million people in the U.S aged 12 or older who have a methamphetamine use disorder. The firm noted that currently there are no approved pharmaceutical treatments approved for methamphetamine dependence. At present, treatment approaches are limited to using behavioral modification therapies, such as cognitive-behavioral therapy to change thinking patterns based upon what a patient is feeling and contingency management interventions employing behavior analysis assessments and techniques.
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