Revive Therapeutics has enrolled the first patient into its Phase I/II trial investigating the safety and feasibility of oral psilocybin to treat methamphetamine use disorder (MUD).

The open-label trial (NCT05322954) is planning to enrol 12 participants with MUD and topline data is expected in Q3 2023.

After the physical and psychological screening, eligible participants will receive at least six hours of psychological support before ingesting one oral dose of psilocybin, a naturally occurring hallucinogenic chemical found in certain mushrooms known as magic mushrooms.

The study will follow the usual trial design for psychedelic research, with two trained facilitators observing the session. After eight hours of observation, participants will spend the night at the hospital’s clinical research unit and complete an integration session before being discharged. After four weeks, participants will receive a second oral dose.

The trial is sponsored by the University of Wisconsin-Madison, US.

The primary endpoint will measure serious adverse events associated with oral psilocybin while one of the secondary endpoints will investigate the frequency of use of methamphetamine and other substances.

As previously reported by Clinical Trials Arena, the stigma around substance use disorders is suspending the development of new medications. This field has been neglected by the pharma industry with most ongoing or planned clinical trials conducted by academic institutions. Questionable profitability and inherently complex trial design are a few of the reasons why the commercial sector is not investing more in trials researching addiction.

In a press release, Revive noted that the data generated from the trial might provide valuable information on psilocybin to support research and commercial initiatives in countries such as Australia, where licensed psychiatrists will be able to prescribe psilocybin and 3,4-Methyl​enedioxy​methamphetamine (MDMA) for certain indications.

In the past few years, psychedelic research has hit the headlines and coverage from the mainstream media is fuelling high expectations on how effective these therapies are. Experts told Clinical Trials Arena that the research field is still in its infancy, with certain study execution challenges in sight.

However, regulatory bodies are taking the first initial steps to provide guidance on how these studies should run. In this year’s planned draft guidance agenda, FDA’s Center for Drug Evaluation and Research (CDER) added a new item called ‘Psychedelic Drugs: Considerations for Scientific Investigations’. While Health Canada released a notice last year, the FDA’s document is likely to be the first guidance document released by a regulatory agency.

While psychedelic-assisted psychotherapies are most used in psychedelic research, other companies are trying to find new ways. For example, Diamond Therapeutics is planning to run a Phase II trial in anxiety by providing low doses of take-home psilocybin.