Queen’s and KHSC launch clinical trial of psilocybin therapy to treat alcohol use disorder

News & Announcements | 25 Apr 2023

Researchers at Queen’s University and Kingston Health Sciences Centre (KHSC) will soon begin recruiting patients to study the efficacy of psychedelic-assisted therapy for the treatment of alcohol use disorder (AUD). The Phase 2b clinical trial, sponsored by Vancouver-based Clairvoyant Therapeutics, will assess whether motivational enhancement therapy and the use of psilocybin can help those living with the disorder.

Alcohol use disorder is a medical condition characterized by an impaired ability to stop or control alcohol use despite adverse social, occupational, or health consequences. It is more commonly referred to as alcoholism, and it is a significant problem in Canada, both due to short-term and longer-term impacts on Canadians, their families and communities.

“One in five Canadian adults will suffer from alcohol use disorder at one point during their lifetimes, and we still struggle to find the best way to help them with the resources we currently have in the health care system,” said Queen’s psychiatry professor Dr. Claudio Soares, the lead researcher for the study in Kingston and the chair of the Psychedelic Science Advisory Committee for the Dimensions Health Research Collaborative. “As clinicians and researchers, we have a responsibility to stretch the boundaries in the pursuit of new and better ways to treat this medical disorder, and psychedelics are part of the emerging treatment options.”

Psilocybin is a naturally-occurring molecule found in some species of mushrooms that can induce an altered state of consciousness. Although psilocybin has been used both spiritually and recreationally for a long time, in recent years, there has been renewed interest among researchers to study its effectiveness vs. placebos. In particular, a number of researchers are whether offering patients psychotherapy in combination with psilocybin is a safe and effective form of treatment for a range of medical conditions, including depression and AUD.

Beginning this spring, Queen’s researchers will aim to recruit 10 patients from Kingston and surrounding communities, with the clinical trial expected to launch by May 2023. Kingston will join six other sites in Canada and Europe that are already recruiting patients for the clinical trial.

The research will take place over a 24-week period at the Kingston General Hospital Research Institute (KGHRI) located on the grounds of Kingston Health Sciences Centre. Participants will be randomly assigned to two groups – one that will receive a 25mg capsule of psilocybin, and one which will receive a matching Placebo. All patients will receive psychotherapy provided by trained practitioners.

“The opportunity for KHSC to be a clinical site for this study is very exciting as psychedelic- assisted therapy has tremendous potential but requires a critical, evidence-based scientific approach to truly assess the positive impacts and any adverse consequences,” said Dr. Steven Smith, Vice President, Health Sciences Research at KHSC and President and CEO of the Kingston General Health Research Institute (KGHRI). “This study is another example of the outstanding collaborative research eco-system involving KHSC, the KGHRI, and Queen’s University. We look forward to making significant research contributions in psychedelic medicine.”

The study sponsor, Clairvoyant Therapeutics, is a Canadian biotechnology company with a stated goal of, “trailblazing a path to global mental health through psilocybin therapy.” Its strategy is designed to enable psilocybin therapy in the EU, UK & Canada to treat patients living with Alcohol Use Disorder (AUD) beginning in 2026.

“The Clairvoyant team is excited to have Queen’s University and KHSC as a key clinical site for our psilocybin AUD trial,” said Damian Kettlewell, CEO of Clairvoyant. “Recently reported data from a related psilocybin trial for AUD has demonstrated a significant response to treatment. Our goal is to build on this research in Clairvoyant’s Phase 2 randomized controlled trial which we hope will support clinical approval of psilocybin for the treatment of AUD in Canada and other countries.”

NEXT STEPS

The trial will be open to individuals that have experienced more than six heavy drinking days during the 4 weeks prior to starting the trial. For men, a heavy drinking day is consumption of more than 60g of alcohol (or approximately 4.5 standard drinks). For women, a heavy drinking day is about 3 standard drinks. Alternatively, men who drink an average of at least 3 drinks every day (and women who drink an average of about 1.5 drinks per day) meet the criteria for heavy drinking.

Before being cleared to participate, clinical trial participants will undergo several screening tests to identify their physical, mental, and emotional suitability to take part in the trial. In addition to basic criteria like being between the ages of 18 and 70, participants would need to have a stable residence. Patients with significant health problems such as cardiac disease, uncontrolled hypertension or Type 1 diabetes would be ineligible to take part. In addition, a family history of schizophrenia, bipolar disorder, obsessive compulsive disorder or other psychotic episodes would lead to a patient being screened out of the trial.

To learn more about the study and its eligibility criteria, Kingston and area residents can contact Dr. Soares’s research group via email: Yan.deng@queensu.ca

David Clements, the executive director of the Dimensions Health Research Collaborative, said this clinical trial is an example of the type of research envisioned when then collaborative was established in 2021, with support from the Dimensions Health Fund in support of the Study of Psychedelics, established by Dimensions Health Centres.

“Queen’s University is working hard to build partnerships to help advance global knowledge about whether psychedelic-assisted therapies can offer advantages in the treatment of various health conditions,” said Clements. “Our mission is to support high-quality, well-designed research that could lead to significant breakthroughs.”

Queen’s and KHSC launch clinical trial of psilocybin therapy to treat alcohol use disorder

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