A new report has been released by Canada’s Senate Subcommittee on Veterans Affairs – ‘The Time Is Now: Granting Equitable Access to Psychedelic Assisted Therapies’ – which recommends the launch of a large-scale research programme on psychedelics for Veterans’ mental health.

Emphasising that around 10 to 15% of Canadian veterans are diagnosed with post-traumatic stress disorder (PTSD), the report explores the opportunity presented by psychedelic research as a treatment for alleviating symptoms of the condition.

The Subcommittee suggests the programme should be funded by Veterans Affairs Canada (VAC) and the Department of National Defence (DND) in partnership with Health Canada, the Canadian Institutes of Health Research, and other relevant partners.

The report states: “This approach would ensure, first of all, that those veterans most likely to benefit from it are given access to treatment with the best scientific support available, and second of all, that the initial findings on the effectiveness of this treatment for veterans are either proven or qualified.”

And goes on to say: “It is the Government of Canada’s duty to assure veterans that it is doing everything in its power, immediately, to respect its solemn commitment to support, at any cost, those who chose to defend us with honour.”

Psilocybin and MDMA have already been added to Canada’s Special Access Program (SAP) which enables authorised patients to access psilocybin and MDMA-assisted therapy for conditions such as PTSD and end-of-life anxiety. 

Studies are showing that both psilocybin-assisted therapy and MDMA-assisted therapy could be potentially efficacious treatments for alleviating symptoms of PTSD in Veterans.

However, the report notes that most clinical studies involve the general population and that Veterans often respond differently to treatments, highlighting the need for further research in the Veteran population.

The report and recommendation have been welcomed by the Psychedelic Association of Canada (PAC), which works with lawmakers, healthcare workers, educators and researchers, psychedelic practitioners, businesses and the public to gain access to psychedelic medicines for Canadians.

Jay Katz, Executive Director of the Psychedelic Association of Canada, stated: “The PAC is encouraged by the contents of the Senate Subcommittee’s report. Their acknowledgement of the potential inherent in reshaping our approach to treating mental illness is an auspicious first step. It paves the way for significantly improved outcomes.”

The organisation has highlighted that, in light of growing research, Canadian citizens have demonstrated strong support for increased access to psychedelic medicines.

To read the full report please visit: sencanada.ca/en/info-page/parl-44-1/veac-psychedelic-therapies/

Psychedelic therapy company Sunstone Therapies has announced the start of its first study investigating multiple doses of psilocybin in the treatment of major depression disorder (MDD) in patients with cancer. 

The Phase 2 two-part study, taking place at the Bill Richards Center for Healing at the Aquilino Cancer Center, will examine the safety and efficacy of up to two 25mg doses of psilocybin in 56 patients administered at an interval of 9 to 10 weeks.

The first part of the study will administer a first dose of psilocybin in a double-blind, randomized, placebo-controlled portion, while the second part of the study will take the form of an open-label portion for patients who do not achieve MDD symptom remission after the first dose.

All study participants will be supported through the first dosing sessions by a study therapist in addition to a second therapist monitoring via video feed, and in the second session, all eligible participants will receive psilocybin 25 mg in an open-label fashion using a group session model.

Chief Medical Officer at Sunstone Therapies and Principal Investigator on the study, Paul Thambi MD, commented: “The emotional distress associated with cancer is often as significant as the physical effects, and yet oncologists have few effective treatments to tackle this important aspect of the patient experience. 

“More recently, the use of psychedelic-assisted therapy has seen renewed interest and a number of studies show a positive impact on symptoms of depression in patients with cancer, including our own open label study published in JAMA Oncology. 

“This new study includes a placebo control arm, the use of group administration, and – for the first time – multiple doses. We believe this adds significantly to the understanding of the role psilocybin-assisted therapy could play in improving patients’ lives and how it might best be delivered.”

Chief Executive Officer at Sunstone Therapies, and Clinical Investigator on the study, Manish Agrawal MD, added: “The Sunstone team has a longstanding commitment to advancing clinical research in psychedelic-assisted therapy in cancer patients, and unique depth of experience across psychedelic modalities and indications. 

“This study builds on our pioneering approach to clinical trial design: there is limited data addressing the question of whether multiple administrations of treatment doses of psilocybin in patients with cancer lead to improved efficacy. 

“We look forward to making a further contribution to the clinical development of this potentially vitally important treatment modality.”

The primary efficacy endpoint of the study is the change in the Montgomery-Asberg Depression Rating Scale (MADRS) from baseline to week 8, and secondary endpoints – which include the onset and durability of response, response rate and remission, and the effect on pain – will be used to assess parameters in both the placebo-controlled and open label study conditions.

Johns Hopkins University School of Medicine (JHU) and Clearmind Medicine will be collaborating on research to investigate the use of a novel psychoactive molecule to treat Alcohol Use Disorder (AUD).

Clearmind has entered into a Clinical Trial Agreement with JHU to conduct its Phase 1/2a clinical trial of its proprietary MEAI-based CMND-100 – a novel psychoactive molecule.

According to Clearmind, CMND-100  has been reported to reduce the desire to consume alcohol while exerting a euphoric alcohol-like experience, and has been found to interact with the serotonergic receptors 5-HT1a, 5-HT2a and 5-HT2b. 

On its website, the company states: “The serotonergic system is considered to play a key role in the regulation of alcohol intake, reward, preference, and dependence. MEAI was also found to interact with the alpha-2-adrenergic receptors α2A, α2B and α2C and the plasma membrane monoamine transporters for dopamine (DAT), norepinephrine (NET) and serotonin (SERT); these are believed to participate in mediating alcohol drinking behaviour, and therefore could constitute important molecular targets for interventions that target drugs of abuse such as alcohol.”

This CM-CMND-001 clinical trial will be a multinational, multi-center, Phase I/II single- and multiple-dose tolerability, safety and pharmacokinetic study in healthy volunteers and AUD subjects.

Clearmind CEO, Dr Adi Zuloff-Shani, stated: ”We are honoured to collaborate with JHU for our first in-human clinical trial. JHU is one of the global leaders in psychedelics clinical research and in researching addictions, and we are very grateful to partner with them to study our proprietary CMND-100 to treat Alcohol Use Disorder.

“Johns Hopkins is our second US clinical site joining our trial, following Yale School of Medicine’s Department of Psychiatry. 

“We are excited to be working closely with two of the world’s leading medical centres, who have researched our treatment and agreed to participate in our clinical programme.”

The primary end point of the trial is to find the tolerable dose and characterise the safety and pharmacokinetics/pharmacodynamics (PK/PD) of single and repeated doses of CMND-100 in healthy subjects and those with Alcohol Use Disorder. 

The secondary end point is to evaluate the efficacy of CMND-100 in reduction of drinking patterns and cravings, in individuals with moderate-to-severe AUD. Oral capsules will be administered once daily, for ten consecutive days. The patients will report their drinking patterns and craving for alcohol (and cigarettes) during the clinical trial period.

The principal investigator, Jennifer Ellis, PhD, Associate Professor of Psychiatry and Behavioral Sciences, JHU School of Medicine will be supported by co-investigators Professor Eric Strain, Director, Behavioral Pharmacology Research Unit, JHU School of Medicine.