There is increasing interest in the use of psychedelic drugs for the treatment of mental health conditions, such as depression, post-traumatic stress disorder (PTSD), substance use disorders and end-of-life distress. Psychedelic drugs can produce altered states of consciousness lasting for hours. It is still unclear how psychedelics work to treat mental health conditions. However, research studies have indicated that psychedelic drugs may increase neuroplasticity, helping to rewire connections between brain cells and creating an opportunity to change thought and behavioural patterns.
In psychedelic-assisted therapy, patients use psychedelic drugs combined with psychotherapy under the supervision of a trained practitioner. Generally, the therapy extends over multiple visits, with sessions before, during and after drug use. If effective, psychedelic-assisted therapy could address an unmet need for treating mental health conditions that do not respond to standard therapies. In Canada, an estimated one in five people are affected by a mental illness each year. Over 20% of major depression cases are treatment resistant.
The legal status of psychedelics is a barrier to their use in research and medicine. In Canada, federal law has criminalized most psychedelic drugs since the 1970s, although exemptions for medical and research purposes may be granted. Some Canadian physicians and advocacy groups seek expanded access to these drugs. Internationally, certain jurisdictions have made legislative or regulatory changes addressing the use of psychedelic drugs, including Australia and several American cities and states.
This HillNote explores key issues surrounding psychedelic-assisted therapy, as summarized in Figure 1.
Figure 1 – Key Considerations for Psychedelic-Assisted Therapy in Canada
Source: Figure prepared by the Library of Parliament.
Research Landscape
Researchers have studied the therapeutic use of psychedelics for a range of mental health conditions, although the volume and quality of the scientific evidence vary by condition and by drug.
Psychedelic drugs include substances such as the following:
- psilocybin and psilocin (active ingredients in magic mushrooms);
- 3,4-methylenedioxymethamphetamine (MDMA, ecstasy);
- ketamine;
- lysergic acid diethylamide (LSD);
- N, N-dimethyltryptamine (DMT);
- mescaline;
- ayahuasca; and
- peyote.
Advanced (phase III) clinical trials are underway examining the use of the following:
- psilocybin for treatment-resistant depression;
- MDMA for PTSD; and
- ketamine for alcohol use disorder.
Certain psychedelic therapies have been granted “breakthrough therapy” designation by the United States Food and Drug Administration to expedite their development and regulatory review, including MDMA for PTSD in 2017 and psilocybin for treatment-resistant depression and major depressive disorder in 2018 and 2019, respectively.
Federal Research Funding
In 2022, the Canadian Institutes of Health Research launched a research grant on psilocybin-assisted psychotherapy. The grant has funded three trials examining the clinical benefit of psilocybin for end-of-life distress, alcohol use disorder and treatment-resistant depression.
Legal Landscape
Controlled Drugs and Substances Act
With limited exceptions, psychedelics are illegal in Canada under the Controlled Drugs and Substances Act (CDSA). Exemptions may be made via section 56 to allow for controlled use in scientific research and medicine. The first CDSA exemptions for psychedelic therapy were granted by the federal Minister of Health in August 2020, permitting four patients with end-of-life distress to use psilocybin.
The prohibition of psilocybin-assisted therapy has been challenged a number of times in court. In 2022, a Federal Court challenge was brought by eight patients on the basis that the prohibition violates the right to life, liberty and security of the person protected by section 7 of the Canadian Charter of Rights and Freedoms.
Special Access Program
In January 2022, amendments to the Food and Drug Regulations have made it possible to request restricted drugs through Health Canada’s Special Access Program (SAP). Under the SAP, healthcare professionals and researchers can apply for permission from Health Canada to access psychedelics for use in clinical trials and to treat patients. To conduct activities legally with restricted drugs, appropriate authorization under both the Food and Drugs Act and the CDSA is required. Health Canada’s class exemption for psilocybin and MDMA removed the need for individual section 56 exemptions for these SAP requests.
Health Canada Licensing
Ketamine is licensed by Health Canada for use as an anesthetic.
In 2020, Health Canada authorized esketamine (a form of ketamine) nasal spray for treatment-resistant depression. It is available only through a controlled distribution program.
International Treaties
Canada is a signatory to three international drug control conventions negotiated under the auspices of the United Nations, with a reservation to the Convention on Psychotropic Substances, 1971 regarding the use of peyote for ceremonial or religious purposes.
Provincial and Territorial Initiatives
Alberta became the first province to provide regulatory guidelines for the use of psychedelic-assisted therapy in October 2022. In December of that year, Quebec became the first province to publicly fund psilocybin-assisted psychotherapy. Health Canada approval is still required on a case-by-case basis.
Regulation and Licensing of Service Providers
Psychedelic-assisted therapy is typically given under the supervision of a trained practitioner. There is currently no consensus on the type of training, licensing or codes of conduct required for such practitioners. However, a committee of Canadian scholars has made recommendations in this area, notably the creation of a national advisory council and a credentialling council. Additionally, Alberta has implemented a framework for the regulation and licensing of psychedelic drug treatment service providers.
Respectful Engagement with Indigenous Communities
The use of psychedelic drugs in Indigenous communities is a complex topic, and a full discussion is beyond the scope of this HillNote.
Certain Indigenous populations around the world have used plants with psychoactive properties, such as peyote and ayahuasca, in ceremonial and religious contexts. Peyote is specifically excluded from the CDSA, despite containing mescaline.
Concerns exist surrounding the cultural appropriation of ancestral traditions, the commodification of traditional practices, a lack of engagement with Indigenous communities and fundamental differences between Western science and Indigenous ways of knowing.
Given limitations in the availability of some plants, supply management is another concern with the expansion of psychedelic-assisted therapy. Article 24.1 of the United Nations Declaration on the Rights of Indigenous Peoples states that “Indigenous peoples have the right to their traditional medicines and to maintain their health practices, including the conservation of their vital medicinal plants.”
Patient Vulnerability and Safety
Patients, especially women, can become more vulnerable to violence or abuse during psychedelic-assisted therapy due to the altered state of consciousness induced by the drugs. In December 2022, Health Canada released a notice regarding risk management measures for clinical trials of psychedelic-assisted therapy.
Equity in Access
Lack of diversity among study participants is a concern regarding clinical trials of psychedelic-assisted therapy. Most participants to date have been white, resulting in a gap in evidence for different races or ethnicities.
The time-intensive and supervised nature of psychedelic-assisted therapy could make it costly. High costs could pose a barrier for people with limited incomes or without health insurance.
According to a 2021 paper, individuals and communities with the greatest need for psychedelic-assisted therapies may face the most barriers to accessing them due to structural inequities. Therefore, the authors recommended an equity-informed approach incorporating trauma-informed and culturally safe care in the implementation of psychedelic-assisted therapies.
Parliamentary Activities
The February 2023 report of the Special Joint Committee on Medical Assistance in Dying noted potential barriers or inefficiencies in the regulatory processes preventing those with end-of-life distress from accessing psychedelics such as psilocybin. The committee recommended a review of the SAP and other relevant programs, policies, laws and regulations to improve access in the context of palliative care.
In a November 2023 report, the Senate Subcommittee on Veterans Affairs recommended that federal, provincial and territorial governments launch and fund a large-scale research program on psychedelic-assisted therapy to determine its potential therapeutic benefit for veterans diagnosed with mental health conditions such as PTSD.
By Kelly Farrah, Library of Parliament
Categories: Health and safety, Social affairs and population