A Public-Health-Based Vision for the Management and Regulation of Psychedelics

This policy article (2016) assesses the harms and benefits of psychedelics use in light of contemporary research and provides a public-health-based model for their regulation, which includes governance, supervision, set and setting controls, youth access, supply control, demand limitation, and evaluation.

Abstract

“The Health Officers Council of British Columbia has proposed post-prohibition regulatory models for currently illegal drugs based on public health principles, and this article continues this work by proposing a model for the regulation and management of psychedelics. This article outlines recent research on psychedelic substances and the key determinants of benefit and harm from their use. It then describes a public-health-based model for the regulation of psychedelics, which includes governance, supervision, set and setting controls, youth access, supply control, demand limitation, and evaluation.”

Authors: Mark Haden, Brian Emerson & Kenneth W. Tupper

Summary

The Health Officers Council of British Columbia has proposed a model for the regulation of psychedelics based on public health principles.

The prohibition of certain psychoactive substances generates harmful unintended consequences, and there is growing interest in alternative approaches to drug control. Psychedelic drugs are one class of substances garnering increased attention among scientists, physicians, spiritual leaders, and the general public.

Many frameworks can be used to understand concerns with the existing prohibitionist approach to psychedelics and to explore alternatives, including religious freedom, human rights, and cognitive liberty.

Public health leaders have called for the development of post-prohibition models of drug control that are organized, comprehensive, multi-sectoral, and directed at maintaining and improving the health of populations.

The Health Officers Council of British Columbia proposed a public health framework for regulating psychoactive substances, which was used to articulate drug-specific, post-prohibition regulatory models for cannabis and smokeable and injectable stimulants.

Summary of current research on psychedelics

A recent study of MDMA-assisted psychotherapy demonstrated positive effects on post-traumatic stress disorder (PTSD) symptoms. Most participants who received MDMA no longer met the DSM-IV criteria for PTSD, and the therapeutic benefits were still evident years after the treatment.

Psilocybin-assisted psychotherapy was associated with reduced anxiety and improved mood among individuals with advanced cancer, and non-clinical use of psychedelics was associated with reduced psychological distress and suicidality, reduced recidivism for offenders under community supervision, and reduced arrests for intimate partner violence.

Early psychedelic research in the 1950s and 1960s yielded intriguing evidence for psychedelic therapies to treat alcohol and opioid addiction. This evidence was supported by a meta-analysis of six historical trials, and an open-label pilot study of psilocybin-assisted treatment for tobacco dependence.

Studies with healthy human participants have shown that psychedelics have positive effects on attitude and behavior, and can affect domains of personality which are usually understood to be stable and fixed in adulthood.

Recent clinical psychedelic research findings should be regarded as preliminary due to the small sample sizes, but no serious or enduring adverse effects were observed when appropriate screening and safeguards were used. Medical researchers have called for increased investigation into the potential benefits of psychedelics for mental illness and addiction treatment.

There was interest in psychedelic-assisted treatments before they were prohibited and criminalized, and some promising research avenues were prematurely terminated and unfulfilled for decades.

Psychedelic drugs were criminalized in the 1960s because of Timothy Leary’s anti-social message and the socio-political context of the 1960s, which included the demographic shifts wrought by the Baby Boom generation and the loosening of sexual mores associated with the advent of the birth control pill.

Set and setting: Determinants of benefits and harms

The prohibition of psychedelics did not eliminate their illegal, uncontrolled, non-medical use, and has generated significant harms. For example, drugs sold as “ecstasy” are often adulterated with other substances, resulting in unpredictable toxic effects.

Many indigenous societies have used psychedelic preparations as sacraments in ancient ritualistic healing and spiritual practices. Early researchers proposed experiments with religious settings for modern psychedelic studies, but their results demonstrated the importance of careful supervision of people during psychedelic experiences.

Psychedelics are relatively safe in indigenous cultural practices, and the use of psychedelics in a peaceful, natural environment surrounded by supportive family, friends, or spiritual community is associated with a reduction of problematic use and associated health and social problems.

Psychedelic drugs have low potential for health or social harms, and are relatively non-toxic and have very low dependence potential. Some health harms are reported in the medical literature, but the incidence is low and are typically associated with illicit substances of unknown purity taken in uncontrolled settings without supervision.

Public health regulatory model

The following model for regulating psychedelic substances is drawn from the lessons learned from the regulation of alcohol and tobacco, although other models are possible and deserve consideration.

Psychoactive Substance Commission (PSC)

We propose establishing a Psychoactive Substance Commission (PSC) to regulate psychedelics, other currently illegal drugs, and potentially also alcohol and tobacco. The PSC would work with religious or cultural groups to oversee the cultivation and importation of plant-based preparations used in specific spiritual/ sacramental traditions.

College of psychedelic supervisors

To ensure the health of the public, a regulatory body would be established to oversee trained and qualified supervisors who manage and support the use of psychedelic substances. This body would develop regulations, performance standards, procedures, guidelines, and accreditation criteria.

Psychedelic supervisors can be certified or licensed. Certification results in a professional designation and the person licensed is subject to oversight by a licensing body.

Certification would allow for easier entrance for psychedelic users/sitters currently practicing outside the law to become supervisors within this new regulatory regime.

Licensure would provide more rigorous training and evaluation, high standards of care, and peer oversight.

We recommend a model which allows for the benefits of both of these approaches, by requiring a basic certification and allowing for optional advanced streams and levels.

Advanced training would build on the basic certification skills and lead to licensure as a psychedelic supervisor. These supervisors could facilitate psychedelic psychotherapy, structure ayahuasca ceremonies, or manage multi-day music festivals.

The College of Psychedelic Supervisors would approve the content and duration of certification and licensure training programs, with input from clinical, academic, and public health experts. It would be important for supervisors who are part of existing traditions for ceremonial/sacramental psychedelic experiences to be part of this process.

Psychedelic supervision could be provided in psychotherapy, indigenous healing circles, dance events, music festivals, palliative care wards, or natural environments. The supervisor would provide appropriate safeguards and create a positive, attractive environment with carefully selected music.

Screening individuals, obtaining informed consent, involving participants in the choice of dosage, communicating the different pharmacological profiles of the psychedelics, preventing the operation of a motor vehicle or machinery while under the influence, managing interactions between participants in group settings, and ensuring the continuous presence of a responsible individual.

Youth access to psychedelics

In some indigenous societies, youth are given access to psychedelic plant preparations as a normal part of community functioning, such as honoring ceremonial rites of passage.

In Canada, youth can access health services without parental approval when they are deemed mature. They are provided detailed information and obtain these services from trained adults.

We propose a model for psychedelic access for youth that borrows from the healthcare access model. Youth would be required to obtain basic certification and would only be able to access psychedelic experiences from adults with a licence to supervise youth.

Supply control

The PSC would control and monitor the production and distribution of psychedelics, and ensure that vulnerable species like peyote, iboga, and potentially ayahuasca are protected, cultivated, harvested, and fairly traded in a way that ensures sustainability of the species.

Only certified or licensed psychedelic supervisors would be able to acquire a range of different psychedelics, and the risk of diversion from legal sources to illegal markets can never be completely controlled.

Demand mitigation

An effective public health approach to regulating psychedelics would take an evidence-based approach to mitigating demand for such substances. This would include bans on activities promoting the commercial sale of psychedelic drugs, and honest health-promotion-oriented psychoactive substance education in schools.

Implementation, monitoring, evaluation, and research

To monitor the new regulatory system for potential harms and benefits, rigorous evaluation will be integral. Close oversight of production, data on purchasing patterns, and monitoring potential adverse consequences will be critical.

Conclusion

The increasing interest in psychedelic science, medicine, spirituality, and other related experiences is an important societal development. However, the risk/benefit profile of psychedelics necessitates a thoughtful public health approach guided by both experiential and research evidence and anthropological insights.