Psychedelic Medicine Task Force
Psychedelic Medicine Task Force
In the 2023 legislative session, the Minnesota Legislature established a Psychedelic Medicine Task Force (“PMTF”) to advise it on the legal, medical, and policy issues associated with the potential legalization of psychedelic medicine in the State of Minnesota. MDH is required by law to provide meeting space and administrative services for the PMTF. All materials produced by the PMTF, including meeting notes, recommendations, and reports, are products of the PMTF, not MDH. MDH staff may perform tasks, such as summarizing available research, at the request of the PMTF, but any such materials should not be construed as the position of MDH or the State with regard to the potential legalization of psychedelic medicine.
Read more: Minnesota Statutes, section 99: Psychedelic Medicine Task Force
To view the current membership of the Psychedelic Medicine Taskforce, please visit Minnesota Secretary of State Board/Commission Psychedelic Medicine Task Force.
For more information, or if you would like to share resources, expertise, or other personal experiences, contact health.psychedelicmedicine@state.mn.us. Task force members will assess and post opportunities for public input below as work continues.
For purposes of this task force, "psychedelic medicine" refers to three distinct drugs with potential to treat certain medical conditions: psilocybin, 3,4-methylenedioxymethamphetamine (MDMA), and lysergic acid diethylamide (LSD).
Task force members will include:
- The governor or a designee
- Two members of the house of representatives, one appointed by the speaker of the house and one appointed by the minority leader of the house of representatives, and two members of the senate, one appointed by the senate majority leader and one appointed by the senate minority leader
- The commissioner of health or a designee
- The commissioner of public safety or a designee
- The commissioner of human services or a designee
- The attorney general or a designee
- The executive director of the Board of Pharmacy or a designee
- The commissioner of commerce or a designee
- Members of the public, appointed by the governor, who have relevant knowledge and expertise, including:
- Two members representing Indian Tribes within the boundaries of Minnesota, one representing the Ojibwe Tribes and one representing the Dakota Tribes
- One member with expertise in the treatment of substance use disorders
- One member with experience working in public health policy
- Two veterans with treatment-resistant mental health conditions
- Two patients with treatment-resistant mental health conditions
- One psychiatrist with experience treating treatment-resistant mental health conditions, including post-traumatic stress disorder
- One health care practitioner with experience in integrative medicine
- One psychologist with experience treating treatment-resistant mental health conditions, including post-traumatic stress disorder
- One member with demonstrable experience in the medical use of psychedelic medicine
The task force shall:
- Survey existing studies in the scientific literature on the therapeutic efficacy of psychedelic medicine in the treatment of mental health conditions, including depression, anxiety, post-traumatic stress disorder, bipolar disorder, and any other mental health conditions and medical conditions for which a psychedelic medicine may provide an effective treatment option
- Compare the efficacy of psychedelic medicine in treating the above conditions with the efficacy of treatments currently used for these conditions
- Develop a comprehensive plan that covers:
- Statutory changes necessary for the legalization of psychedelic medicine
- State and local regulation of psychedelic medicine
- Federal law, policy, and regulation of psychedelic medicine, with a focus on retaining state autonomy to act without conflicting with federal law, including methods to resolve conflicts such as seeking an administrative exemption to the federal Controlled Substances Act under United States Code, title 21, section 822(d), and Code of Federal Regulations, title 21, part 1307.03; seeking a judicially created exemption to the federal Controlled Substances Act; petitioning the United States Attorney General to establish a research program under United States Code, title 21, section 872(e); using the Food and Drug Administration's expanded access program; and using authority under the federal Right to Try Act
- Education of the public on recommendations made to the legislature and others about necessary and appropriate actions related to the legalization of psychedelic medicine in the state.
Task force meetings
Time: Meetings will generally be held on the first Monday of each month from 9:30 a.m. to 12:30 p.m. with the exception of holidays.
Updated location: The November and December meetings will be held in the Central Park Room on the fourth floor of the Centennial Office Building: 658 Cedar Street in Saint Paul.
Guests will need to check in with the security desk when they arrive to be escorted to the fourth floor.
Meetings will be accessible to the public and will be streamed live during meeting times via the task force’s YouTube channel. The public is also able to join in person in a space scheduled prior to meeting. At least one staff member will be in attendance, as required by open meeting law, while the majority of members will be attending virtually.
A schedule of upcoming meetings is referenced below.
- Nov. 6, 2023
- Dec. 4, 2023
- Jan. 8, 2024
- Feb. 5, 2024
- March 4, 2024
- April 1, 2024
- May 6, 2024
- June 3, 2024
- July 1, 2024
- Aug. 5, 2024
- Sept. 9, 2024
- Oct. 7, 2024
- Nov. 4, 2024
- Dec. 2, 2024
Nov. 6, 2023
- November Agenda (PDF)
- Draft Psychedelic Medicine Task Force Charter (PDF)
- November Meeting Slides (PDF)
- November Meeting Summary (PDF)
Dec. 4, 2023
- December Agenda (PDF)
- Draft Task Force Charter V2 (PDF)
- December Meeting Slides (PDF)
- Draft Scientific Research Methods (PDF)
- December Meeting Summary (PDF)
Jan. 8, 2023
- January Agenda (PDF)
- January Meeting Slides (PDF)
- Draft Task Force Charter V3 (PDF)
- January Meeting Summary (PDF)
Feb. 5, 2024
- February Agenda (PDF)
- February Meeting Slides (PDF)
- Task Force Charter V4 (Word)
- February Meeting Summary (PDF)
March 5, 2024
April 1, 2024
- April Agenda (PDF)
- April Meeting Slides (PDF)
- April Meeting Summary (PDF)
- LSD Literature Overview (PDF)
May 6, 2024
- May Agenda (PDF)
- May Meeting Slides (PDF)
- Legal Work Group Update (PDF)
- Draft Task Force Chairperson's Role (PDF)
- Draft Task Force Vice Chairperson's Role (PDF)
- May Meeting Summary (PDF)
- Psilocybin Literature Overview (PDF)
June 3, 2024
July 1, 2024
Aug. 5, 2024
- August Agenda (PDF)
- August Meeting Slides (PDF)
- Community Research and Population Statistics Summary (PDF)
- Psychedelic Medicine Task Force Initial Draft Report Notes (PDF)
- Psychedelic Medicine Task Force Recommendations Development (PDF)
- August Meeting Summary (PDF)
Sept. 9, 2024
- September Agenda (PDF)
- September Meeting Slides (PDF)
- Phase II MDMA Trials (PDF)
- Psychedelic Medicine Task Force Final Report Outline
- September Meeting Summary (PDF)
Oct. 7, 2024
Nov. 4, 2024
Reports
The task force will submit their findings and recommendations to the legislature. As reports become available, they will be posted on this page.
Psychedelic Medicine Task Force Legislative Report: February 2024 (PDF)
Psychedelic medicine overview
For purposes of this task force, "psychedelic medicine" refers to three distinct drugs with potential to treat certain medical conditions: psilocybin, 3,4-methylenedioxymethamphetamine (MDMA), and lysergic acid diethylamide (LSD).
Overall limitations of the research
Current research into both the efficacy and safety of these drugs is limited in both the overall number of trials, the total number of participants, and the medical conditions being investigated. While double-blind randomized controlled trials are considered the gold standard for the development of new medications and treatments, these studies have a number of known limitations. Participants in the trials often do not reflect the real-world population, since these studies frequently exclude individuals with certain health conditions, both mental and physical, as well as limiting the use of certain other medications during the trial. Clinical trials also frequently do not include a diverse group of individuals, and the sample sizes of many trials are small.
These types of trials are designed to determine the efficacy of a treatment, which refers to how well it works in tightly controlled conditions. It is not until a medication is on the market and in use by the general public that measures of its effectiveness (how well it works in real-world situations) can be understood. Clinical trials are often focused on a single outcome over a specific amount of time, and so any other effects of the treatment, including long-term effects, are often unable to be reported.
Furthermore, there are several additional limitations inherent to the study of psychedelic medicines in general, including inability to blind the studies (functional unblinding), expectancy bias, and limited ability to directly compare efficacy to current gold-standard treatment.
Functional unblinding
The first unique challenge when conducting clinical trials of psychedelic drugs concerns "blinding" (the process of keeping both participants and administrators unaware of the drug condition). Because the experiences elicited by psychedelic drugs are distinct, participants (and clinicians) are almost always able to correctly guess if they received the drug or the placebo; this is called functional unblinding. When explicitly measured, functional unblinding was found to occur in a substantial portion of the clinical trials for MDMA, psilocybin, and LSD.
Expectancy bias
Another related challenge is the expectancy effect, which refers to how the participant's belief about the drug they may (or may not) receive can influence the outcome. This is a particular concern with the media attention surrounding psychedelic drugs, which can influence participants' expectations about their effects. Related to this, another set of limitations that can influence outcomes are the placebo effect (seeing an effect while not having received the drug of interest), and the “nocebo” effect (wherein participants who expect that they will feel better after receiving a treatment may be disappointed if this is not the case, sometimes leading to worsening symptoms).
Small sample size
Finally, given that clinical trials investigating these substances are newly re-emerging after a period of relative prohibition, the sample sizes within the studies are small, making it difficult to draw concrete conclusions from the results. This factor also makes it difficult to directly compare the efficacy of psychedelic drugs with that of current standard treatments, which are typically backed by data collected from thousands (to tens of thousands) of individuals over hundreds of clinical trials, as well as supported by data from use in the “real world” outside of clinical trials.
Psilocybin
Psilocybin is a naturally occurring substance found in certain species of fungi (“magic mushrooms”). On its own the compound is inactive, but through metabolism becomes the psychoactive psilocin. Psilocin has a chemical structure similar to the neurotransmitter serotonin and binds to serotonin (and other) receptors in the brain. Psilocybin has a long history of use in many Indigenous cultures due to its potential to induce altered states of consciousness and elicit spiritual experiences. Recent clinical studies have investigated psilocybin-assisted therapy as a potential treatment for a number of health conditions, including major depressive disorder, treatment-resistant depression, anxiety, alcohol use disorder, and others. Between 2018 and 2019 the FDA awarded Breakthrough Therapy designation to psilocybin for both major depressive disorder and treatment-resistant depression. A number of phase II clinical trials have yielded positive results in the treatment of these conditions.
However, there are a number of limitations with these studies, both common to all clinical trials and specific to psychedelic trials (see "Overall limitations of the research" section for detailed explanation). First, the sample size of each study was relatively small, and those within the trials did not have any other underlying health conditions nor were they allowed to take certain other medications, making it difficult to draw conclusions to a wider population. Due to the nature of psilocybin, it was difficult to create a condition in which the participant did not know they had received the drug (functional unblinding). Attempts to counter this focused on giving participants a small dose of the drug, but this results in the lack of a true placebo group with which to compare results. Therefore, more research surrounding psilocybin is necessary to draw conclusions about its efficacy.
MDMA
MDMA (3,4-methylenedioxymethamphetamine) is a synthetic drug that in recent years has shown therapeutic potential for the treatment of certain mental health conditions, particularly post-traumatic stress disorder (PTSD), but also anxiety disorders associated with other conditions. Treatment with MDMA typically involves s concurrent intense therapeutic component, and certain studies have focused specifically on treating veterans and first -responders suffering from moderate-to-severe PTSD. In 2017 the FDA granted Breakthrough Therapy designation to MDMA-assisted therapy for the treatment of PTSD, and two phase III clinical trials were submitted to the FDA as a potential new drug. While the initial results from these trials reported promising results, in August 2024 the FDA declined to approve the drug, but rather requested an additional clinical trial addressing safety data.
Similar to the other psychedelic drugs, limitations common to all clinical trials and specific to psychedelics occurred in the studies (see "Overall limitations of the research" section for details). Between these trials the total sample size was relatively small and excluded those with certain other conditions and taking specific medications. Functional unblinding was reported to be very high; between the two trials 94% of participants correctly guessed that they had received the drug. Additionally, within these trials nearly 40% of participants reported past use of MDMA, which may also have an effect on the results. Overall, more data on both the efficacy of treatment and the effects of the drug on the body and brain are necessary to draw conclusions on MDMA-assisted therapy as a treatment option.
LSD
LSD (lysergic acid diethylamide) is a synthetic hallucinogen that is most well-known for its mind-altering effects and association with the 1960s counterculture. Recently the drug has been investigated as a treatment for anxiety--including generalized anxiety disorder and anxiety that surrounds life-threatening illnesses. LSD has been clinically tested both with and without a therapeutic component, and results are generally positive in alleviating symptoms of anxiety.
However, there have been fewer clinical studies testing LSD than there have been with either psilocybin or MDMA, limiting the conclusions that can be drawn regarding efficacy. Additionally, studies on LSD are subject to the same limitations of all clinical trials and those for psychedelics specifically (see "Overall limitations of the research" for details). The total sample size of participants included between all the trials is relatively small, and excluded those with comorbid mental or other health conditions. Like with MDMA, functional unblinding within the studies was high, and some studies used a low dose of the drug in place of a true placebo, potentially limiting conclusions on efficacy. Like with the other drugs, more clinical trials in the coming years will be necessary to understand any therapeutic efficacy of LSD.
Resources
- National Institutes of Health: History repeating: guidelines to address common problems in psychedelic science. A history publication on limitations of psychedelic trials.
- FDA: Considerations for Psychedelic Clinical Investigations
- Johns Hopkins Psychedelics Research and Psilocybin Therapy
- Oregon Health Authority Psilocybin Services
- Colorado Natural Medicine Act
- Lykos Therapeutics: Response to FDA Ruling on MDMA
- Multidisciplinary Association for Psychedelic Studies
- MindMed Announces Positive Data from Phase 2 Trial Evaluating LSD in Anxiety Disorders
- Compass Pathways Publications and Reports on Psilocybin