This roundup is the first in a series of regular reviews of state-level activity on psychedelics policy and regulatory action, intended for policy experts closely tracking these emerging developments. The series will review psychedelics-related policy proposals, public agency and legislative committee hearings, analyze proposed legislation, and more.
Massachusetts Ballot Initiative to Legalize Psychedelics Gains Momentum
A group of activists led by New Approach PAC is pursuing a psychedelic legalization initiative in Massachusetts as a 2024 ballot measure. The ballot initiative would, similar to Colorado’s Proposition 122, task the state to design a regulatory framework for professional psychedelic services, and it would remove criminal penalties for personal possession and cultivation of up to one gram of psilocybin, one gram of psilocyn, one gram of dimethyltryptamine (DMT), 18 grams of mescaline, and 30 grams of ibogaine.
As of October, proponents of the Massachusetts measure believe they already have enough signatures to qualify for the state’s 2024 election.
If passed, prior to the subsequent launch of the Massachusetts’ regulated market, independent commercial activity would remain illegal, as the ballot initiative would not permit retail sales of psychedelics.
That said, like Colorado’s Proposition 122, the proposed Massachusetts initiative would not prohibit adjunct therapy services for individuals who provide their own psychedelic products. It also may allow practitioners to sell services while “giving away” psychedelics (the so-called “gifting loophole”). For instance, if a trip-sitter charges $200 to guide someone through an experience but gives away mushrooms (and does not charge any money, no matter how many mushrooms are given), then the psychedelics are considered a “transfer without remuneration” and thus legal. The gifting loophole is potentially legal, but it might depend on how a court interprets gifting concurrently with a service. No court cases in the U.S. have addressed the gifting loophole for psilocybin.
The New Approach PAC considered two potential ballot proposals—one permitting home cultivation and one without it. Based on private polling, New Approach ultimately decided that home cultivation was politically viable. Home cultivation products are available online, and there is a thriving cottage industry of kits that attempt to make cultivation easy for beginners.
Conceptually, the proposed initiative is very similar to Colorado Proposition 122, which voters approved in November 2022. A preliminary report from Reason Foundation found that Colorado’s law permitting personal possession has not threatened public health and allowed broad access to legal psychedelics in the months since implementation. Reason Foundation examined prospective changes in public crime data and interviewed authorities from the criminal justice and healthcare sectors on the impact of legal botanical psychedelics. According to publicly available data for the first months after legalization, there was no noticeable increase in crime involving hallucinogens. Law enforcement and hospital representatives told Reason Foundation researchers that they had not seen an uptick in psychedelic abuse.
Generally speaking, the legalization of psychedelic substances enjoys strong national support, according to polling from the University of California-Berkeley’s Center for the Science of Psychedelics. Ballot initiatives have faced relatively little opposition, with most opposition coming from center-left groups concerned with how regulations could severely restrict access, especially to lower-income individuals. For example, in Colorado, a left-leaning advocacy group argued that Proposition 122 would create an expensive and overregulated market, but after Prop. 122 passed, it recanted its opposition.
Given the emergent enthusiasm for psychedelic legalization following victories in Oregon and Colorado, momentum is on the side of a prospective ballot measure in Massachusetts. Initiative organizers are waiting for state officials to verify that they have met the required threshold of 75,000 verified signatures. In Massachusetts, the legislature can respond to an initiative petition by concurrence or proposing a substitute. If the legislature declines, petitioners have until July to collect an additional 12,429 signatures to qualify the initiative for the 2024 election.
Colorado Advisory Board Considers Regulated Psychedelic Therapy
Colorado’s Proposition 122, approved by voters in November 2022, requires the state to appoint an advisory board to make recommendations on regulating facilitated services for psychedelic therapies. Advisory board hearings began earlier this year (official meeting minutes available here) and, to date, have generally focused on logistics and the presentation of expert testimony to board members. A summary of noteworthy ideas presented at Colorado’s recent hearings follows:
Colorado Emergency Medicine Subcommittee update
In its Sept. 13 hearing, the Colorado subcommittee discussed:
- If facilitation (the professional oversight of a psychedelic experience) is allowed outside of a designated psychedelic healing center, what minimum safety requirements (e.g., having emergency contact information, having rescue medications available, etc.) might be warranted;
- How to protect consumers from abuse or unsafe facilitation and whether sessions might include a second person or a recording device;
- What additional factors should be considered for facilitation at locations like private homes, hospitals, or outdoor settings; and
- Whether drug testing of consumers should be required before they are administered psychedelic products.
Colorado Health Equity Subcommittee update
In its Sept. 14 hearing, the Health Equity Subcommittee discussed:
- Whether facilitators practicing under the religious or indigenous use exemption can receive donations consistent with their traditions;
- Different recommendations related to facilitator licensing, including ways to reduce fees or provide inexpensive education based on income, such as mentorship programs or free state education programs, facilitator independence from healing centers, and licensure by endorsement; and
- Alternative pathways to licensure, such as a portfolio review process.
Colorado Product Testing Subcommittee update
In its Sept. 20 hearing, the testing subcommittee discussed:
- The experience of one provider dealing with Oregon’s regulated market who detailed several regulations that increase costs and risks, especially for small vendors;
- For instance, this provider noted that Oregon only allows one species of mushroom and if there was a simple mistake in the process of verifying the mushroom species, he might have to throw out his entire crop;
- Using Good Agricultural Practices (GAP) as a basis for cultivation standards; this requirement could be flexible depending on business size since it could overly burden small cultivators; and
- Allowing the use of other substrates, such as manure, to grow mushrooms.
Colorado Qualification Licensing and Training Subcommittee update
In its Sept. 21 hearing, the licensing and training subcommittee discussed:
- The content of an extended presentation from Hadas Alterman, government affairs director for the American Psychedelic Practitioners Association, regarding training standards;
- Alterman argued that while many standards could potentially increase training costs, guidelines are necessary to convince insurance providers to cover psychedelic therapy; and
- Whether there are possible alternatives to requiring completion of training hours to qualify for a license, such as mentorship and experience.
Colorado Emergency Response, Safety and Ethics Subcommittee update
In its Sept. 13 hearing, the safety subcommittee discussed:
- Challenges around informed consent and allowing consumers to designate a second person to act legally on their behalf;
- Ways to prevent abuse, which could include video recordings or additional staff in the room;
- Allowing facilitation outside of a healing center and what precautions would be needed;
- The ability to allow telehealth preparation; and
- Whether consumers should be drug tested before being allowed to sit for an experience.
Additionally, representatives from Colorado’s different subcommittees held a hearing on Oct. 20 that included new information on the upfront capital expense necessary to become a certified facilitator in Oregon presented by Lundy, CEO of mental health companies and member of Colorado’s advisory board. Lundy claims those expenses could amount to roughly $52,000 during the first year, after taking into account $15,000 in insurance expenses, $5,000 in required training, plus facility rental and other licensing fees (see chart below).
Figure 1. Hypothetical first-year facilitator costs in Oregon
|Category||Before Licensed||Day One Licensed||Monthly Overhead||Total Year-One|
|Essential Costs||Total Additional Expenses|
|Facilitator License Fee||$2,000||$2,000|
|Total Additional Expenses||$2,500||$100||$3,700|
|Total Essential Expenses||$8,500||$17,500||$350||$30,200|
|Licensed Premises License||$2,000|
|Rent /Lease (shared space)||$2,000||$1,000||$14,000|
|Total Addtional Expenses||$2,000||$2,000||$1,500||$22,000|
To reduce costs associated with education and training in Colorado, the subcommittee discussed whether it would be possible to allow applicants to bypass training requirements if they can demonstrate competence on an exam. Board member Alisa Hannum noted that, unlike Oregon, Colorado might need new legislation to allow certification through a test.
Oregon’s advisory board took a more cautious route that mandated more than 100 hours of training for every applicant regardless of experience level, among other rules. As a result, a single psychedelic session can cost more than $3,000. Oregon’s high prices have inspired Colorado’s board members to seek more cost-effective alternatives to regulation.
Kentucky Considers Millions in Ibogaine Funding
Kentucky is on the precipice of becoming the first state to use a portion of its opioid settlement money—$42 million out of $800 million in settlement funds—to finance clinical trials of ibogaine as a potential treatment for opioid use disorder. Ibogaine is a psychedelic substance derived from a West African shrub that shows early promise in both stemming physical withdrawal symptoms for opioid users and in helping users resolve mental dependency issues. Reason Foundation published a commentary on why funding ibogaine research may help the state with the opioid crisis.
In the runup to a planned vote in November on whether to allocate funding for this research, the Kentucky Opioid Abatement Advisory Commission, which is empowered to determine the use of settlement proceeds resulting from national opioid litigation, held public hearings on Sept. 15 (video here) and Oct. 17 (video here) as part of its ongoing deliberations.
The commission faced little opposition during its initial hearings and spurred little controversy. However, once the ibogaine research proposal garnered attention, a few academics voiced skepticism.
In particular, at the commission’s October public hearing, Dr. Mark Haigney, director of cardiology at the Uniformed Services University, gave a presentation on why he believes ibogaine is unlikely to help mitigate Kentucky’s opioid problem. He argued that the safety risks were substantial and would thus require intense heart monitoring, likely leading to an uphill battle for the Food and Drug Administration (FDA) approval of ibogaine as a treatment for opioid use disorder.
“The likelihood that this drug with this safety profile would be approved by the FDA in less than 10 years, in my opinion, is remote,” according to Haigney.
When Commission Chair Bryan Hubbard questioned Haigney, citing observational evidence there had only been roughly 30 recorded deaths out of approximately 10,000 ibogaine administrative sessions, Dr. Haigney remarked that this was simply anecdotal and not done in a clinical setting, “That is not evidence in the world of science,” Haigney stated. “The FDA will never accept that.”
Multidisciplinary Association of Psychedelic Studies (MAPS) founder Rick Doblin then gave testimony rebutting some of Dr. Haigney’s claims. Based on MAPS’s experience with clinical trials, he noted that ibogaine would likely receive a “breakthrough therapy” designation from the FDA. This designation confers priority status for FDA review of clinical trial data and can shorten the pathway for an investigational new drug to be granted new drug approval. Doblin, who has overseen FDA-supervised trials of MDMA as a treatment for post-traumatic stress disorder under a breakthrough therapy designation, estimated that ibogaine could be approved in less than six years and could finish two of three FDA trial phases for less than $100 million.
Doblin also noted that ibogaine clinics have now developed risk-prevention methods that “mitigate or completely” address potential cardiac complications.
Finally, in September, the commission invited several speakers to testify about their expertise and experience with ibogaine. Tommy Aceto, a former Navy SEAL, spoke about his own experience at a clinic in Mexico. This passage by Aceto highlights the risks and rewards of veterans who seek ibogaine treatment:
“I witnessed 10 veterans who all had dramatic healing experiences. The patients, they walk in broken, frail, and hanging on by a thread. You can see the hopelessness in their dull, empty eyes. One of the SEALS, a former student of mine, came through— his name is Jeff Reed—who had been suffering from debilitating cluster headaches for the past eight years as a result of firing rockets. He said it felt like someone was stabbing him in the back of his eyeballs with an ice pick. Jeff was prescribed opioids and became hooked on them. But the pain was too much even for the strongest opioids. Jeff told his wife a few months ago that he was going to take his life. He felt too much of a burden on his family. Fortunately, Jeff decided to take all their savings and come down to the Mission Within. After Jeff’s ibogaine treatment, I had the pleasure to talk to him. He reported that his headaches were gone. Not better—gone. And so was his addiction to opioids.”
It remains to be seen how many emotional and anecdotal stories like this could impact the current deliberations in Kentucky. The commission has not yet determined when a final vote will take place.