In late December 2023, we reported on how an election-occasioned changing of the guard around the Kentucky Opioid Abatement Advisory Commission (KYOAAC) left an ambitious plan to cleave off $42m in opioid settlement funds for ibogaine research politically untenable (See Kentucky’s $42m Ibogaine Funding Appears Dead in the Water).
Once that became clear, the loose coalition of ibogaine funding advocates—led by former KYOAAC Chairman Bryan Hubbard—upped sticks and searched for a new state to house their project. Now, that new home has become clear: Ohio.
In this article, we explore the magnitude of opioid settlement funds available in Ohio; the funding mechanisms we expect ibogaine advocates to tap in support of their renewed initiative; why advocates believe Ohio makes sense as a potential champion of this work; and, the challenges ahead for such an ambitious project.
A Bigger Pot
With more than double the population of Kentucky, the neighbouring state of Ohio is also lined up to receive substantially more opioid settlement money. In total, those funds are expected to be in the order of $2 billion over the next 17 years.
While Kentucky’s opioid funds were split evenly between an Opioid Abatement Trust Fund and local government, Ohio’s funds are divided in a tripartite manner: 15% goes to the state, 55% to the OneOhio Recovery Foundation, and 30% to local government. That means that the private non-profit, OneOhio, has just over $1 billion in funds lined up.
The Two Ways Advocates Hope to Fund Ibogaine Development in Ohio
We understand that funding for ibogaine research and drug development is being pursued via two mechanisms in Ohio.
The first resembles that pursued in Kentucky: soliciting a significant sum of opioid settlement funds for a public-private partnership model. The second would seek to establish a ‘Pay for Success’ program in the Ohio Treasurer’s office.
Here, we review each mechanism.
Pitching A Public-Private Partnership to the Billion-Dollar OneOhio Foundation
Hubbard told Psychedelic Alpha that, along with the REID Foundation 1, he will aim to “make the compelling scientific and humanitarian case for direct state investment in the expeditious creation of an ibogaine therapeutic as a breakthrough treatment of opioid disorder.”
One such funding body they will make that case to is the OneOhio Recovery Foundation, which is responsible for the custody and distribution of north of $1 billion in opioid settlement funds. Hubbard explained that they would be presented with the same public-private partnership model that was developed in Kentucky.
Under that model, Hubbard further explained, a “small percentage” of state funds would be pledged to match the investment of a private entity, which could be a non-profit or for-profit.
That funding would be geared toward obtaining the green light from the FDA to commence clinical trials with ibogaine. Under the planned model, once that approval is obtained the state’s contribution would be unlocked to cover the costs of clinical trials in Ohio.
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At present, none of OneOhio’s funds have been distributed. It’s not clear that the public will be kept clued in on that process when it begins, either.
In a unanimous decision last Spring, the Supreme Court of Ohio ruled that OneOhio’s records should be considered public. Soon after that decision, however, the 2024-25 Senate budget bill included a provision which sought to clarify that the Foundation is not a state entity, and thus should be exempted from the requirements of public office such as public record requests. This effectively overturned the supreme court’s decision.
Speaking to the Ohio Capital Journal, Harm Reduction Ohio’s Dennis Cauchon described the arrangement as “a petri dish for corruption.” (Cauchon was the impetus for that state supreme court case after he sued OneOhio when it ignored his public records request and turned him away from a meeting.) The nomination process for the OneOhio’s executive director has also been criticised for lacking transparency, according to further reporting by the Journal.
As we reported in our piece on Kentucky’s ibogaine funding efforts, there have been concerns about the use of opioid settlement funds in many states, especially those—like Ohio—that haven’t made commitments to be entirely transparent to the public.
Just last month, an Ohio representative, Marcy Kaptur, teamed up with Iowa rep. Ashley Hinsen to introduce a Bill that would establish the Bipartisan Opioid Settlement Accountability Act. The Act would ensure “the funds that states receive from opioid settlements are used to fight the epidemic and are focused towards treatment, prevention, education, and enforcement.”2
For now, OneOhio appears to have latitude in how it distributes funds; assuming federal efforts to tighten up such uses do not prevail. The Foundation can make both grants and investments, and can do so at both the state and regional level, for example. It also appears to have some shelter from public scrutiny.
A Trip to the Treasure’s Office: A Pay for Success Program via ResultsOHIO
Hubbard has also been retained by ResultsOHIO, part of the Ohio Treasurer’s office. ResultsOHIO is described by that office as, “an infrastructure within the [Ohio] Treasurer’s office that enables policymakers and innovators to pursue pay for success (PFS) projects aimed at tackling the most pressing social and public health challenges facing Ohio.”
A pay for success model sees upfront costs footed by private funders 3, with government repayment—which is usually set aside at the commencement of a project—only kicking in once pre-defined metrics are obtained.
According to Hubbard, he will help to develop a pay for success program that aims to provide novel treatment access and research for veterans affected by traumatic brain injury (TBI) and PTSD, as well as individuals with opioid use disorder (OUD).
A number of Ohio-based philanthropists are following ibogaine closely, we understand. Indeed, a recent publication by Nolan Williams and colleagues (2024) has only increased such interest, according to Hubbard, who described the study’s findings as ‘blockbuster’.
We might expect any funding that’s channeled through this payment for success program to be substantially smaller than that solicited from the state’s opioid settlement funds, though.
ResultsOHIO notes that, ideally, “costs for projects under the ResultsOHIO model range between $1-2 million – meaning the private funder has committed to spend $1-2 million and policymakers would appropriate $1-2 million for potential reimbursement expenses should predetermined outcomes be achieved.” For example, iSee, a project that sought to improve access to vision services, appropriated $1.2m from the 2022/23 budget.
What’s more, the ideal project duration is 2 years.
As such, if any substantial ibogaine development were funded via this mechanism, it would be many times larger than this sweet spot on both cost and timeframe. Instead, we might expect to see smaller projects, if any, funded via this route.
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As a result, it looks like the two efforts will be related but separate, with an ambitious pitch to OneOhio looking substantially similar to that made to its Kentucky counterpart and a potential pay for success program providing another model to facilitate ibogaine research and development in The Buckeye State.
Rick Doblin, founder of the Multidisciplinary Association for Psychedelic Studies (MAPS), told Psychedelic Alpha that he is excited about these attempts to secure funding from such sources and the type of research and drug development activity it might facilitate.
“The potential for public money for ibogaine drug development means that, in the midst of hundreds of for-profit psychedelic companies trying to patent everything under the sun to block generics, ibogaine could be developed to maximize public benefit”, he said.
A Natural Home for Ibogaine Research?
Aside from the substantial volume of opioid settlement funds, why else might Ohio serve as a natural home for this type of project?
Hubbard—who is known for his orations which often border on polemic—emphasised the history of the state when speaking with Psychedelic Alpha. “From the Underground Railroad in the 19th Century to the Hillbilly Highway in the 20th and 21st Centuries, Ohio has also been the historical destination of refuge for those in Kentucky who seek to overcome its tragic history of repressive political corruption in order to drive progress at home from afar”, he said.
But there’s also the stark reality that Ohio is among the states with the highest mortality rates from opioid overdoses, according to modelling by Cooper et al. (2020), and has seen alarming increases in the rate of so-called ‘deaths of despair’.
Those familiar with the ibogaine research literature might also see the state as a natural home for such a project given work by researchers at the Ohio State University (OSU). Alan Davis, for example, has co-authored several papers on ibogaine in the last decade.
In 2017, OSU’s Davis worked with colleagues at Yale and practitioners at the Crossroads Treatment Center in Mexico to publish on the self-reported effectiveness of ibogaine in treating problematic opioid consumption. The study surveyed 88 patients who had received ibogaine treatment in Mexico between 2012 and 2015, and indicated that ibogaine was associated with reductions in opioid use (Davis et al., 2017).
In 2020, Davis and his academic and practitioner colleagues published another survey, this time looking at Veterans who had received ibogaine and 5-MeO-DMT in Mexico. They found that the intervention held great promise (Davis et al., 2020).
As recently as last September, Davis and colleagues published an open-label study of sequential ibogaine and 5-MeO-DMT assisted therapy in Special Operations Forces veterans with a history of trauma. They once again reported potential and reiterated that controlled studies are needed (Davis et al., 2023).
A few months later, Nolan Williams and his Stanford colleagues’ aforementioned magnesium-ibogaine study was published in Nature Medicine. The open-label study suggested that the intervention “could be a powerful therapeutic for the transdiagnostic psychiatric symptoms that can emerge after [traumatic brain injury]” (Williams et al., 2024).
Davis, who was outspoken in his support of Kentucky’s efforts to carve out funding for research into ibogaine, is presumably excited about the initiative’s move to Ohio. “This funding is crucial for the future of ibogaine development in the U.S.”, he told Psychedelic Alpha.
The REID Foundation, meanwhile, highlighted Williams et al.’s study, suggesting that the Ohio ibogaine ‘effort’ will build off of that work, with the goal of executing ‘FDA-approved clinical research trials’ with ibogaine for opioid dependence in the state.
Hubbard was keen to point out that the Ohio State University would be “an integral part” of realising the initiative’s ambitions.
Ibogaine Drug Development: Not for the Faint-Hearted
As we mentioned in our coverage of the Kentucky effort, bringing a drug through the FDA approval process is expensive, with costs often measured in the hundreds of millions or even billions of dollars. Kentucky’s $42 million proposed carve-out, then, seemed to dwindle in comparison to this sum.
What’s more, given ibogaine’s exceedingly long duration of effects, even when compared to other psychedelics, and cardiac risk profile (Nolan Williams told Tim Ferriss that the drug has a “roughly 1 in 300 chance of death”), it’s likely to be a particularly difficult drug to develop.
Indeed, Hubbard admitted that, “as was the case in Kentucky, this is an aspirational endeavour.”
Outside of this initiative in Ohio, a number of for-profit efforts to develop ibogaine into an FDA-approved drug are underway.
DemeRx IB, an atai Life Sciences program, is developing its ibogaine candidate (DMX-1002) in OUD, for example.
But, as we reported last August, Phase I results from DemeRx’s study of its ibogaine candidate being developed for OUD were a bit of a damp squib. While the clinical trial registry entry for the study included four potential doses (3, 6, 9, and 12 mg/kg), the 12 mg/kg dose was not mentioned in a press release which briefly described the results. An ibogaine practitioner who spoke with Psychedelic Alpha suggested that doses in excess of 10 mg/kg are regularly employed in the unregulated space, especially in individuals with substance use disorders. If this is the case, DemeRx’s Phase I data might not be so useful for those looking to employ higher doses in later-stage trials.
Gilgamesh Pharmaceutical is also developing ibogaine-related drugs. Its GM-3009 candidate, is a “novel cardiac safe Ibogaine analog” which has been, “designed based upon >15 years of research on the pharmacology and medicinal chemistry of ibogaine”, the company told Psychedelic Alpha. The candidate, which is yet to reach in-human studies, is protected by composition of matter intellectual property, Gilgamesh added.
And, as we noted in our contemporary coverage (see Pα+ Psychedelic Bulletin #153), some of the co-authors of the Stanford study, including Nolan Williams, are listed as inventors on two unpublished patent applications related to the therapeutic use of ibogaine.
Despite this commercial activity, the fact remains that there is a dearth of published clinical trial data on the compound. As such, it’s likely that any Ohio-driven effort will have to start from a very early phase of development.
OSU researcher Alan Davis and DemeRx’s founder Deborah Mash, however, have devised a plan that they think will allow them to leapfrog to Phase II.
“It’s going to remain an expensive and time consuming endeavor without better real-world data on the risks and benefits associated with ibogaine treatment”, Davis told us, “which is why I’ve partnered with Dr. Deborah Mash on the first global ibogaine patient survey.”
The Ibogaine Patient Survey aims to collect self-reported data from people who have taken ibogaine as an intended treatment for addiction or other disorders. That data, Davis hopes, “will be used to help establish better estimates of ibogaine safety for future FDA submissions.”
Next Steps
Melissa Lavasani, founder and CEO of Psychedelic Medicine Coalition (and co-founder and President of Psychedelic Medicine Advocacy), was keen to temper expectations when speaking with Psychedelic Alpha.
“The prospect of Ohio potentially using opioid settlement funds is very exciting”, she said. “However, we are fresh off the heels of a similar initiative in Kentucky failing”, she warned, adding that “we must not get ahead of ourselves and understand there is a lot of work to be done in Ohio for this initiative to be successful.”
That work, Lavasani told us, includes extensive public education, achieving buy-in from local political leaders, and the creation of a costed campaign plan. Without this legwork, “it will fail again”, she said, adding that it could be the end of the road for similar opportunities in other states as well.
For his part, Doblin was as exuberantly optimistic as ever. “Though in the end unsuccessful,” he told Psychedelic Alpha, “the Kentucky effort to allocate $42 million of its opioid settlement money to research ibogaine for opiate dependence has inspired at least one other State to explore doing so.”
“With public money, ibogaine could be developed in an open science context that places all IP in the public domain without seeking any patents and with ibogaine to be sold as a generic medicine immediately after approval”, he continued.
It’s not yet clear, however, what role—if any–for-profit companies and investors might play in this model.
Indeed, most of the details of this effort remain unclear for now. Psychedelic Alpha understands that a press conference was expected to be held yesterday, with participation from the Ohio Treasurer’s office. It has evidently been postponed, presumably to allow more time for the various stakeholders from within the state and beyond to get their heads around the potential mechanics of such a program.
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- The REID Foundation (‘Reaching Everyone in Distress), is a “501(c)(3) nonprofit dedicated to utilizing the healing power of music, creative expression, and emergent therapies to bring ‘front-line therapy’ and prevention to those impacted by the opioid crisis, substance abuse, and mental health issues.” The organisation cites Psychedelic Medicine Advocacy and Reason for Hope among its partners.
- Interestingly, it is not clear whether investing in the research and development of drugs like ibogaine for opioid use disorder is covered by the allowable uses described in the bill, though the case might be made that it falls under some of the more vague uses—see Sec. 2.
- It’s not clear whether funds from the likes of OneOhio might be considered to be private funds for the purposes of a PFS program, given ongoing discussion surrounding how closely it resembles a public body (discussed later in this piece).
