When Bryan Hubbard was appointed Executive Director of the newly formed Kentucky Opioid Abatement Advisory Commission in 2021, he had already been tracking psychedelic-assisted therapies in the media for three years. Kentucky had recently been awarded $842 million in settlement funds from lawsuits against opioid distributors and manufacturers for their role in an epidemic that has hit Kentucky particularly hard. The commission was tasked with allocating half of that money toward treatment efforts, with the other half going directly to local programs.
Hubbard felt compelled to do more than prop up the status quo, which clearly has not been working. There were over 80,000 deaths in the U.S. from opioid overdoses last year and Kentucky’s death rate is twice the national average. Current treatments for opioid use disorder, which center on maintenance opioids such as buprenorphine and methadone, are effective for about 25 percent of patients.
“My own brother died of a fentanyl overdose in January. Families all over the Commonwealth and country have been impacted,” says Ben Chandler, a former Attorney General of the state who served five terms in Congress. “What we have been doing doesn’t work well enough and costs too much money. Psychedelics have great potential, from what I can see.”
The Commission will soon vote to decide whether to commit ten percent of its funds, $42 million, toward a psychedelic-assisted therapy moonshot that could transform treatment for OUD nationally. The plan was announced at a press conference in May held by Kentucky Attorney General Daniel Cameron, who appointed Hubbard to lead the Commission. It would create a public-private partnership to pursue research and FDA approval for treating OUD with ibogaine, a powerful psychedelic compound derived from the West African plant iboga.
Hubbard’s Discovery of Ibogaine
While preparing the ibogaine plan, Hubbard did his homework. He knew that psychedelic compounds such as MDMA and psilocybin had received breakthrough therapy status from the FDA for treating Treatment Resistant Depression and Post-Traumatic Stress Disorder, and appear to be on track for official approval as legal medications starting in 2024. He read an NYU study in a peer-reviewed journal that showed psilocybin has the potential to treat alcoholism.
Then last year he came across a newsletter by a psychedelics advocate named Julia Christina that described how psilocybin had helped her overcome persistent anxiety, depression, and a near fatal eating disorder. “She wrote so beautifully that I sent her an email and asked if we could have a conversation,” says Hubbard.
“I told her what my job was, my position, and she was kind enough to give me some time at the end of July. I asked her, what can you tell me about the world of plant medicine that could be applied to opioid dependence? And she asked me if I had ever heard of ibogaine. I had not. She described it to me and said, you may want to look into this.”
Hubbard’s call with Christina led to more introductions, and eventually a dinner in New York with 13 ibogaine experts, including veterans advocates and researchers in the field. “I reviewed all the academic research given to me and became convinced that if we were looking to develop a breakthrough therapy that emancipates individuals from their physical, emotional, and spiritual subjugation within the dynamics of opioid dependence, that ibogaine appears to be the very best bet we could make,” he says.
Unlike current OUD treatments, ibogaine is not a maintenance drug and it is not addictive. It is known for having a potent and long lasting journey, which can go for as long as 36 hours. But unlike other psychedelics, according to researchers and advocates, it allows patients to seemingly skip much of the pain of withdrawal because of its mechanism of action on the opioid receptors.
According to Juliana Mulligan LMSW, a harm reduction expert at Inner Vision Ibogaine, a consultancy to ibogaine clinics, researchers theorize that ibogaine “resets the serotonergic and dopaminergic systems, leaving clients with a feeling of being reborn or ‘reset’ after their treatment. Many report that the visionary experience ibogaine offers reveals to them insights about past experiences or traumas, with many reporting visions of the cleaning out their brain, as if it were a filing cabinet.”
Mulligan adds, “No other treatment for opioid use disorder offers such intensive and regenerative work on a person’s neurochemistry.”
The Kentucky Ibogaine Plan
The initiative proposed by Hubbard calls for the creation of a public-private partnership to drive research into ibogaine therapy for OUD and to pursue FDA approval. The plan follows a model that is common for medicine development through the National Institute of Health or other federal agencies, but rare at the state level.
“So far as I know, this is the first time an individual state has taken this sort of action,” says Hubbard.
The Commission would issue a Notice of Funding Opportunity – analogous to a Request for Proposal – inviting a private company, academic institution or philanthropic foundation to collaborate with the state, similar to a standard grant making process open to qualified organizations. Hubbard explains, “We would require clinical trials at a minimum to occur in East Kentucky, as well as the West End of Louisville. We would also require that the clinical research entity match the commission’s money, and that they recognize the Commonwealth’s equity or economic interest in any patentable intellectual property which may be generated.”
It’s an ambitious vision. Drug development is a lengthy, expensive process that can take a decade or longer and cost hundreds of millions. Even the total of $84 million from the state and a private partner combined would take the research process only part way toward the critical Phase 3 clinical trials that the FDA requires, which themselves regularly cost $255 million on average. But Kentucky’s official involvement in such a program would likely attract additional resources down the road.
Hubbard expects as many as a half dozen organizations to bid for the partnership. “We’re casting a broad net to capture as many economically viable and scientifically competent organizations who can lay out their blueprint as to how they would help Kentucky achieve success as quickly, cautiously, expeditiously, and economically feasible as possible,” says Hubbard.
At a Commission hearing earlier this month, Rick Doblin, the founder of the Multidisciplinary Association of Psychedelic Studies, implied that MAPS could be one of those applicants. He testified that developing ibogaine as a treatment for substance dependency is MAPS’ next priority after gaining FDA approval for MDMA-assisted therapy to treat PTSD. MAPS PBC has recently completed Phase 3 clinical trials for the MDMA treatment and appears headed toward FDA approval next year.
Critics Voice Concerns
Some critics have raised concerns that are unique to ibogaine among psychedelics, particularly the cardiac risk that it poses for some patients. Ibogaine is known to prolong the QT level on an electrocardiogram, said Mark Haigney, Director of Cardiology at Uniformed Services University, which indicates a potential to cause cardiac arrest. Testifying at a Commission hearing in October, he said that “The finding of QT prolongation is the most common reason for removal of a drug from further development” by the FDA. He concluded that the FDA was unlikely to accept ibogaine as a subject for clinical trials.
Others who testified to the Commission disagreed. Among them was Deborah Mash, Professor of Neurology and Molecular and Cellular Pharmacology at the Leonard M. Miller School of Medicine, who appeared at a hearing in July. Mash has three decades of experience researching and leading treatment programs with ibogaine. In 1993, she opened a Phase 1 clinical trial at the University of Miami School of Medicine with FDA approval, and received the green light to expand the study in 1995, but was unable to secure the financing at the time.
Mash continues to pursue ibogaine treatment for substance dependency as founder and CEO of DemeRx, a drug development company. DemeRX received approval in 2021 to start a Phase 1 clinical trial for ibogaine treatment from the Medicines and Healthcare Products Regulatory Agency, the UK’s equivalent of the FDA.
“Drugs have risks,” Mash tells Lucid News. “To the best of my knowledge, the QT risk is a manageable risk. You can take ibogaine under a full medical monitor. Torsade, which can be a life-threatening arrhythmia [associated with QT prolongation], is a manageable event by a qualified doctor. Also, physicians can screen patients before admission to the study. There are certain patients who will not be fit to take ibogaine. And you have a risk mitigation plan built into the study to ensure safety of the people who participate in the clinical trials.”
The FDA has approved many medications that come with certain risks, Mash notes, adding that “methadone is a QT prolonging drug, and it’s a drug you take every day.”
Risks vs. Rewards with Ibogaine
The FDA will do a risk-benefit analysis of ibogaine, Mash says, and determine whether the potential cardiac danger is outweighed by the prospect of developing an effective OUD treatment. “What we know comes from open label research, but the good clinical practice studies need to be done by qualified investigators in controlled environments. If ibogaine really does help patients break the cycle of addiction and forge a new path to recovery, this will save us dollars and it will restore families, give children back their parents.”
Ibogaine treatment, however – like other psychedelic-assisted therapies – involves more than the administration of a drug. The substance is used as part of a protocol that also includes talk therapy. “It requires more than a dosing session for someone to achieve sustainable, long term benefit,” says Amber Capone, the cofounder of Veterans Exploring Treatment Solutions, an advocacy group that connects U.S. veterans suffering from a variety of mental health conditions to psychedelic-assisted therapies at retreat centers outside of the country. Capone testified at a Commission hearing in September.
“It’s not just about the administration,” Capone tells Lucid News. “It’s about the preparation and integration before and after, never failing to appreciate the role that integration plays during this window of opportunity following ibogaine for unpacking trauma, creating new neural pathways, establishing new habits and lifestyle shifts, not going back to the same toxic environment. The therapeutic piece is an absolute must.”
Capone insists that administration can be done safely. Over the past decade, VETS has provided ibogaine treatment to about 900 veterans, Capone says, and there have been no fatalities.
Mash also reports that during the few years when her retreat center offered ibogaine treatment legally in St. Kitts, starting in the late 1990s, 277 people were served safely.
Ibogaine Politics in Kentucky
As Hubbard gathered his research into ibogaine for the Kentucky Opioid Abatement Advisory Commission, meeting with leaders in the field, he became increasingly convinced of its potential to be a game changer for OUD.
“I put together a PowerPoint presentation and presented it to the Attorney General,” Hubbard says. AG Cameron had not heard of ibogaine, but he found Hubbard’s idea of using ten percent of the Commission’s funds to create a public-private partnership to be convincing. “With no small amount of courage and vision, he authorized the Commission to make a public announcement at the end of May.”
Some members of the Commission found themselves blindsided by the announcement. It took place at a well-orchestrated press conference led by Cameron and featuring a number of ibogaine treatment advocates. Most prominent among them was retired Marine three-star General Martin Steele, an ally of Kentucky Senator Mitch McConnell, who served in OperationDesert Shield/Desert Storm and Vietnam. Steele is the CEO of Reason for Hope, a nonprofit advocacy organization for psychedelic therapies, which consulted with Hubbard on the ibogaine plan.
Some Commission members learned of the ibogaine initiative from the press conference. According to unnamed sources in an article published in the Daily Beast, two commission members who are appointees and political allies of Governor Andy Beshear had not been briefed in advance and were taken by surprise. Cameron, who is a Republican, is running against Democrat Beshear for Governor in the election to be held on November 7. The Daily Beast article suggests that Cameron is supporting the ibogaine plan in return for a $3 million donation to his PAC by an influential conservative megadonor, Jeff Yass. The article points out that Yass would stand to benefit from the Kentucky program because, were it to go forward, it would boost the stock price of the psychedelic biotech company atai, in which Yass owns shares.
Strategic calculations did play a role in how the announcement was handled, Hubbard admits, though he says it doesn’t involve GOP megadonors. He points to a confrontation that took place a few months before, when Beshear criticized the Commission for not publicly issuing standards to be followed for grant applications.
“There was only one problem with that,” Hubbard says. “His own designees on the Commission on two occasions reviewed and voted for regulations that contained 12 individual standards by which grant applications were to be assessed and awarded. This set of regulations went to Andy Beshear’s desk for him to sign – these same standards that he stood up at a press conference and said did not exist.”
Mistrust between the Governor’s office and the Commission escalated. “How in the world was I going to get [Beshear] or anyone representing him to be constructively honest in the discussion of a proposal that presented the opportunity to be maligned and stigmatized, attacked by people willing to be inflammatory with the use of the word psychedelic – and all the negative connotations that come along with that?” says Hubbard.
Hubbard opted to make his case for the proposal to the entire Commission at once, through a series of public hearings. Working with Reason for Hope, he programmed three hearings with some of the field’s top experts. Together they offer a clinic on the potential efficacy of ibogaine treatment for OUD.
Governor Beshear’s office did not respond to a request for comment for this article.
Overcoming the Challenges
Is the Kentucky ibogaine plan becoming a political football, with the local red side in favor and the blue against? Such a turn in the politics would be noteworthy, considering how drug reform has long been seen as a Democratic issue. But Hubbard insists he doesn’t see this happening. “The support for this initiative is bipartisan, as is the opposition.”
He points to three reasons why some are opposed. The first is “good faith concerns about the cardiac toxicity issues that are raised related to ibogaine.”
A second reason he attributes to the stigma of psychedelics as “the party drugs of choice for irresponsible scofflaws who have no interest in being compliant with the norms of society.”
But it’s the third reason that might create the biggest obstacle. “There are others who are very much invested in the promulgation of our existing treatment models. Some because they believe, in good faith, that these are the best options we have. I also think there are some who know better, and are motivated by financial relationships tied to that model. But I don’t want to oversimplify and villainize this, because there’s plenty of room for good faith objections.”
Certainly, a lot of money is involved. Between January 1, 2017 and May 26, 2023, Kentucky Medicaid paid more than $1 billion for over 101,000,000 doses of buprenorphine, says Hubbard. The number of doses is particularly striking for a state whose population is 4.6 million people. This billing does not include “all of the bundled service charges which come with the delivery of medications for OUD services, such as the office visit, physician consult, blood draw, counseling, case management. According to broad based data, Suboxone/buprenorphine treatment has a 20% patient retention rate six months from initial intake,” he says.
Given these numbers, while $42 million may be an impressive sum for an investment in a psychedelic therapy, it is a drop in the bucket compared to the funds now committed to existing OUD treatments.
“There needs to be more discussion about what we’re doing now [to treat OUD] and that the success rate is not satisfactory,” says Ben Chandler, the former Democratic Congressman. “Especially considering the amount of money we’re throwing at this. You’re treating opioids with opioids, you’re not breaking the cycle of addiction. The drug companies are getting rich from this, and the ROI on it is very, very poor.”
Chandler, who is currently president of the Foundation for a Healthy Kentucky, has come out in support of the ibogaine plan. The Commission vote has not been scheduled, but is likely to take place this month.