Last year, state lawmakers set aside $50 million for research into the psychoactive drug, which can treat opioid withdrawal and other mental health conditions.
AUSTIN, Texas — The State of Texas will launch its own program to research a psychoactive drug called ibogaine after it was unable to find a drug company to partner with to help develop a drug that will receive approval from the U.S. Food and Drug Administration (FDA).
Ibogaine is a plant-based psychedelic drug that has shown promise in treating post-traumatic stress disorder (PTSD), addiction, traumatic brain injuries and more. For years, people have traveled to clinics in different countries to access it.
In a joint statement on Tuesday, Texas Lt. Gov. Dan Patrick and Texas House Speaker Dustin Burrows (R-Lubbock) announced the launch of the state’s ibogaine research program, which will use $50 million the state set aside for research on the psychoactive drug that can treat opioid withdrawal and other mental health conditions. The goal of the state-backed research consortium is to develop a drug that will receive approval from the U.S. Food and Drug Administration (FDA).
Patrick and Burrows said the Texas Health and Human Services Commission determined that multiple proposals from drug companies did not meet “the law’s requirements and standards to receive state funds and begin clinical trials.”
“We intend to fund this program fully and will work in partnership with our great medical research teams in Texas to conduct the research,” Patrick and Burrows said in a statement.
Katharine Harris, a Fellow in Drug Policy at Rice University’s Baker Institute for Public Policy, said in some ways she was not surprised that the state could not find a private-sector drug company to partner with on ibogaine research.
State lawmakers set several requirements that companies had to meet. They needed to propose a feasible plan to develop ibogaine and obtain FDA approval, establish a corporate presence in the state, match the $50 million state investment, and agree to allow the state to receive at least 20% of the future sales of the drug.
“That may have been somewhat of a demanding ask in this research area, which is relatively high risk in terms of both the regulatory environment and also the scientific and medical side of it,” Harris said. “I think it’s not all that surprising that they had some difficulty finding an applicant who met the requirements.”
“It is certainly possible that there were very few that could have met this bar, and maybe those that could have didn’t want to, but we need more information to really be able to understand that decision,” Harris said.
Harris said some companies might be cautious and averse to taking some risks after, in 2024, the FDA denied a request to approve MDMA to treat PTSD based on safety and efficacy concerns.
“I think that that decision might also be weighing on the minds of some drug developers in terms of whether they want to invest in this area,” Harris said.
Last year, state lawmakers passed, and Gov. Greg Abbott signed Senate Bill 2308, which would create a state-funded consortium to research the psychedelic drug, including hospitals, higher education institutions, drug developers, nonprofits and other stakeholders.
State leaders said it was important to include drug companies in the consortium because of their experience developing drugs and navigating the FDA approval process.
“I certainly think that the state university of the hospitals in Texas can handle the clinical research side of this,” Harris said.
State leaders said the program, which the state will fund through a $50 million appropriation from the state general revenue fund, will make Texas a global leader and hub for ibogaine research, development, treatment, manufacturing and distribution.
During committee hearings for the bill, veterans testified that the drug has helped them deal with PTSD, anxiety and depression. To access it, veterans must travel abroad to countries where it is legal, such as Mexico. Ibogaine is currently not legal in the U.S. and is considered to be a Schedule I substance.
Chase Rowland, a former Army Ranger from Fort Worth who suffered a brain injury while jumping out of a plane, said the drug has had “miracle-like effects.” Rowan was prescribed opioids to help him recover from the injury. But he became addicted, and that addiction escalated to his use of heroin and fentanyl. In 2023, he had his second car wreck while under the influence.
After 17 years of being addicted to opioids, he traveled to Mexico in August 2023 and said it changed his life. He called it the greatest gift he has ever been given.
“Ever since I used ibogaine, now, when I look at alcohol or opioids, any substance I see is pain, and I want nothing to do with any of it,” Rowland said. “This medicine is extraordinary. It’s remarkable what it did.”
A recently released Stanford University study of 30 veterans who underwent ibogaine therapy in Mexico found that they experienced significant reductions in traumatic brain injury-associated disability, PTSD, depression and anxiety.
Under SB 2308, the trials will be run through public-private partnerships with pharmaceutical companies and state research institutions. The educational institution would serve as the group’s leader and represent it to the Texas Health and Human Services Commission. The institution would handle administrative operations and be responsible for submitting proposals or requesting funding for the clinical trials.
“The way that this consortium was set up, the legislative language requires that $50 million in private matching funds,” Harris said. “My understanding is that right now, the state should not actually be able to release that $50 million in state funds without the private match.”
It is not clear exactly how the state plans to move forward. Harris said there may need to be some legislative or legal changes to the statutory requirements of SB 2308.
“They could change or alter the requirements for the private investment. There’s a lot of interest on the venture capital side and wealthy individuals who are also very interested in supporting this kind of research endeavor into hallucinogens more generally. There’s a lot of excitement about their therapeutic potential,” Harris said. “There might be other ways for the state to explore raising that money, but that would require them to go back and maybe readjust the framework that they created last legislative session.”
In December, the Texas Health and Human Services Commission selected the University of Texas Medical Branch at Galveston and UTHealth Houston to lead a collaborative two-year, multicenter research trial that will evaluate the effect of Ibogaine on patients who have an addiction, traumatic brain injury, and other behavioral health conditions.
“This landmark clinical trial reflects our unwavering commitment to advancing research that improves lives and delivers the highest standards of care,” Melina Kibbe, MD, UTHealth Houston president and Alkek-Williams Distinguished Chair, said in a statement when the news was announced. “By joining forces with outstanding partners across our state, we are building on Texas’s tradition of innovation to ensure patients struggling with addiction and behavioral health conditions have access to the best possible outcomes. Together, we are shaping discoveries that will serve Texans and set a model for the nation.”
Harris said that without a private-sector partner, the state will likely have to find additional funding, because the journey to FDA approval will not be cheap.
“The kind of drug development process certainly requires more than 50 million, and it likely would require more than 100 million to get all the way up to the FDA approval stage,” Harris said.
Harris said we are still a while away from the clinical trial recruitment stage.
“The question goes back to the funding mechanism, and so if the state is going to fund it, how much are they going to fund it?” Harris said. “Where is the money going to come from? How are we going to make all of this a legally compliant program?”
The consortium has the backing of former Texas Gov. Rick Perry, who has, in recent years, become one of the highest-profile advocates for the study of psychedelic drugs for the treatment of PTSD in veterans.
He spoke at a panel on Ibogaine at South by Southwest last month and spoke about the mental health benefits of the psychedelic drug.
He said ibogaine advocates were able to get that done because veterans shared their success stories with lawmakers.
“We focus on the veterans because the veteran population is a very sellable population to go to the legislature with and to say, these men and women have put their lives on the line and we have failed them and come on Texas, step up to the plate here and do what you know is right and pass this legislation through a very conservative legislature,” Perry said.
Former Gov. Perry is part of an organization called “Americans for ibogaine.” They’re focused on getting more states beyond Texas involved in Ibogaine research and getting an FDA drug development trial for ibogaine.