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Texas Gov. Greg Abbott (R) has signed into law a bill to create a state-backed research consortium to conduct clinical trials on ibogaine as a possible treatment for substance use disorders<\/a> and other mental health conditions. The ultimate goal of the project is to develop the psychedelic into a prescription drug with U.S. Food and Drug Administration (FDA) approval, with the state retaining a portion of the profit.<\/p>\n \u201cTexas is now leading the way in the United States for the evaluation of ibogaine as a potential medication that can help improve the lives of so many Americans,\u201d the governor said at a signing event on Wednesday. He called the psychedelic \u201ca therapy that has shown great promise in treating\u201d conditions such as depression, PTSD and opioid use disorder.<\/p>\n \u201cI\u2019m about to sign a law that will lead to an FDA-approved drug development clinical trial that will seek approval of ibogaine as a medication for the treatment of opioid use disorder and other behavioral health conditions, especially those suffered by our veterans,\u201d he added. \u201cTexas will invest $50 million to support this research, and these funds can be matched by grants and private investments.\u201d<\/p>\n Under the new law, approved by the state legislature earlier this month, Texas will retain a commercial interest in \u201call intellectual property that may be generated over the course of the drug development clinical trials,\u201d the legislation says, with an aim of making Texas a hub for \u201cibogaine-related biomedical research, development, treatment, manufacturing, and distribution.\u201d<\/p>\n A quarter of revenue taken in by the state from any resulting intellectual property would fund veterans programs.<\/p>\n House Speaker Dustin Burroughs (R) said at the event that while he knew little about ibogaine before the session began, lawmakers \u201cheard story after story\u201d from people who said the therapy had improved their lives.<\/p>\n \u201cIt made an impact,\u201d he said, \u201cand slowly, as session went on, the members of the Texas House, members of the Senate, began to agree that this was worth the next step. It was worth investing in and\u2026seeing if we could do something to bring this to more people.\u201d<\/p>\n Bill sponsor Sen. Tan Parker (R) said the new law \u201cis about the opportunity to restore the lives of so many veterans that have put their lives on the line for all of us.\u201d<\/p>\n \u201cWe\u2019re incredibly excited to take this step. There\u2019s nothing more important than protecting our veterans and our public at large,\u201d Parker said. \u201cThis will have benefits for everyone if the clinical trial is successful, as we believe it will be.\u201d<\/p>\n As for what happens next, he said that \u201cwithin 60 days,\u201d the state is expected to start receiving proposals from institutions and organizations to be part of the consortium.<\/p>\n \u201cThe money that Texas is investing will only be put in based on a match, based on private funds being contributed by people that have great expertise,\u201d he continued. \u201cSo we\u2019re looking forward to that consortium\u2026coming forward, and again, we\u2019ll be receiving those proposals 60 days from now.\u201d<\/p>\n Along with the legislation\u2019s goal of winning FDA approval as a clinical treatment, the bill says it also seeks \u201ca breakthrough therapy designation for ibogaine\u201d\u2014a designation FDA gives to emerging treatment options that haven\u2019t yet secured agency approval to treat a particular condition.<\/p>\n After the House and Senate passed separate versions of the measure<\/a>, it was amended by a bicameral conference committee. The compromise legislation passed the Senate on a 26\u20135 vote and the House 134\u20134.<\/p>\n Rather than create a state grant program to support research on the psychedelic,\u00a0as previous forms of the bill would have done<\/a>, the compromise version of the bill establishes a \u201cconsortium\u201d\u2014including an institution of higher education, a hospital and a drug developer\u2014to develop and test ibogaine drugs in an effort to secure FDA approval.<\/p>\n The educational institution would serve as the consortium\u2019s leader, representing the group to the state Health and Human Services\u00a0 Commission (HHSC) and handling administrative functions. It would further be responsible for submitting \u201ca proposal and request for funding on behalf of the consortium for purposes of conducting ibogaine drug development clinical trials in accordance with this subchapter.\u201d<\/p>\n \u2014 The program is set to be funded through a $50 million appropriation from the state general fund, which would go to HHSC for disbursement to cover the drug development trials, according to a conference committee report for SB 1<\/a>, a massive state budget bill. Private gifts, grants and donations would also be accepted.<\/p>\n \u201cInitially, no state funding was appropriated for the initiative,\u201d sponsor Parker explained to colleagues earlier this month. \u201cHowever, that has now changed.\u201d<\/p>\n A fiscal note on the final conference committee bill says HHSC will need to appropriate money \u201cto fund the consortium\u2019s clinical trials, but the cost of such funding is unknown at this time.\u201d<\/p>\n As for revenue stemming from intellectual property resulting from the research and new drug development, the analysis says the amount \u201cis indeterminate and would be dependent on the drug development trials.\u201d<\/p>\n Revenue from the project would flow into Texas\u2019s general fund, and from there 25 percent would be earmarked \u201conly to programs that assist veterans in this state.\u201d<\/p>\n Rep. Greg Bonnen (R) said on the House floor before the vote on the proposal that said \u201cthe state will have negotiated for royalties at a minimum of 20 percent.\u201d<\/p>\n Reformers have cheered the legislation. Bryan Hubbard, executive director of the American Ibogaine Initiative and an architect of the bill, said of the final version that \u201cI have to give the legislature an A across the board.\u201d<\/p>\n \u201cI think that it can stand up as a national model for other states that wish to replicate it in some form or fashion,\u201d he said in an interview with Marijuana Moment after the bill\u2019s passage in the legislature, thanking in particular sponsors Parker and Rep. Cody Harris (R) as well as House Speaker Burroughs and Lt. Gov. Dan Patrick (R), who presides over the Senate.<\/p>\n \u201cWithout the courage and vision of those four individuals, none of this would have happened,\u201d Hubbard said, \u201cand I am forever grateful to Texas leadership for making this, in my estimation, one of the greatest single achievements in the history of the of the American psychedelic movement.\u201d<\/p>\n Hubbard said at the time that he believes the state having a vested interest in intellectual property produced by the research will ensure Texans see \u201ca perpetual return on their investment.\u201d<\/p>\n \u201cMost Americans, I believe, have had enough of public dollars going into the pockets of private corporations with no return on investment for the taxpayer,\u201d he said. \u201cWith the way in which Texas has set this project up, Texas taxpayers are going to be fully vested partners in this endeavor, and the people of Texas will see\u2014if we are successful\u2014perpetual return on their investment that will hopefully be used to assure universal treatment access through a top-notch, ibogaine-based treatment and recovery system as time and circumstances evolve.\u201d<\/p>\n An earlier analysis of the legislation said that opioid use disorder (OUD)\u00a0\u201ccontinues to be one of the most insidious threats to public health of our time, devastating individuals, families, and communities across Texas and our nation,\u201d and \u201ccurrent treatment options are often unsuccessful in treating OUD and lives are lost as a result.\u201d<\/p>\n Hubbard noted that the new Texas plan is similar to\u00a0an ibogaine research proposal a few years ago in Kentucky<\/a>\u00a0that he also helped design. That bill would have distributed at least $42 million in funding for research into ibogaine\u2019s potential to treat opioid addiction.<\/p>\n The effort fell through in late 2023 after the state\u2019s new attorney general replaced Hubbard, who was then serving as chair of the Kentucky Opioid Commission, with a former Drug Enforcement Administration (DEA) official.<\/p>\n Last year\u00a0advocates tried to enact a similar plan in Ohio<\/a>.<\/p>\n \u201cThe legislation that you see is the Kentucky plan as implemented by the state of Texas,\u201d Hubbard said. In terms of the consortium, the way that they have set this up is to create a cooperation framework on the front end that I had always envisioned occurring on the back end.\u201d<\/p>\n \u201cWhen this program was designed for Kentucky, I had in mind that we would essentially send out an RFP [request for proposals] for a drug developer, send out an RFP for a trial site, and to pick the best. And to pair the drug developer with trial science on the back end,\u201d he explained.<\/p>\n \u201cIn the Texas framework, this is a cooperative partnership that will have to be built on the front end by those who want to be able to pursue this opportunity,\u201d Hubbard continued. \u201cThere is a role for both universities and private hospitals, which is important because they each have significant things to contribute.\u201d<\/p>\n HHSC will retain control over the consortium, he said, \u201cand the reason that that legal authority needs to be there is because you want the absolute best drug developer and you want the absolute best aggregation of trial sites within Texas, who can make sure that these trials are done safely, efficiently and effectively.\u201d<\/p>\n Meanwhile in Texas, a new statewide poll finds that Republican primary voters oppose a separate proposal to ban hemp products containing THC<\/a> that lawmakers recent sent to the governor\u2019s desk.<\/p>\n While Abbott has declined to say how he\u2019ll act on SB 3<\/a>\u2014which advocates and stakeholders say would decimate the state\u2019s hemp industry\u2014the policy change evidently isn\u2019t being embraced by voters, including a plurality of Republicans (47 percent) who voiced opposition, said the survey, from Ragnar Research Partners and commissioned the Texas Hemp Business Council (THBC).<\/p>\n Military veterans advocates, including\u00a0Texas Veterans of Foreign Wars, have called on the governor to veto the hemp ban<\/a>, saying it \u201cwould cause irreversible harm to communities across the state.\u201d<\/p>\n Farmers have also said the prohibition would\u00a0devastate a key sector of the state\u2019s agriculture industry<\/a>.<\/p>\n Last month, the Texas House also passed a pair of bills designed to ensure speedy access to psychedelic-assisted therapy<\/a>\u00a0in the event of FDA approval, but they did not clear the Senate by the end of the session.<\/p>\n More recently, lawmakers passed a bill to\u00a0significantly expand the state\u2019s medical marijuana program<\/a>, sending it to the governor.<\/p>\n The measure would expand the state\u2019s list of medical cannabis qualifying conditions to include chronic pain, traumatic brain injury (TBI), Crohn\u2019s disease and other inflammatory bowel diseases, while also allowing end-of-life patients in palliative or hospice care to use marijuana.<\/p>\n Separately, a House committee approved a Senate-passed bill last month that would prohibit cities from putting any citizen initiative on local ballots that would decriminalize marijuana<\/a>\u00a0or other controlled substances\u2014as several localities have already done despite lawsuits from the state attorney general.<\/p>\n Under the\u00a0proposal, state law would be amended to say that local entities \u201cmay not place an item on a ballot, including a municipal charter or charter amendment, that would provide that the local entity will not fully enforce\u201d state drug laws.<\/p>\n While several courts have\u00a0previously upheld local cannabis decriminalization laws<\/a>, an appellate court comprised of three conservative justices appointed by the governor has recently pushed back against two of those rulings, siding with the state in its legal challenge to the marijuana policy in\u00a0Austin<\/a>\u00a0and\u00a0San Marcos<\/a>.<\/p>\n Despite the ongoing litigation and advancement of the House and Senate bills, Texas activists have their targets set on yet another city, Kyle, where\u00a0they hope put an initiative before voters to enact local marijuana reform<\/a>\u00a0at the ballot this coming November.<\/p>\n A recent poll found that\u00a0four in five Texas voters want to see marijuana legalized in some form<\/a>, and most also want to see regulations around cannabis relaxed.<\/p>\n GOP-Led Congressional Panel Demands Investigation On Biden\u2019s Marijuana Rescheduling Process, Citing \u2018Deviations\u2019 And \u2018Mental Health Hazards\u2019<\/a><\/p>\n<\/blockquote>\n\n Photo courtesy of Flickr\/Scamperdale<\/a>.<\/em><\/p>\n The post Texas Governor Signs Psychedelics Bill Aimed At Developing Ibogaine Into An FDA-Approved Drug<\/a> appeared first on Marijuana Moment<\/a>.<\/p>\n
Texas Gov. Greg Abbott (R) has signed into law a bill to create a state-backed research consortium to conduct clinical trials on ibogaine as a possible treatment for substance use disorders and other mental health conditions. The ultimate goal of the project is to develop the psychedelic into a prescriptionContinue Reading<\/a><\/span><\/p>\n","protected":false},"author":24,"featured_media":81621,"comment_status":"false","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[18,81,126],"tags":[],"_links":{"self":[{"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/posts\/81620"}],"collection":[{"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/users\/24"}],"replies":[{"embeddable":true,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/comments?post=81620"}],"version-history":[{"count":1,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/posts\/81620\/revisions"}],"predecessor-version":[{"id":81622,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/posts\/81620\/revisions\/81622"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/media\/81621"}],"wp:attachment":[{"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/media?parent=81620"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/categories?post=81620"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/tags?post=81620"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
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\nRead More: Texas Governor Signs Psychedelics Bill Aimed At Developing Ibogaine Into An FDA-Approved Drug<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"