Louisiana Senators Approve Bill To Create Psychedelic Therapy Pilot Program Funded By Opioid Settlement Dollars

Louisiana senators have approved a bill to create a psychedelic-assisted therapy pilot program, using opioid settlement dollars to fund clinical trials aimed at developing alternative treatments such as psilocybin and ibogaine.

The legislation from Sen. Patrick McMath (R) passed the Senate Health and Welfare Committee, with amendments, on Wednesday. The sponsor said he filed the measure after hearing from military veterans who “opened my eyes to this world” of psychedelics therapy that they received, helping him to realize “it was a growing movement.”

The psychedelics program would be overseen by the Louisiana Department of Health (LDH), which would be responsible for facilitating clinical trials involving substances that hold therapeutic potential. The bill says that eligible participants would include people with opioid use disorders, co-occurring substance use disorders and treatment-resistant neurological or mental health conditions.

Any studies would need to go though the federal Food and Drug Administration (FDA) investigational drug approval process. Researchers would also need to be permitted by the Drug Enforcement Administration (DEA) to conduct trials involving the Schedule I controlled substances.

Patients participating in the studies would need to go through mental and physical health screening, and researchers would also be required to develop processes that ensure safety and compliance, with adverse event reporting rules, training and licensing for therapists and policies for tracking and handling the psychedelics.

There are also specific provisions in the bill (SB 43) concerning ibogaine, with academic institutions authorized to collaborate in the clinical trials to bolster FDA approval prospects to develop prescription drugs based on the psychedelic. Researchers would also be encouraged to collaborate with institutions in other states that have similar programs in place.

If a drug is approved and developed as a result of the pilot program clinical trials, there would be a revenue sharing requirement, with 20 percent of the profits that would go to the state.

“Other states have passed similar bills to allow for clinical studies performed by universities and hospitals, and this would put Louisiana at the forefront of using these innovative medicines to treat not only our veterans, but individuals impacted by the opioid epidemic,” McMath said at Wednesday’s committee hearing.

With respect to the related laws in states outside of Louisiana, such as Texas and Mississippi, the senator described an amendment that was incorporated into his bill that would follow their models by authorizing Louisiana to participate in a national consortium for ibogaine research and drug development. If an ibogaine therapy does gain FDA approval, revenue tied to the intellectual property rights of that drug would go to the consortium (except for the 20 percent specifically earmarked for Louisiana).

McMath, who chairs the Senate committee, said there is a “tremendous opportunity” provided by the use of opioid settlement dollars to fund the program.

Last year, the senator also sponsored a resolution approved by the full chamber that called for the establishment of a task force to study and make recommendations on the potential therapeutic benefits of psychedelics for veterans.

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Meanwhile in the state, another Louisiana lawmaker recently introduced a bill to create an adult-use marijuana legalization pilot program in the state to determine whether the reform should eventually be expanded and permanently codified.

Rep. Candace Newell (D)—who has long championed legislation to end cannabis criminalization and filed a similar legal marijuana pilot program measure last session—is sponsoring what’s titled the “Adult-Use Cannabis Pilot Program Regulation and Enforcement Act.”

Getting the bill across the finish line could prove complicated in the conservative legislature, however. Newell’s earlier version of the pilot program legislation didn’t advance to enactment last year, and lawmakers that session also rejected other marijuana reform proposals such as one that would have established a tax system to prepare the eventual legalization of adult-use cannabis.

Photo courtesy of Dick Culbert.