Louisiana Senate Bill 43 has received significant attention, proposing a psychedelic-assisted therapy program to address opioid use disorder, co-occurring substance use, and treatment-resistant neurological or mental health conditions

The bill would establish the Psychedelic-Assisted Therapy Initiative under the Louisiana Department of Health, which would:

• Identify academic health centers that are conducting clinical studies and clinical trial-enabling studies for the use of psychedelic-assisted therapy for the treatment of opioid use disorders, co-occurring substance use disorders, and treatment-resistant neurological or mental health conditions
• Utilize the human service districts and authorities to identify eligible patients to participate in the program
• Provide information to parishes on utilizing opioid settlement funds to enroll eligible patients residing in the parish to participate in the studies or to support clinical trial-enabling studies that allow for the initiation of clinical trials that may enroll patients who reside in the parish

According to the bill, psychedelic medication would include ibogaine, ibogaine-based therapeutics, ibogaine analogs, psilocybin, psilocybin-based therapeutics, and mechanistically-similar analogs.

The bill currently requires that clinical studies be conducted under an FDA investigational new drug application, expanded access program, or other federally authorized pathway. Such studies must also be conducted on-site in a hospital, clinic, or research unit affiliated with the academic center. Furthermore, researchers must maintain a DEA Schedule I research registration and any required state-controlled substance registration.

Additionally, the bill provides information on necessary protocols, administration plans, and procedures for clinical studies to receive approval. Annual reports from each academic research health center would also be required.

Introduced in March, this bill has been referred to various committees and has undergone various debates and amendments, finally passing the House 97-0, now back to the Senate for a vote based on recent changes.