Louisiana’s health department coordinates psychedelic-assisted therapy studies, and participating health centers follow study safety rules and may work with drug developers.
The health department coordinates studies of psychedelic-assisted therapy for opioid use and certain hard-to-treat conditions. The therapy combines medication with preparation and follow-up counseling.
Participating centers document safeguards for studies, including consent, safety plans, and qualified staff. They report progress to the health department each year.
A health center may team up with a drug developer to study ibogaine and other psychedelic medicines. The state receives at least a 2.5% royalty on net sales from covered trial-related rights.
The Louisiana Department of Health establishes an initiative to coordinate psychedelic-assisted therapy studies. The initiative focuses on studies for opioid use disorders, co-occurring substance use disorders, and treatment-resistant neurological or mental health conditions. The therapy uses medication in a controlled clinical setting, with trauma-informed preparation and follow-up psychotherapy from a qualified therapist.
Participating academic health centers document study safeguards and submit yearly progress reports. These duties apply to academic health centers participating in the program. Studies must follow a federally authorized pathway and take place at an affiliated hospital, clinic, or research unit, with required insurance and approvals. Plans must cover participant consent and privacy, screening and emergency response, drug handling, and staff training and qualifications. Centers submit progress reports by January 1 each year. The health department sends a combined report to the legislature by March 1.
An academic health center may form a drug-development group with a drug developer and pursue federal review of treatments. The provision covers groups formed by an academic health center and a drug developer to study ibogaine and other listed psychedelic medicines. The group may apply for federal trial approval, seek breakthrough therapy status, and coordinate trials with groups in other states. For covered trial-related intellectual property and commercial rights, the state receives at least a 2.5% royalty on net sales; members divide the rest under a written agreement. The royalty applies while the trials are funded and during any later period of commercialization.
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