FDA Approves Psilocybin Trial for Veterans and First Responders With PTSD and Alcohol Use Disorder

A new clinical trial using a botanical psilocybin drug to treat co-occurring PTSD and alcohol use disorder (AUD) in veterans and first responders has received approval from the U.S. Food and Drug Administration.

A new clinical trial using a botanical psilocybin drug to treat co-occurring PTSD and alcohol use disorder (AUD) in veterans and first responders has received approval from the U.S. Food and Drug Administration.

The study, which is being led by Dr. Nathan Sackett at the University of Washington’s Center for Novel Therapeutics in Addiction Psychiatry, will evaluate the safety of Filament Health’s psilocybin drug candidate, PEX010. Participants will receive a single 25 mg dose of psilocybin alongside non-directive psychological support, including safety monitoring, empathetic presence, and integration therapy.

According to Dr. Sackett, this marks the first time a clinical trial will assess psilocybin-assisted therapy for individuals suffering from both PTSD and AUD—conditions that frequently overlap but often lack effective dual treatments, especially among military and emergency personnel.

“Despite significant overlap between AUD and PTSD, there is a lack of evidence-based treatment options for people experiencing both conditions, particularly among veterans and first responders, who are disproportionately affected,” said Dr. Sackett in a statement.

The trial is being funded by the State of Washington and is now enrolling participants. Results are expected by fall 2026.

Benjamin Lightburn, CEO and co-founder of Filament Health, said the company is honored to support research focused on improving mental health outcomes for those who have served their communities.

“Veterans and first responders dedicate their lives to protecting others, yet are often left behind with regard to mental health treatments,” said Lightburn. “We’re proud to contribute to this urgently needed research.”

Filament Health, a clinical-stage drug development company based in Canada, specializes in natural psychedelic medicines and is developing the first FDA-approved drug candidates derived from natural psilocybin.

Thank you for reading The Marijuana Herald! You can find more news stories by clicking here.

More articles from The Marijuana Herald:

Rhode Island Lawmakers File Bill to Create “RICare” Universal Healthcare System, Ban Premiums and Copays

Rhode Island Lawmakers File Bill to Create “RICare” Universal Healthcare System, Ban Premiums and Copays

CBD May Help Limit the “Second Wave” of Brain Damage After Traumatic Brain Injury, Study Finds

CBD May Help Limit the “Second Wave” of Brain Damage After Traumatic Brain Injury, Study Finds

CB1 Activation Helps Speed Wound Healing, Reports Study

CB1 Activation Helps Speed Wound Healing, Reports Study

Florida Senate Committee to Vote Feb. 18 on Bill Tightening Low-THC Marijuana Rules and Expanding Buffer Zones for Dispensaries

Florida Senate Committee to Vote Feb. 18 on Bill Tightening Low-THC Marijuana Rules and Expanding Buffer Zones for Dispensaries

Study: CBD Kills Rare Ovarian Tumor Cells by Targeting TRPV2 Channel and Mitochondrial Pathway

Study: CBD Kills Rare Ovarian Tumor Cells by Targeting TRPV2 Channel and Mitochondrial Pathway

Edible Hemp Film Helped Keep Freeze-Dried Berries Fresher in Storage, Study Finds

Edible Hemp Film Helped Keep Freeze-Dried Berries Fresher in Storage, Study Finds

Maryland Cannabis Industry Generates $98.9 Million in Sales in January, Prices down 12% from January 2025

Maryland Cannabis Industry Generates $98.9 Million in Sales in January, Prices down 12% from January 2025

Utah Committee Advances Bill to Allow Medical Marijuana Telehealth Recommendations, Expand Low-THC Products in Pharmacies

Utah Committee Advances Bill to Allow Medical Marijuana Telehealth Recommendations, Expand Low-THC Products in Pharmacies

New York Bill Would Let Liquor Stores Sell Low-THC Cannabis Beverages, Taxed at 9% Wholesale and 13% Retail

New York Bill Would Let Liquor Stores Sell Low-THC Cannabis Beverages, Taxed at 9% Wholesale and 13% Retail

U.S. Congress: Legislation to End Cannabis Prohibition Nationwide and Allow Expungements Gains Sponsors from Nearly 30 States and D.C.

U.S. Congress: Legislation to End Cannabis Prohibition Nationwide and Allow Expungements Gains Sponsors from Nearly 30 States and D.C.

Bipartisan Oregon Bill Would Allow Physician-Supervised Ibogaine Treatment

Bipartisan Oregon Bill Would Allow Physician-Supervised Ibogaine Treatment

Virginia Bill to Require Hospitals to Allow Medical Marijuana for Terminally Ill Patients Approved by Committee

Virginia Bill to Require Hospitals to Allow Medical Marijuana for Terminally Ill Patients Approved by Committee

Tilray Expands UK Medical Supply Network Through New Distribution Deal With Smartway Pharmaceuticals

Tilray Expands UK Medical Supply Network Through New Distribution Deal With Smartway Pharmaceuticals

Virginia House Appropriations Committee Advances Bill to Legalize Recreational Cannabis Sales 16 to 6

Virginia House Appropriations Committee Advances Bill to Legalize Recreational Cannabis Sales 16 to 6

New York Legislature Passes Bill Allowing Marijuana Dispensaries Near Houses of Worship, Sends Measure to Governor

New York Legislature Passes Bill Allowing Marijuana Dispensaries Near Houses of Worship, Sends Measure to Governor

Florida Appeals Court Upholds State’s THC Limits on Hemp Products

Florida Appeals Court Upholds State’s THC Limits on Hemp Products

U.S. Congress: Legislation to Prevent Cannabis Businesses From Taking Tax Deductions Following Rescheduling Gains 15th Sponsor

U.S. Congress: Legislation to Prevent Cannabis Businesses From Taking Tax Deductions Following Rescheduling Gains 15th Sponsor

New York Senate Committee Advances Bill Allowing Parolees and Probationers to Work in Legal Marijuana Industry

New York Senate Committee Advances Bill Allowing Parolees and Probationers to Work in Legal Marijuana Industry