BIRMINGHAM, Ala — Veterans in central and west Alabama may be eligible to participate in a new federal clinical trial testing whether psilocybin, a psychedelic compound, can help treat major depression that has not responded to standard treatments.
The Birmingham VA Health Care System and Tuscaloosa VA Medical Center are among five sites nationwide in the U.S. Department of Veterans Affairs study, called Psilocybin Intervention for Veterans Overcoming Treatment-Resistant Depression, or PIVOT.
The randomized, controlled study will examine the safety and effectiveness of pharmaceutical-grade psilocybin for veterans diagnosed with treatment-resistant major depressive disorder, including veterans who also have post-traumatic stress disorder. Birmingham is the study’s lead site, according to Compass Pathways, which is working with the VA on the trial.
The trial does not legalize psilocybin, sometimes associated with “magic mushrooms,” for public use in Alabama. It is a federally supervised research study conducted under clinical protocols, with participant screening, monitored dosing and psychological support. The VA said it continues to discourage veterans from self-medicating with psychedelics or replacing prescribed treatment with unprescribed substances.
Psilocybin is a psychedelic compound found naturally in some mushroom species. The study will use a pharmaceutical formulation rather than mushrooms or other consumer products.
Participants will receive two psilocybin dosing sessions. Before the first session, they will be randomly assigned to one of two doses under blinded conditions, meaning most people involved in the study will not know which dose a participant received. All participants will receive a 25-milligram dose during the second session, scheduled one month later, according to the study’s ClinicalTrials.gov registration.
Researchers will measure depression symptoms at two and four weeks after each dosing session and follow participants for six months. The trial will also track expected and unexpected adverse events, including their severity and possible relationship to the study drug.
The Birmingham VA East Clinic is seeking participants. Local reporting said participation includes five psychological-support visits, two dosing sessions and about 11 research visits over nine months. Participants will be paid $50 at each of 11 study milestones, up to $550 total.
Eligibility is limited. The ClinicalTrials.gov listing says prospective participants must be U.S. military veterans, age 75 or younger, with a current major depressive episode and documented lack of satisfactory response to at least two antidepressant treatments. Participants also must have a responsible adult to take them home or to lodging after psilocybin administration.
The study excludes people with a history of bipolar disorder, schizophrenia-spectrum or other psychotic disorders; certain recent substance-use disorders; severe traumatic brain injury; recent psychiatric hospitalization; and specified medical conditions that could make psilocybin unsafe. The full list of criteria is available through the federal study registration.
Lori L. Davis, a Birmingham VA Medical Center psychiatrist, is listed as the trial’s principal investigator. The other sites are in Portland, Oregon; Philadelphia; and Seattle.
VA Secretary Doug Collins said in the agency’s announcement that the study is intended to explore options for veterans whose mental health conditions have not improved with available treatments.
“Far too many Veterans are living with mental health conditions that don’t respond to available treatments,” Collins said.
The Birmingham VA Health Care System said its participation could help evaluate potential new treatment options for veterans in Alabama and elsewhere.
Veterans interested in learning about the Birmingham study can call 205-899-1273 or 205-369-3384, according to the Birmingham VA East Clinic recruitment notice.