Carilion Clinic in Roanoke, Virginia, has received a federal grant to test whether psilocybin, the psychoactive compound in so-called magic mushrooms, combined with psychotherapy can help people with cocaine addiction, Cardinal News reported on Wednesday. The initial $623,000 award from the National Institute on Drug Abuse (NIDA) could grow to $3.5 million.
The treatment is experimental. The first phase is a small pilot designed mainly to assess safety and tolerability, and psilocybin is not approved by the FDA for any use.
The study matters because there is no FDA-approved medication for cocaine use disorder. That leaves families in the Roanoke Valley and across the country with fewer medical options than exist for opioid or alcohol addiction.
Inside the Two-Phase Carilion Study
Dr. Albert Arias, chief of addiction psychiatry at Carilion, leads the project. According to Cardinal News, the pilot will divide about 27 participants into three groups: two receiving a single dose of 25 or 40 milligrams of psilocybin, and one receiving a 5-milligram dose that serves as an active placebo. Participants will then be followed for six weeks, and the pilot is expected to last about two years.
The active placebo addresses a known research problem. People can often tell whether they received a psychedelic because of its noticeable effects, which can skew results, so a low dose helps keep participants less certain about their group.
A second phase would begin only if the pilot data show that participants reduced their cocaine use and NIH releases more funding. That trial would enroll about 90 people, give two doses about a month apart, and add brain imaging where possible, according to Cardinal News.
"Our goal is not to assume that psilocybin works, but to ask the question carefully, scientifically and safely," Arias said in a Carilion announcement of the award. He told Cardinal News that researchers have theories about how psilocybin might act on the brain, including by increasing its ability to form new connections, but do not yet know how it would work in addiction.
A Gap in Addiction Treatment
Cocaine acts on the brain's reward system and disrupts chemical signaling. Arias said its effects can reach down to which genes are switched on or off, which helps explain why cocaine and methamphetamine addiction have been especially hard to treat with medication.
Counseling-based treatments remain the backbone of care, and they help many people. These include programs that reward people for negative drug tests, but many people still struggle to stay in recovery.
The Carilion study reflects a broader federal push. President Trump signed an executive order in April directing the Department of Health and Human Services to speed up research and drug development involving psychedelics for serious mental illness. "Psychedelics have been enjoying a renaissance of interest in the scientific world as a treatment for psychiatric disorders," Arias told Cardinal News.
Interest is wide. More than 300 studies involving psilocybin are listed on ClinicalTrials.gov, and MedicalDaily recently reported on an FDA hearing where veterans and doctors urged safety standards for psychedelic therapy.
Evidence Limits and Who Can Join
A pilot of about 27 people cannot show whether psilocybin works for cocaine addiction. It is designed to answer whether the doses are safe and tolerable and whether there is enough of a signal to justify a larger trial. Even a positive second phase would be an early step toward any FDA review. Psilocybin also remains a Schedule I controlled substance under federal law.
Carilion plans to recruit from the broader community, not just its own patients. Eligible participants must currently meet criteria for cocaine use disorder and have used cocaine within the past month. People already in treatment may qualify if they are still struggling. Those who are interested can ask their current provider about a referral or contact Carilion directly. Psychedelic trials typically screen participants for heart and psychiatric conditions before any dose is given.
The study is an option, not a replacement for care. People who join still need ongoing support, and anyone who does not qualify can seek evidence-based counseling and treatment now.
People who use cocaine should not try psilocybin on their own. Mushrooms bought outside a study have unknown strength and possible contaminants, and research settings include medical screening, supervision, and therapy that informal use lacks. Anyone with a heart condition, a history of psychosis, or other serious health problems faces added risks.
Help is available now. The SAMHSA National Helpline at 1-800-662-4357 offers free, confidential treatment referrals 24 hours a day. Chest pain, seizures, severe agitation, or a very high body temperature after cocaine use require emergency care, so call 911 right away.
The Carilion pilot is expected to take about two years before NIH decides on the second phase. MedicalDaily will report on enrollment, safety findings, and any published results. Until then, psilocybin for cocaine addiction should be viewed as a research question, not a treatment option.
Key Questions Answered
What is Carilion Clinic studying? Whether psilocybin combined with psychotherapy can safely help people with cocaine use disorder reduce their cocaine use.
How big is the grant? The initial award is $623,000 from the National Institute on Drug Abuse, and total funding could grow to $3.5 million if a second phase proceeds.
Is psilocybin an approved treatment? No. Psilocybin is not FDA-approved for any condition and remains a Schedule I substance under federal law.
Who can join the study? Adults who currently meet criteria for cocaine use disorder and have used cocaine in the past month, including people who are not already Carilion patients.
Is there an approved medication for cocaine addiction? No. There is no FDA-approved medication for cocaine use disorder, and counseling-based treatments are commonly used.
Where can people get help now? The SAMHSA National Helpline at 1-800-662-4357 provides free, confidential referrals 24 hours a day.
Published by Medicaldaily.com
