Photo: UMass Chan Medical School
A clinical trial at UMass Chan Medical School is evaluating whether an investigational psychedelic medication can help people experiencing adjustment disorder after being diagnosed with a serious medical condition.
The study will evaluate whether the lab-made chemical 4-OH-DiPT can improve symptoms of adjustment disorder in people with cancer, amyotrophic lateral sclerosis (ALS), multiple sclerosis, Parkinson’s disease or idiopathic pulmonary fibrosis. This chemical acts similarly to psilocybin, the active ingredient in certain mushroom species.
The study is being led by Anthony Rothschild, MD, the Irving S. and Betty Brudnick Chair in Psychiatry and professor of psychiatry & behavioral sciences, and brings together clinicians and researchers across multiple departments, including psychiatry, medicine and neurology.
Adjustment disorder can occur when a person experiences significant emotional or behavioral symptoms in response to an identifiable stressor, such as divorce, job loss or a serious medical diagnosis. Symptoms may include sadness, overwhelming worry or fear, loss of interest in daily activities, withdrawal from friends and family, difficulty sleeping or concentrating and feelings of hopelessness about the future.
“There are no FDA-approved treatments for adjustment disorder,” said Dr. Rothschild. “This study is part of a long history of research exploring the potential use of psychedelic medications to help people. Some of the earliest studies of psychedelics examined their potential use among people with cancer experiencing significant psychological distress.”
While adjustment disorder can develop in response to a range of life events such as a divorce or loss of a job, the study focuses on people whose symptoms occur in the context of a serious medical illness.
The investigational medication in the study will be administered through a single subcutaneous injection, meaning it is delivered just under the skin. The medication is designed to be absorbed relatively quickly and to travel across the blood-brain barrier. Its effects are expected to last approximately three to four hours.
Researchers will evaluate the drug’s impact on the participant’s emotional state and mood one week after dosing and will continue to follow participants for six weeks post treatment. The study has begun enrolling participants, primarily from the UMass Memorial Health patient population.
The study will take place in a highly controlled clinical setting due to the potential side effects of the drug. A trained monitor will remain with participants throughout the dosing experience, and a physician trained in advanced life support will be available nearby. Participants will be closely monitored for potential psychiatric and medical side effects during dosing and throughout the follow-up period.
While the medication’s immediate effects are expected to diminish after several hours, participants will remain at the study site for additional observation and return for weekly evaluations over the six-week follow-up period.
The trial builds on UMass Chan’s growing research into psychedelic medications, including research involving psilocybin for treatment-resistant depression.
Additional studies will be needed to determine whether the drug’s effects extend beyond that initial six-week timeframe.
“The first step is just to see if it works and if it lasts six weeks,” said Rothschild. “There’ll be other studies that need to be done to see if it lasts longer.”
