New York-based biotech company Biotech Inc. has launched a clinical trial in LSD treatment for anxiety. Last week, it announced that it had given the psychoactive drug to the patient who was enrolled in this study. The purpose of the research is to examine whether MM-120 from MindMed (a pharmaceutically optimized version of lysergic Acid Diethylamide) can be used in general anxiety disorder (GAD).

MindMed is a company that is developing psychotropic therapies for mental health conditions. Robert Barrow, the chief executive officer of the company, said that the study is the largest well-controlled clinical trial of LSD ever conducted, adding that the research “represents a major milestone for MindMed and for the many patients suffering from GAD.”

“This exciting next step in the advancement of LSD builds on the positive topline data presented by our partners at University Hospital Basel in May 2022, which demonstrated the rapid, durable, and statistically significant effects of LSD and its potential to safely mitigate symptoms of anxiety and depression,” Barrow said in an August 25 statement from the company. “The results of our phase 2b trial will guide the dose selection and development strategy for our pivotal phase 3 clinical trials, as we continue our efforts to bring a new potential treatment to the millions of people living with GAD.”

GAD, a debilitating and chronic mental disorder, affects almost 6% of Americans at one time or another. GAD can be described as excessive worry, anxiety, and depression that lasts over six months. These symptoms can result in significant impairments of social, occupational, and other functional functioning according to the National Institute of Mental Health. GAD and major depressive disorder (MDD), which are both serious mental illnesses, share many similarities. However, there has been little research on the treatment of the condition over the last several decades.

MindMed’s phase 2b trial is a multi-center, parallel, randomized, double-blind, placebo-controlled, dose-optimization study. Researchers plan to enroll 200 patients who receive either a single 200-microgram dose of MM-602 or a placebo. The study’s primary goal is to examine the effects of MM120 on anxiety symptoms in four weeks. This will be compared between five groups. The study’s secondary goals, which were measured for up to 12 weeks following the administration of MM-120, included assessments of safety, tolerability, and quality of life.

LSD Research is Reviving

MindMed is an example of the recent revival in research into psychoactive drugs as treatments for serious mental conditions. Michael Pollan, a journalist and educator who this summer released “How to Change Your Mind,” a Netflix documentary series based on his 2018 book with the same title, notes that researchers studied LSD as a possible treatment for mental health disorders in the 1950s and ‘60s. After people started using the drug recreationally, opinions changed.

“With a powerful assist from Timothy Leary, the flamboyant Harvard psychology professor, psychedelics had escaped the laboratory, falling into the eager arms of the counterculture,” Pollan wrote in the Wall Street Journal2018 “Yet in the decade before that there had been 1,000 published studies of LSD, involving 40,000 experimental subjects, and no fewer than six international conferences devoted to what many in the psychiatric community regarded as a wonder drug.”

LSD was made illegal in America in 1968. This effectively ended decades of research on the drug. Interest in LSD as a treatment for psychiatric disorders has increased. In July, the American Psychiatric Association published a statement encouraging further research in psychedelics to treat serious mental illnesses.

“There is currently inadequate scientific evidence for endorsing the use of psychedelics to treat any psychiatric disorder except within the context of approved investigational studies,” the APA wrote in a policy position approved by the professional group’s board of trustees. “APA supports continued research and therapeutic discovery into psychedelic agents with the same scientific integrity and regulatory standards applied to other promising therapies in medicine.”