A New York-based biotech firm has begun a clinical trial to study LSD as a treatment for anxiety, announcing last week that it had administered the psychedelic drug to a patient enrolled in the study for the first time. The research is designed to study the effectiveness of MM-120, a pharmaceutically optimized form of lysergic acid diethylamide (LSD) from MindMed, in treating generalized anxiety disorder (GAD).
MindMed is a biopharmaceutical company developing psychedelic therapies to treat mental health disorders. 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 is a chronic and sometimes debilitating mental health disorder that affects nearly 6% of U.S. adults at some point in their lives. Symptoms of GAD include excessive anxiety and worry that persists for over six months, which can lead to significant impairments in social, occupational and other functioning, according to the National Institute of Mental Health (NIMH). While there are substantial similarities between GAD, major depressive disorder (MDD) and other serious mental health conditions, research into the disorder has yielded little innovation in treatment over the past several decades.
MindMed’s phase 2b trial is a multi-center, parallel, randomized, double-blind, placebo-controlled, dose-optimization study. Investigators plan to enroll 200 participants who will receive either a single administration of up to 200 micrograms of MM-120 or a placebo. The primary objective is to determine the reduction in anxiety symptoms 4 weeks after a single administration of MM-120, compared across five groups of study participants. Key secondary objectives of the study, measured up to 12 weeks after the single administration, include assessments of safety and tolerability as well as the quality of life.
The Resurgence of LSD Research
The MindMed study is representative of the recent resurgence in research into psychedelic drugs as treatments for serious mental health 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. The tide of opinion turned against the drug only after people began using it recreationally.
“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 Journal in 2018. “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.”
In 1968, LSD was criminalized in the United States, largely ending research into the drug for decades. But interest in its value as a psychiatric medicine has rebounded. In July of this year, the American Psychiatric Association issued a statement that encouraged continued research into psychedelics as therapies for serious mental health conditions.
“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.”