The U.S. Food and Drug Administration approved new clinical trials for two hallucinogenic substances after the drugs showed promise in experiments involving patients with depression, post-traumatic stress disorder and other mental health problems.
Researchers are investigating the safety and effectiveness of MDMA, more commonly known as Ecstasy, in combination with psychotherapy for the treatment of post-traumatic stress disorder. Others are experimenting with psilocybin, the psychedelic chemical in mushrooms, for treating depression and anxiety in cancer patients.
Both experimental treatments are used under the supervision of therapists in controlled clinical settings. They are not being investigated as stand-alone treatments.
The MDMA trials have been sponsored by the nonprofit Multidisciplinary Association for Psychedelic Studies (MAPS). The studies support the theory that MDMA can be a complement to traditional therapy in patients who do not respond to therapy alone.
The most common forms of therapy for PTSD include cognitive behavioral therapy and eye movement desensitization and reprocessing therapy. Both therapies help patients understand and reprocess traumatic memories.
In a video sponsored by MAPS, one of the first MDMA clinical trial participants, Rachel Hope, said she tried different therapies for about 20 years to resolve symptoms of PTSD.
“The first eight-hour session I had with MDMA-assisted psychotherapy, I immediately had a reduction of symptoms that was obvious,” Hope said.
Other patients have also reported rapid improvements with the new therapy. People with chronic PTSD often require several weeks or months of traditional therapy.
“With MDMA, we’re really offering a very short-term treatment that requires only taking a medicine two or three times,” therapist Marcela Ot’alora said in the MAPS video.
MAPS is planning an FDA-approved phase III clinical trial that will involve more than 200 participants. If the results of the study are promising, the FDA could approve the drug as early as 2021, according to The New York Times.
“I’m cautious but hopeful,” Dr. Charles R. Marmar, a leading PTSD researcher at New York University, told The New York Times. “If they can keep getting good results, it will be of great use. PTSD can be very hard to treat.”
Clinical trials involving psilocybin are in earlier phases. A pair of small studies published in December 2016 showed promise.
In a trial involving 29 cancer patients with anxiety, participants reported less hopelessness and demoralization and improved spiritual well-being and quality of life after receiving psilocybin in combination with therapy. Six and a half months later, between 60 and 80 percent of patients continued to exhibit clinically significant improvements.
A separate trial of 51 terminally ill cancer patients found that large doses of psilocybin taken with behavioral therapy were associated with decreased symptoms of depression and anxiety. About 80 percent of participants continued to exhibit positive outcomes six months after the study began. Both studies were published in the Journal of Psychopharmacology.
Neither MDMA nor psilocybin is expected to receive commercial success from pharmaceutical companies because the patents on the drugs have expired. Additionally, patients undergoing MDMA-assisted therapy take the drug only between one and three times. Therapy involving psilocybin included only a single dose.
Because the drugs are taken on a short-term basis and therapy is always under doctor supervision, the risk for addiction is minimal. The clinical trials have not reported unexpected adverse events.
The researchers investigating MDMA and psilocybin had to receive approval from the DEA because both drugs are Schedule I controlled substances. They were outlawed decades ago, and they’re commonly associated with partying, music festivals and dance clubs.
On the street, Ecstasy is often combined with other harmful substances and sold in pill form. It’s been associated with numerous overdose deaths in recent years, including two at a Tampa festival in August and three at a California festival in November.
Ecstasy researcher Andrew Parrott told The New York Times that using the drug to treat mental health problems could open the door to widespread use, similar to the opioid epidemic.
“It sends the message that this drug will help you solve your problems, when often it just creates problems,” Parrott said.
The opioid epidemic began when cancer specialists were seeking a way to relieve chronic pain among terminally ill patients. The marijuana legalization movement also began as a way to treat rare forms of cancer, Dr. William Breitbart told The New York Times.
“Medical marijuana got its foot in the door by making the appeal that ‘cancer patients are suffering, they’re near death, so for compassionate purposes, let’s make it available,’” Breitbart said. “And then you’re able to extend this drug to other purposes.”
Other experts worry that increasing access to the drugs for medicinal purposes will encourage individuals with psychiatric disorders to self-medicate with street drugs in unsafe settings.
Opponents also argue that the psilocybin clinical trials involved patients with recent cancer diagnoses who hadn’t had time to naturally cope with their emotions before receiving therapy. They argue that the therapy may not have been necessary.
Those factors, in addition to the results of future large-scale clinical trials, are what the FDA will consider when determining the safety and effectiveness of the drugs in the future. For now, research continues.