Retired Army Sgt. Jonathan Lubecky couldn’t get his year out of his head in Iraq.
Loud noises and people carrying backpacks would trigger flashbacks, and he would regularly wake up from nightmares in a cold sweat. He attempted suicide five times between 2006 and 2013.
Fearing that his next suicide attempt might be successful, Lubecky signed up to take part in a clinical research study to find out if MDMA, commonly known as Molly or Ecstasy, could help tame the symptoms of post-traumatic stress disorder.
“I thought it would be fun to do and might help for a month or two,” said Lubecky, 45. “I was wrong. It’s a——miracle.
The success of treating PTSD patients like Lubecky is catapulting MDMA and other psychedelics into the medical spotlight as promising therapeutic tools. Long stigmatized, MDMA is shown to be effective in relieving PTSD in rigorous clinical trials conducted at UC San Francisco and other respected medical centers around the world.
Although some scientists remain skeptical, a growing number of researchers say the treatment could potentially help the more than 300 million people worldwide who suffer from psychiatric disorders.
“MDMA allows you to access these really deep traumatic memories in a way that doesn’t induce anxiety,” said Jennifer Mitchell, a UCSF neuroscientist who recently led a groundbreaking study of therapy-assisted therapy. MDMA.
Developed in 1912 by the pharmaceutical company Merck as a precursor to a blood clotting agent, MDMA was readily available as an experimental psychotherapeutic tool in the decades that followed.
But in the 1980s, the increasing recreational use of the drug, particularly at late-night raves, led the United States Drug Enforcement Administration to classify it as a Schedule I controlled substance – a drug determined as having no accepted medical use and a high potential for abuse. Reclassification in 1985 immediately drove legitimate studies into the therapeutic value of the chemical underground.
In an effort to prove that the drug had clear benefits, proponents created MAPS, the Multidisciplinary Association for Psychedelic Studies, in Santa Cruz the following year. The association has since expanded its research into other drugs, including LSD and marijuana, and recently moved to San Jose.
Currently, the only drugs approved for PTSD are Zoloft and Paxil. But response rates of PTSD patients to the two widely prescribed antidepressants rarely exceed 60%, and fewer than 20-30% of patients become clear of the diagnosis, according to a 2008 study. review of studies evaluating the effectiveness of both drugs in the treatment of PTSD.
New status
The psychiatric disorder, however, may have met its match. In 2017, the United States Food and Drug Administration granted MDMA-assisted therapy “breakthrough” status as a treatment for PTSD. The new status promotes a faster FDA review process because it joins a class of drugs that the agency has determined “demonstrate substantial improvement over available therapy.”
On November 22, 2014, eight years to the day after Lubecky returned from Iraq, he entered therapyy chamber in a clinical trial at the Medical University of South Carolina.
For years, Lubecky, who lives in Washington, DC, had taken a generic version of Zoloft without success. And he was initially skeptical of MDMA ability to relieve symptoms. As a child, he watched his older brother abuse drugs, so Lubecky avoided psychedelics. He also feared that a bad experience would precipitate flashbacks and cause him to become violent.
Despite the apprehension, he nervously swallowed a pill containing 125 milligrams of MDMA. After almost an hour, the drug took effect.
“I felt universal pressure all over my body,” Lubecky said. “It was a bit like wearing a wetsuit in hot water.”
Two therapists then led him through a conversation about his time in Iraq, starting with simple questions like, “What was the weather like?” As the session progressed, the therapists asked more difficult questions, focusing on the details and emotions that accompanied her traumatic experiences.
He cycled between chatting with therapists and listening to soothing music for the next six and a half hours, pausing only for a booster dose of 68 milligrams of MDMA two hours into the session.
Prior to enrolling in the clinical trial, Lubecky said, his previous 50-minute therapy sessions were too short to delve into meaningful topics — and he would either become too upset to speak or completely block out emotions.
In contrast, he added, MDMA stabilized his emotions and helped him trust his therapists. “My body didn’t go haywire when I was talking about these things,” he said.
He repeated the MDMA-assisted therapy session twice over the following winter and spring, along with continued traditional therapy. After completing the clinical trial, Lubecky’s suicidal thoughts, depression, panic attacks and inability to trust people gradually dissipated. And he was resilient in the years that followed.
Studies continue
Mitchell of UCSF is now building on the success of the Phase 2 study in which Lubecky and 25 other patients participated. She recently led a phase 3 trial that involved 90 patients at 15 research sites in the United States, Canada and Israel. It’s the first psychedelic-assisted therapy to make it this far down the FDA’s regulatory pipeline.
Mitchell and colleagues found that after two months of treatment, 67% of those who received MDMA with therapy were no longer diagnosed with PTSD, compared to 32% in the group who received therapy and a placebo.
The study, funded by the Multidisciplinary Association for Psychedelic Studies, has been published last May in the prestigious journal Nature Medicine. And if researchers are able to replicate this finding, the treatment could gain FDA approval as early as next year.
“It was long to come, and we have been studying PTSD as a group for many, many years,” Mitchell said. “So it’s nice to think that we may have identified a therapeutic that actually has some relevance.”
MDMA works by reducing activity in the amygdala, the brain fear processing center and increased activity in the prefrontal cortex, according to Rick Doblin, founder and executive director of MAPS.
Doblin, co-author of the phase 3 study, itsid the drug allows the patient to think more logically without fear. Additionally, he said, the drug improves connectivity between the amygdala and hippocampus, which helps patients process their traumatic memories and place them in the past.
“MDMA has a variety of effects in the brain,” Doblin said. “You could say it changes the brain in the opposite way that PTSD changes the brain.”
The drug also triggers the release of the hormones serotonin, dopamine, norepinephrine, and oxytocin. Serotonin, in particular, promotes feelings of social connection, empathy and trust. In a therapeutic setting, it can help strengthen the patient-therapist relationship, said Dr. Boris Heifets, an anesthetist at Stanford University School of Medicine who studies the effects of psychedelics in rodent models.
The setting also influences the effects of MDMA, according to Heifets. If it’s taken at a rave, for example, “it’s almost not even the same drug as when you take it as part of therapy,” he said.
The treatment could be particularly helpful for veterans and people with complex trauma, like patients in the Phase 3 study. The therapy could also help sexual assault survivors, who Lubecky says make up the vast majority of research participants in MAPS studies, but receive little media attention.
“Veterans have a voice to speak out about PTSD in ways that others cannot,” he said.
Concerns Raised
However, the revival of research around MDMA, in particular the the Mitchell study involves some academics and clinicians.
“I’m a bit skeptical of how they present their findings and basically the hype surrounding MDMA-assisted therapy,” said Joar Øveraas Halvorsenclinical psychologist at the Norwegian University of Science and Technology in Trondheim, Norway.
Halvorsen and some of his colleagues claim that MDMA-assisted therapy has not been compared to existing treatments for PTSD or tested on enough people to adequately measure the drug’s potential adverse effects, including heart abnormalities, abuse potential, and increased suicidal thoughts. The Norwegian scientists also argue that the therapy can work simply because the sessions are much longer than traditional ones.
Research on MDMA, meanwhile, extends beyond its effects on people with PTSD. Scientists are also studying its therapeutic value for eating disorders, alcohol abuse, social anxiety in autistic adults, anxiety associated with life-threatening illnesses and other difficult-to-treat disorders.
Regarding fears that people with PTSD abuse the drug, Lubecky said that after completing MDMA-assisted treatment, he would never turn to MDMA for a fun night out.
“It wasn’t a fun experience – it was a lot of very, very difficult and hard work,” he said. “I’ve been through all the worst things I’ve been through in my entire life.”
Today, Lubecky said, he enjoys his job as a political strategist and liaison with MAPS veterans. He also enjoys providing pro bono counseling to veterans with PTSD seeking help.
Without MDMA-assisted therapy, he said, his teenager son-in-law would have lost a father.
“I have a great life,” Lubecky said. “I wouldn’t even be alive right now if it wasn’t for this.”
