Larry Leeman, MD, MPH, who treats expectant mothers experiencing opioid use disorder as medical director for The University of New Mexico’s Milagro Program, was dismayed to see that many of his patients eventually resumed opioid use due untreated post-traumatic stress disorder (PTSD).
Now, Leeman and his colleagues are launching a first-of-its-kind pilot study to see whether a regimen of trauma-focused therapy coupled with doses of MDMA – popularly known to rave participants as ecstasy or molly – can help new mothers permanently overcome their drug dependency.
The FDA-approved open label study will enroll 15 people with diagnoses of moderate to severe PTSD six to 12 months after they have given birth. Each participant will receive 12 weeks of intensive therapy and three medication sessions, Leeman said. The project, funded through private donations, will assess whether MDMA-assisted therapy can help the mothers overcome their addictions and improve bonding with their infants.
What the MDMA-assisted therapy does is take away their fear for a short period of time. During that time, they have the ability to process the trauma that has led to their PTSD and which have never been able to process.
Leeman’s team is collaborating with the Multidisciplinary Association for Psychedelic Studies, which is supplying the MDMA used in the pilot. He noted that when the MDMA is purchased on the street it is often dangerously adulterated with other drugs, such as methamphetamine.
MDMA has complex effects, including some that are similar to classic psychedelics, such as psilocybin, which tamps down the brain’s default mode network and may interrupt trauma-driven rumination. In addition, MDMA temporarily increases production of oxytocin, a hormone that promotes a sense of connectedness, Leeman said.
“Addiction has been described as the opposite of ‘connection,’” Leeman said. “Another proposed mechanism of psychedelic-assisted therapies for addiction is that they increase participants’ connections with self, including emotions, values and life meaning, connection to others – family and community – and connection to the world and universe, which includes connection with nature and the feeling that everything is interconnected.”
The key to treatment, he said, lies in addressing the patient’s underlying trauma.
“What the MDMA-assisted therapy does is take away their fear for a short period of time,” Leeman said. “During that time, they have the ability to process the trauma that has led to their PTSD and which have never been able to process. It’s a bit of a redo in helping people heal in ways that may improve their ability to bond with their baby.”
The study, formally dubbed, “MAT-POD Study of MDMA-Assisted Therapy 6 to 12 months After Childbirth for People with Co-Occurring Opioid Use and Post Traumatic Stress Disorders,” is part of a growing body of research into the use of psychedelic drugs like LSD, MDMA, DMT, ketamine and psilocybin to aid in the treatment of addiction, trauma, depression and death anxiety.
After decades of stigma due to their association with recreational drug use, researchers are finding these substances can facilitate dramatic improvements in symptoms when used in conjunction with therapy.
The legal landscape is starting to change as a result. In January, Oregon became the first state to legalize the adult use of psilocybin, and Colorado may be on track to follow suit. This year, New Mexico lawmakers considered a bill to fund a two-year study of the therapeutic use of psilocybin, but the legislation died in committee.
UNM scientists have played a key role in validating the therapeutic uses of psychedelics, Leeman said. In the 1990s UNM psychiatrist Rick Strassman conducted dose-response studies of DMT, a short-acting psychedelic that is the active ingredient in ayahuasca.
More recently, Michael Bogenschutz, MD, formerly a professor in the UNM Department of Psychiatry & Behavioral Sciences, published research showing that psilocybin, derived from so-called “magic mushrooms,” is an effective adjunct to therapy in the treatment of alcohol use disorder.
That work continues at UNM under the leadership of Snehal Bhatt, MD, UNM’s director of Addiction Psychiatry, who is a co-investigator of the MDMA-assisted therapy study, along with Ariele Bauers, RN, CNM, a community practitioner with dual board certification as a nurse midwife and psychiatric mental health nurse practitioner.
Leeman said he had treated thousands of expectant mothers struggling with substance use at the Milagro clinic using medications like buprenorphine and methadone to curb their craving for opioid drugs.
“Our program was very successful at helping people get through pregnancy,” he said. “However, over and over I would see them come back in a year or two having resumed use of heroin – or now, fentanyl.”
“I thought, ‘I don’t think I’m actually getting at the heart of this for a lot of people,’” he said. Leeman came to realize that PTSD resulting from childhood physical and sexual abuse, as well as domestic violence, was driving the addiction cycle. “I started looking at what might help with the trauma, and that led me on the path to MDMA-assisted therapy.”
A recent Phase 3 study found MDMA-assisted therapy to be effective in treating moderate to severe PTSD, with about 70% no longer meeting criteria for PTSD after receiving the treatment, he said. The study found it to be more effective than existing SSRI antidepressants in eliminating PTSD symptoms.
Leeman went on to spend a sabbatical at the California Institute of Integral Studies and the University of Wisconsin – Madison addiction medicine program to gain expertise in providing MDMA- and psilocybin-assisted therapy.
The new study, which will get underway at UNM in the next few months, will recruit a diverse group of patients, who have remained stabilized on their current medications.
The therapy sessions will be conducted at the newly opened Interdisciplinary Substance Use and Brain Injury building on UNM’s North Campus, Leeman said. The facility has state-of-the-art capabilities for psychedelic research and allows for the overnight stays mandated by the FDA in the study of MDMA.
The UNM Foundation has established a fund for donors who are interested in supporting this research.