Researchers at The University of Texas Health Science Center at San Antonio and their collaborators at Emory University have received a $4.9 million grant aimed at significantly improving treatment and recovery rates for individuals suffering from post-traumatic stress disorder.
The project was recently selected for funding by the U.S. Department of Defense through a call for studies to evaluate psychedelics as a treatment for PTSD in hopes of pushing the field forward. In this effort, the innovative clinical trial will use 3,4-methylenedioxy-methamphetamine hydrochloride, or MDMA, commonly known as ecstasy, in combination with a leading psychotherapy for PTSD called Prolonged Exposure.
Prolonged Exposure therapy for PTSD works by helping individuals process traumatic memories and feelings while recalling them in a safe environment. The goal of the new study is to capitalize on beneficial MDMA properties in a synergistic way to enhance Prolonged Exposure's efficacy, hopefully leading to greater symptom reductions and more patients being treated into remission.
The trial's lead investigator is Alan Peterson, PhD, professor of psychiatry and behavioral sciences at UT Health San Antonio and director of the STRONG STAR Consortium. STRONG STAR is a national research network focused on finding the best preventions and treatments for psychological health issues affecting military members, veterans, and first responders.
Cognitive-behavioral psychotherapies have the strongest scientific support for the treatment of PTSD, but for military service members and veterans, recovery rates with these treatments seem to have maximized at about 50%. Existing medications have not shown good promise when used alone, so we're looking at novel ways to enhance treatment outcomes so that more of our psychologically wounded warfighters have the chance of full recovery from PTSD."
Alan Peterson, PhD, professor of psychiatry and behavioral sciences at UT Health San Antonio
Researchers believe MDMA shows some of the greatest potential in this regard. One reason is that MDMA, in combination with psychotherapy, has demonstrated significant improvements in PTSD. It has revealed increased neuroplasticity, or the brain's ability to adapt, for about two weeks after administration, which is beneficial for therapeutic learning.
Finally, it impacts emotional memory circuits related to PTSD development and recovery. These memory circuits affect conditioned fear responses that are associated with PTSD. Researchers think MDMA will work synergistically with Prolonged Exposure to help patients process traumatic memories.
Other research support for MDMA comes from study collaborators at Emory University School of Medicine, who include Jessica Maples-Keller, PhD, Barbara Rothbaum, PhD, and Boadie Dunlop, MD.
In an ongoing, open-label pilot study by the Emory Healthcare Veterans Program, results show that one dose of MDMA significantly reduces PTSD symptoms among military members and veterans when combined with massed Prolonged Exposure (PE). In massed PE, therapy is delivered daily for two weeks instead of the standard once or twice weekly over several weeks or months, coinciding with the timeline of MDMA's therapeutic effects on neuroplasticity.
With this in mind, Peterson and his colleagues designed the new STRONG STAR trial to incorporate a single dose of MDMA early in treatment with massed PE. This two-armed, double-blind, randomized clinical trial will involve 100 active-duty military, guard and reserve personnel, including 75 recruited through UT Health San Antonio and 25 through Emory University School of Medicine.
After a first therapy session, a single dose of MDMA will be given in the second session, with therapeutic guidance from two therapists. Between the two study arms, the dosage level will differ to help researchers determine the optimal dose for therapeutic benefit while maintaining the study blind. The remaining sessions will be massed PE as usual, delivered during the two-week period that MDMA theoretically enhances neuroplasticity.
Participants will be assessed at one and three months post-treatment. Researchers expect that those receiving treatment will achieve significant reductions in PTSD symptoms, suicidal ideation and depression as well as significant increases in return-to-duty readiness, psychosocial functioning and intimate relationship functioning.
Researchers say if the treatment approach is successful, it could have a profound impact on optimizing PTSD treatment for military personnel, with a strong potential to treat service members into remission. Furthermore, it could be readily disseminated within the military and VA health care systems, where PE availability is widespread and massed PE is being rolled out as a standard of care, providing opportunity for incorporating a single MDMA dose into treatment. Other possibilities could include MDMA's incorporation into intensive outpatient treatment programs.
"We truly believe this trial provides the opportunity to make major leaps forward in PTSD treatment and potentially create a new standard of care for the field," Peterson said.
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