Many people in Hampton Roads know the tragic reality: Post-traumatic stress disorder (PTSD) can result in suicide attempts and deaths. The disorder is difficult to treat. Right now, the only drugs approved don't actually heal the patients.
“We’ve known for a long time that although some medications can help decrease the symptoms, they aren't curative,” psychiatrist Michael Mithoefer told 13News Now.
Dr. Mithoefer and his wife, Annie, who is a nurse, have used therapy for years to help people with PTSD.
“The treatment involves revisiting the trauma and processing and bringing understanding to what's happened,” explained Mithoefer.
While psychotherapy has produced some positive results, the treatment, in and of itself, can be traumatic. For some veterans, revisiting the harsh realities of war causes overwhelming anxiety. For others who've shut down much of their emotions, the therapy isn't effective.
The Mithoefers, who lead the Charleston study site for the federal trial, said MDMA has been successful with this patient population.
“It gives people a period of time when there's less fear,” Mithoefer stated.
The drug decreases activity in the fear center of the brain and increases activity in the brain's processing center. As a result, the people don't feel the fear, which normally prohibits them from facing their memories. At the same time, they are able to process what happened more clearly.
Mithoefer and Annie took us through how the study (which the nonprofit group MAPS spearheads) works.
In addition to regular psychotherapy sessions, there are three times when participants randomly are given MDMA or a placebo during their inpatient therapy session. The patient doesn't know which one he/she received.
Participants are monitored at the study site for a full day during those sessions. The drug sessions are spaced three to five weeks apart, with regular therapy scheduled between the sessions. It's spread over the course of 12 weeks.
“After one MDMA session, we've had a number of people say they could sleep through the night, and before that they could not,” Annie said.
In the initial phases of the clinical trial, about 65 out of 107 patients (61 percent) no longer registered on the PTSD scale. At the one-year follow-up, that number increased to 73 (68 percent.)
Using a Schedule I substance for treatment is not without stigma or concern. Skeptics claim it's an excuse to legalize MDMA. Doctors said participants need to be monitored closely so the drug doesn't affect their blood pressure. There also could be psychological risks if participants are not supported properly by trained therapists.
“Neither the FDA nor any of us think it should be a take-home medicine, where you can pick it up at the pharmacy,” Mithoefer said. “We think it will only be licensed in licensed clinics that are set up to give it to people only under direct supervision.”