MDMA for Treating PTSD – FDA Approves Phase 3 Trials
To be clear, methylenedioxy-methamphetamine, known on the street as MDMA, molly, “E” or ecstasy, is an illicit and extremely dangerous “club” drug. Misuse can cause brain damage and even death.
Because of its euphoric sensory effects, MDMA is popular on the music festival circuit, though rarely does a year go by without news of another tragic and fatal overdose.
Several small clinical studies, however, have successfully harnessed MDMA’s potent properties to treat severe cases of post-traumatic stress disorder, and the Food and Drug Administration in November granted permission for a large-scale Phase 3 clinical trial.
How Were the PTSD MDMA Studies Conducted?
Far from the club and music-festival scene, the drug was administered to patients like C.J. Hardin, a three-tour veteran of the wars in Iraq and Afghanistan. Hardin suffered from suicidal depression, alcoholism and lost his marriage after traditional PTSD treatments failed him.
Individuals in the study underwent 12 weeks of psychotherapy, which included MDMA in three eight-hour sessions.
“The medicine allows them to look at things from a different place, reclassify them,” a psychiatric nurse, Mrs. Mithoefer, told the New York Times. She and her husband, Dr. Michael C. Mithoefer, a psychiatrist, conducted the trials. “Honestly, we don’t have to do much,” she added. “Each person has an innate ability to heal. We just create the right conditions.
The flood of hormones and neurotransmitters MDMA releases in the brain bring on feelings of compassion, trust, love, empathy and wellbeing. As a result, researchers and some patients involved in the trial, suggest they were able to face traumatic issues that normally fueled fear and exacerbated negative symptoms of PTSD.
An earlier study published in 2012 in the Journal of Psychopharmacology found that 56 percent of participants experienced a decrease in their symptoms after three doses of MDMA. Two-thirds of the patients involved no longer met the clinical criteria for PTSD by the end of that trial.
The success of early trials cannot overshadow the dangers of the illicit drug. In most cases, consumers have no idea what the drug might be cut with and take it at a great risk to their own health and wellbeing.
What are the Hazardous Side Effects of MDMA?
Misuse and abuse of MDMA, reports the National Institute on Drug Abuse comes with a host of hazardous side effects, especially in the days after consumption, that can include some of the following:
- Depression, anxiety and sleep problems
- Irritability, aggression and impulsiveness
- Lack of appetite
- Memory and attention problems
- Large doses of MDMA disrupt the body’s ability to regulate its temperature, which can lead to liver, kidney and heart failure resulting in death
Dr. Charles R. Marmar, head of psychiatry at New York University’s Langone School was not involved in the MDMA trials, but keeps a watchful eye on it because PTSD is so difficult to treat.
“I’m cautious but hopeful,” Marmar told the New York Times. “If they can keep getting good results, it will be of great use.” The doctor noted, however, “It’s a feel-good drug and we know people are prone to abuse it. Prolonged use can lead to serious brain damage.”
In the latest MDMA trial, patients included firefighters, victims of sexual assault, police officers and combat veterans, like Hardin, who had not responded to traditional therapy approaches.
Trial participants, on average, suffered symptoms of PTSD for upwards of 15 years. The Phase 3 clinical trial, a final step toward making MDMA a prescription drug, will include 230 patients.
Like opioids, prescription painkillers and heroin, MDMA comes with a high potential for abuse and addiction and there’s no room for experimentation. Administered to the right patients by a knowledgeable physician, though, this “club” drug might help scores of people break free from the painful condition of PTSD.
“It changed my life,” Hardin told the New York Times. “It allowed me to see my trauma without fear or hesitation and finally process things and move forward.”
This infographic outlines some of the issues of treating PTSD with MDMA-assisted psychotherapy.
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