The drug 3,4-methylenedioxymethamphetamine, better known as MDMA or ecstasy, has been a target in the war against drugs for many years. The U.S. Drug Enforcement Administration made it illegal in 1985. Since then, researchers have studied the potential therapeutic benefits of legal MDMA. In August 2017, the Food and Drug Administration gave ecstasy the breakthrough therapy designation for treating PTSD.
What Is the Breakthrough Therapy Designation?
The FDA gives treatments a breakthrough therapy designation[1] when they meet two requirements. First, their purpose must be to treat life-threatening or serious conditions or diseases either alone or in combination with other drugs. Second, preliminary clinical evidence must show that they can greatly improve existing therapies in at least one treatment area.
The agency has used this designation since 2012 to speed up the development and review process for treatments. About 200 drugs have been labeled breakthrough therapies already.
Current Methods for Treating PTSD
Rehab centers can provide treatment for people who suffer from PTSD. Cognitive behavioral therapy is the most common form of treatment that they use because it’s the most effective. However, other methods can be effective too.
For PTSD, CBT focuses on the trauma and changing behaviors and thought patterns. Individuals engage in treatment during and outside of weekly sessions to learn skills and apply them to their symptoms. The treatment period is usually 12 to 16 weeks.
Eye movement desensitization and reprocessing is a type of CBT that helps people process trauma-related emotions, memories and thoughts. This treatment method involves recalling the trauma while the therapist uses a motion or sound. It takes eight steps, some of which are repeated until negative feelings about the memory are dampened and positive feelings are strengthened.
How MDMA Could Help Peoplw with PTSD
Posttraumatic stress disorder is a serious, life-threatening condition when people don’t receive treatment for it. About 7 percent of the American population develops PTSD at some point in their lives.
As a stress-related disorder, PTSD causes reduced psychosocial and cognitive function. Those who suffer could relive traumatic events through flashbacks and nightmares. They often have trouble sleeping and feel detached from normal life. Many people also can’t keep their jobs, struggle in relationships and abuse substances that mask their symptoms. PTSD is a factor in 27 percent of suicides as well.
Research indicates that combining legal MDMA with therapy can significantly reduce PTSD symptoms. By dampening the emotional response to memories, the drug allows people to recall traumatic experiences so that they can work through them.
Promising Results From Phase II Studies
The Multidisciplinary Association for Psychedelic Studies, a nonprofit group, funded a small study that was published in 2011. The results suggested that ecstasy may help treat PTSD. Larger, Phase II clinical trials also funded by the group have good results as well, says MAPS Executive Director Rick Doblin.
The research involved 107 people who had chronic, treatment-resistant PTSD for 17.8 years on average. Those who weren’t in the control groups received a dose of MDMA and participated in therapy sessions. Each occurrence was spaced three to five weeks apart and held in a clinic. The participants also received integration and preparatory sessions.
Two months after the treatment, 61 percent of the individuals didn’t have PTSD anymore. At the follow-up one year later, 68 percent had overcome the disorder. These results demonstrate that MDMA-assisted psychotherapy can reduce defensiveness and fear while enhancing communication, compassion, empathy and introspection. These neurological effects improve the therapeutic process.
In addition, the MAPS study found that serious adverse effects from MDMA were non-life-threatening and uncommon. It recorded increased blood pressure, body temperature and heart rate in a dose-dependent manner that wasn’t an issue for healthy people. These effects quickly wore off.
Approval for Phase III Clinical Trials
Alongside the breakthrough therapy designation, the FDA gave MAPS approval in July 2017 to fund two Phase III studies. The studies will assess the safety and efficacy of MDMA-assisted therapy.
MAPS will accept 200 to 300 people who are 18 and older and have PTSD. The trials will be held at sites in the United States, Canada and Israel. The researchers will choose participants at random to receive three, day-long therapy sessions while taking MDMA. The other individuals will receive a placebo with therapy. The trial will last for 12 weeks and include 12, non-drug integration and preparatory sessions for 90 minutes each.
In 2017, the group started an open-label, lead-in training study and plans to begin enrollment for the first trial in the summer of 2018[2]. It hopes to complete the study by 2021 and is seeking donations for an estimated cost of $26 million.
Get PTSD Treatment Now
Don’t wait for a scientific breakthrough to get help for PTSD. You deserve to live a normal life without fear, anxiety or depression from past experiences. If you struggle with addiction and PTSD, call us today to learn more about our services.
Sources:
[1] http://www.maps.org/news/media/6786-press-release-fda-grants-breakthrough-therapy-designation-for-mdma-assisted-psychotherapy-for-ptsd,-agrees-on-special-protocol-assessment-for-phase-3-trials
[2] http://www.maps.org/research/mdma/ptsd/phase3/timeline
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