Recent research into the use of MDMA-assisted psychotherapy for treating post-traumatic stress disorder (PTSD) suggests that soon clinicians will have a new, profoundly effective tool in their arsenal. PTSD develops as a result of acute or chronic trauma and can have devastating consequences. Characterized by hypervigilance, anxiety, withdrawal and isolation, destructive behavior, and intrusive thoughts, PTSD is commonly treated with a combination of psychotherapy and medications called selective serotonin reuptake inhibitors (SSRIs), such as Prozac, Zoloft, and Paxil.
By utilizing MDMA in conjunction with psychotherapy, studies suggest that clinicians can make huge therapeutic strides with PTSD patients. Now in Phase 3 clinical trials, MDMA-assisted psychotherapy is expected to be approved for widespread use by the FDA as early as 2022.
A recent study, however, points at evidence that patients who use SSRIs for treatment and management of their PTSD might be at a disadvantage when it comes to MDMA-assisted psychotherapy.
It has been long understood that attempting MDMA-assisted psychotherapy while using SSRIs for management of PTSD inhibits the effectiveness of the MDMA treatment. But recently a team of researchers, reviewing the results of six phase 2 clinical trials, discovered that those who tapered off SSRIs prior to undergoing MDMA-assisted psychotherapy also experienced suboptimal results.
Patients tapered off their SSRIs as part of study eligibility. They had to be completely off SSRIs for five half-lives of the medication before beginning the MDMA trials to ensure the medications were completely out of their systems. After reviewing the data, researchers found that those who tapered had significantly less dynamic results than those who had never taken SSRIs as part of their treatment protocol.
“This new publication shows that recent prior use of SSRIs, even if the person is no longer taking them, can reduce the treatment response to MDMA,” said study author Allison Feduccia, PhD. “While the evidence is preliminary and from a relatively small number of participants, the findings suggest PTSD patients will have much better chance of getting better if they discontinue SSRIs weeks prior to MDMA-assisted psychotherapy. We don’t have enough data yet to know what the recommended time is to be abstinent from SSRIs.”
Weaning off SSRIs can result in a slew of side effects and care should be taken to approach discontinuation slowly. “Mild to severe withdrawal effects can occur as the brain adjusts to no longer having the medication on board,” said Dr. Feduccia. “Some people experience severe enough symptoms to have what’s called a discontinuation syndrome which can last for weeks to months.”
For patients as well as clinicians, the findings mean a more focused approach to discontinuation of SSRIs should be utilized prior to beginning MDMA-assisted psychotherapy. For those interested in participating in an MDMA-assisted psychotherapy clinical trial, Dr. Feduccia recommends not tapering SSRIs until they are screened and enrolled in the studies. And any tapering should be done after consultation with a clinician so patients can be monitored for side effects or symptoms of discontinuation syndrome.