Overview of CPT+MDMA Pilot Study
Cognitive Processing Therapy (CPT; Resick, Monson, & Chard, 2016), a 12-session protocol-based psychotherapy, is one of the treatments with the best evidence for healing Posttraumatic Stress Disorder (PTSD) to date. In the most effective studies, 50-60% of people no longer have PTSD at the end of treatment, indicating that the treatment does not work for everyone. In an effort to improve outcomes for people living with PTSD, we are testing the combination of CPT with MDMA to see if this may be an additional treatment option.
Relationships are fundamental in our worlds – whether they are present or absent, supportive or stressful. When an individual has experienced a trauma and is struggling in its aftermath, not only is the individual impacted, but so are those around them. Treating the aftermath of trauma in the context of relationships therefore has strong potential power. Cognitive Behavioral Conjoint Therapy for Posttraumatic Stress Disorder (CBCT for PTSD) was developed to work with couples in the context of trauma recovery (Monson & Fredman, 2012). CBCT for PTSD has demonstrated decreases in PTSD symptoms, increases in relationship satisfaction and improved partner functioning in numerous trials (e.g., Monson et al., 2012; Schumm et al., 2013). Additionally, MDMA-assisted psychotherapy has demonstrated large decreases in PTSD symptoms across several studies (Mithoefer et al., 2019). Therefore, in an effort to facilitate deep healing in the context of relationships, we combined CBCT for PTSD with MDMA in a pilot trial. This pilot trial, which was run with six couples where one person had PTSD, showed large improvements in PTSD symptoms, larger than those we’ve seen in CBCT alone (Monson et al., under review; Wagner et al., 2019). Additionally, both members of the couple experienced increases in relationship satisfaction. These compelling results have lead us to test this approach with more couples in order to show that it works and creates powerful healing, not only for the person with PTSD, but also for their loved ones. We are aiming to run a trial with 40 couples, one of whom has PTSD, to be able to show the effects of the treatment on a larger scale. If these results are compelling, we would therefore hope to be able to offer this treatment to those who need it.
Combining treatments (MDMA assisted therapy and CPT or CBCT) that are protocol-based allows for a clear template to be used to frame the treatment, and potentially offers a gateway for other therapists who practice these treatments in healthcare settings to then integrate the use of MDMA. Additionally, combining these treatments offers other options for the use of MDMA in the treatment of PTSD beyond a non-directive, supportive model, and allows us to begin to empirically test the active components of treatment in order to most effectively and parsimoniously provide treatment. The pilot study of CBCT for PTSD with MDMA is now complete, with a case study published in the Journal of Psychoactive Drugs (Wagner et al., 2019), and the main outcomes in preparation for submission for publication. The same study investigator team from the CBCT+MDMA pilot study including Dr. Anne Wagner, Dr. Candice Monson, Dr. Michael Mithoefer, and Annie Mithoefer, BSN, will lead the CPT+MDMA study.
Dr. Anne Wagner has been having regular meetings with Rebecca Matthews (Associate Director of Clinical Operations) and Melissa Field (Clinical Research Associate) from MAPS Public Benefit Corporation to work on the study protocol, logistics and planning. Anne previously worked with Rebecca on the CBCT+MDMA pilot, and they have working templates for much of the work they are doing. The new component underway is creating an Investigator-Sponsored study in Canada, and therefore time is being spent figuring out the logistics of drug importation, Health Canada approvals, Section 56 exemptions for the study Psychiatrist, and budgeting.
The study team has been selected, and all new primary and secondary study therapists are attending MAPS MDMA therapist trainings in March (3 secondary study therapists, 2 physicians and Anne; Anne and the physicians are being paid for by MAPS US outside of the study budget) and May (1 primary study therapist) 2019. Anne and the team will be aiming to finish the protocol by the end of May and identify the Licensed Dealer for the drug importation by the end of March. Once MPBC has approved the budget, a research coordinator will be identified to assist with study start-up, including ethics submissions, the Health Canada submission and space set-up for sessions.
As of October 24th, 2019, the protocol has been written and has gone through multiple rounds of revisions. The final version is ready to be submitted to Health Canada for approval. A research coordinator, Stephanie Buono, has been hired, and the final budget is being approved by MAPS/MPBC. After pursuing multiple options, we are awaiting confirmation from the licensed dealer, who is currently serving as the licensed dealer for the Phase III site in Vancouver. The ethics submission is nearing completion, and negotiations have been underway with Ryerson and MAPS regarding finalizing contracts.