Table of Contents
Introduction
Methylenedioxymethamphetimine (MDMA), commonly known as ecstasy is a psychoactive drug primarily used nowadays as a recreational drug. MDMA was originally synthesized in 1912 by Merck as an intermediate drug designed to stop bleeding. In the first clinical study of the psychoactive properties of MDMA in humans, David Nichols and Alexander Shulgin found that the drug produced “an easily controlled altered state of consciousness with emotional and sensual overtones” (Shulgin and Nichols 1978). Leo Zeff was the first noted psychologist to use MDMA as subordinate to psychotherapy and found impressive results. By the 1980s, there were at least 150 therapists were using MDMA in their practice and an estimated 500,000 therapy and personal growth sessions had been conducted using MDMA as a therapeutic catalyst (Stolaroff 1997; Rosenburn and Doblin 1991).
Unfortunately, during the peak of using MDMA in therapeutic and clinical settings, the drug was also being recreationally under the name “ecstasy.” In 1985, the Drug Enforcement Administration decided to emergency schedule MDMA and categorized it as a Schedule I drug (Amoroso 2015). This caused all clinical research to be terminated. Although the research was limited, MDMA showed potential benefits to treat Post-traumatic stress disorder; it shows promising effects in allowing patients in opening up about traumatic events. Posttraumatic stress disorder (PTSD) may develop after exposure to a traumatic event or repeated stressful experiences that can often cause long-lasting debilitating symptoms that can significantly impact persons daily functioning.
MDMA- assisted Psychotherapy in PTSD Patients
Military personnel and first responders (firefighters, police officers, etc.) are more susceptible to post-traumatic stress disorder. Mithoefer etc. (2018), studied the efficacy and safety of MDMA-assisted psychotherapy for treating PTSD in service members. This study was a randomized, double-blind, dose-response, phase 2 trial at an outpatient psychiatric clinic in the United States. Mitchoefer etc. included only service personnel who were 18 years or older, with a duration of six months or more of chronic PTSD, and who has a Clinician-Administered PTSD Scale (CAPS) total score of 50 or higher. CAPS is a semi-structured interview done that identifies and assesses PTSD through diagnostic and symptom severity scores. Criteria to participate required failure to respond to or inability to tolerate previous pharmacotherapy or psychotherapy and were required to abstain from using psychotropic medication during participation except for sedative-hypnotics or anxiolytics used as needed between MDMA sessions.
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Participants were randomly assigned to three different dose groups of MDMA plus psychotherapy (Mithoefer etc., 2018). The first MDMA session involved three 90-minute psychotherapy sessions in helping prepare participants for the MDMA experience. MDMA was administered to participants before enduring an eight-hour psychotherapy session during 8-hour experimental sessions. It is interesting to note that there were two therapists: a male psychiatrist and a female co-therapist. This allows the patient depending on the trauma they have endured to better relate to one sex better than other. The course of treatment included 18 hours of non-drug psychotherapy and 16-24 hour of MDMA-assisted psychotherapy.
PTSD symptoms in participants significantly were reduced at the 12-month follow up compared to the baseline of all MDMA groups combined. The limitations of this study included the design and the small sample size. The population was mostly made up of white men which is not a great representation of the population that is diagnosed with PTSD. Each follow up conducted of screening participants using CAPS. Screening participants each time using the same instrumentation allows for the study to have test-retest reliability. Although there were limitations, the evidence found that MDMA-assisted psychotherapy can be used under directed supervision as a safe and effective method for treating patients with chronic PTSD.
Clinical Plan for MDMA
Given the stereotypes behind psychoactive drugs would most likely not inspire any investments into the development of a prescription medication of MDMA. Although MDMA has a bad reputation, it has a psychological safety profile that is superior to all other psychedelics (Doblin 2002). MDMA is short-acting with a lifespan of about 4 hours and rarely interferes with cognitive functioning. MDMA in therapeutic settings is useful as it solely operated on emotions. MDMA in the treatment of PTSD is possibly the best combination of psychedelic and clinical indication.
The Multidisciplinary Association for Psychedelic Studies (MAPS) sponsored pilot MDMA dose-escalation studies with PTSD patients, one in Madrid, Spain, conducted under Dr. Pedro Sopelana and Jose Carlos Bouso, a study under Dr. Michael Mithoefer, and working towards sponsoring a study on Israel under the direction of Dr. Moshe Kotler (Doblin 2002). With the sponsorships of these pilot studies, MAPS is outlining a clinical plan for the use of MDMA for PTSD patients. The goals of the study being conducted by Sopelano and Bouso, are (1) to evaluate whether a single dose of MDMA can be administered safely to 29 female survivors of sexual assault with chronic PTSD, (2) to gather preliminary evidence about therapeutic efficacy and (3) to determine which dose or doses should be used in larger scale studies.
The study involves just one treatment session per subject. Involving just one treatment session per subject does not allow to test the effects MDMA entirely has on a person’s form of PTSD as not one person is the same. Phase II Full-Dose Pilot Study in the United States with both sex PTSD patients is under the direction of Dr. Mithoefer. Mithoefer has worked with MAPS to design and obtain approval from the FDA to conduct studies in the United States. The protocol was approved by the FDA in 2001, and of summer of 2002, the study began. These are just a few of the five sponsored pilot studies. The total cost of the studies enumerated above $4,720,000 (Dublin 2002). One downside of the clinical plan is that it is highly expensive to run, but the outcomes could potentially be beneficial.
Comparing MDMA-assisted psychotherapy to prolonged exposure therapy
Currently, there are only two pharmaceuticals that are approved for treating PTSD and many psychotherapeutic options that are available but have high rates of patient dropout rates for a variety of reasons. A key symptom of PTSD is avoidance, so it is no surprise that re-emerging thoughts brought up in therapy can overwhelm the patient and cause them to dropout (Amoroso and Workman 2016). Prolonged exposure (PE) therapy is the most widely used treatment for PTSD and was designed for treating it. This type of therapy requires the patient to relive traumatic experiences as referred to “flooding.”
Only a small percentage of veteran patients are treated with PE because it is emotionally demanding and often aggravates the patient. A typical treatment course for MDMA-assisted psychotherapy requires one to three drug sessions lasting up to eight hours with several follow up non-drug sessions. As for PE, therapy sessions typically last for an hour and ranges from 6 to 19 sessions. Amoroso and Workman conducted a meta-analysis that suggests that MDMA-assisted psychotherapy has comparable outcomes to PE. Patients who partake in PE are put into a heightened state of arousal with little time to process the experience before leaving their session fully. MDMA-assisted psychotherapy allows the patient to explore different aspects of their trauma that PE cannot offer.
References
- Feduccia, A. A., & Mithoefer, M. C. (2018). MDMA-assisted psychotherapy for PTSD: Are memory reconsolidation and fear extinction underlying mechanisms? Progress in Neuro-Psychopharmacology & Biological Psychiatry, 84, 221-228. doi:http://dx.doi.org/10.1016/j.pnpbp.2018.03.003
- Mithoefer, M. C., Mithoefer, A. T., Feduccia, A. A., Jerome, L., Wagner, M., Wymer, J., . . . Doblin, R. (2018). 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy for post-traumatic stress disorder in military veterans, firefighters, and police officers: A randomized, double-blind, dose-response, phase 2 clinical trial. The Lancet Psychiatry, 5(6), 486-497. doi:http://dx.doi.org/10.1016/S2215-0366(18)30135-4
- Amoroso, T. (2015). The psychopharmacology of ±3,4 methylenedioxymethamphetamine and its role in the treatment of posttraumatic stress disorder. Journal of Psychoactive Drugs, 47(5), 337-344. doi:http://dx.doi.org/10.1080/02791072.2015.1094156
- Amoroso, T., & Workman, M. (2016). Treating posttraumatic stress disorder with MDMA-assisted psychotherapy: A preliminary meta-analysis and comparison to prolonged exposure therapy. Journal of Psychopharmacology, 30(7), 595-600. doi:http://dx.doi.org/10.1177/0269881116642542
- Oehen, P., Traber, R., Widmer, V., & Schnyder, U. (2013). A randomized, controlled pilot study of MDMA (±3,4-methylenedioxymethamphetamine)-assisted psychotherapy for treatment of resistant, chronic post-traumatic stress disorder (PTSD). Journal of Psychopharmacology, 27(1), 40-52. doi:http://dx.doi.org/10.1177/0269881112464827
- Cohen, D. B. (2016). Countering the dynamics of dominance: How therapists create safety through egalitarianism in MDMA-assisted psychotherapy for women veterans with complex posttraumatic stress disorder (Order No. AAI3726294). Available from PsycINFO. (1830075818; 2016-37853-052).
- Hutchison, C. A., & Bressi, S. K. (2018). Mdma-assisted psychotherapy for posttraumatic stress disorder: Implications for social work practice and research. Clinical Social Work Journal, doi:http://dx.doi.org/10.1007/s10615-018-0676-3
- Doblin, R. (2002). A clinical plan for MDMA (ecstasy) in the treatment of posttraumatic stress disorder (PTSD): Partnering with the FDA. Journal of Psychoactive Drugs, 34(2), 185-194. doi:http://dx.doi.org/10.1080/02791072.2002.10399952
