A Critique on the Efficacy of 3,4-methylenedioxymethamphetamine Assisted Psychotherapy in Subjects with Refractory ConditionsMichael S. LayeuxNorth Idaho CollegeIntroductionIn this paper I hope to give a clear and concise critique of the article: “The safety and efficacy of 3,4-methylenedioxymethamphetamine assisted psychotherapy in subjects with chronic, treatment-resistant posttraumatic stress disorder: the first randomized controlled pilot study” published in the Journal of Psychopharmacology in 2010 by Michael C Mithoefer, Mark T Wagner, Ann T Mithoefer, Lisa Jerome and Rick Doblin. In this article, the authors collected data from observational analysis of a test group of patients who had chronic posttraumatic stress disorder that was refractory to all currently available psychotherapy and psychopharmacology.
The sample group was split between being given 3,4-methylenedioxymethamphetamine (MDMA) and a placebo. They put forth their findings that there was a significant decrease in Clinician-Administered PTSD Scale (CAPS) scores in those whom were given MDMA coupled with drug and non-drug psychotherapy, compared to those in the placebo group whom were given a placebo and psychotherapy. AbstractIn the abstract of this article, the authors put forth that case studies of psychiatrists administering MDMA coupled with psychotherapy before MDMA’s criminalization in 1985 were very promising. This is the first completed clinical trial using MDMA as a therapeutic adjunct since it’s criminalization.
They collected their sample, and randomly assigned the 20 patients to psychotherapy with concomitant active drug (n=12) or inactive placebo (n=8) during 8-hour experimental therapy sessions. Both groups were given preparatory and follow up non-drug psychotherapy. The primary outcome measure was the change in CAPS scores at two different points, 4 days and 2 months, after the experimental therapy sessions. They also summarized some of their findings in significant decreases in baseline CAPS scores in the MDMA therapy group, in comparison to the placebo group. They also found through the safety tests that were administered for Neurocognitive function, blood pressure, and drug-related serious adverse effects that MDMA can be administered to PTSD patients without harm and may have potential use in patients refractory to other treatments. This abstract helps outline the outcomes, and potential future outcomes for MDMA assisted psychotherapy in patients. The reader should have a clear understanding that this research is fundamental to finding novel ways of dealing with treatment-resistant conditions. IntroductionIn the introduction to this paper, the authors delve into the definition of some of the clinical terms interrelated to the research and some statistics and references for the amount of PTSD prevalent in all societies.
The authors go on to point out that the current treatments of psychotherapy and psychopharmacology do not have the efficacy necessary to help the population which suffers with PTSD. They note existing research and various articles dictating the need for a more effective means of treatment for PTSD that can help the 25-50% of patients with PTSD who are resistant to current treatments. They delve briefly into the history of MDMA use in therapy by psychiatrists in the United States and Europe prior to its criminalization and talk about its general effects. In the introduction they indicate the benefits of the fear-reducing tendencies of MDMA for patients with PTSD who are revisiting their trauma with a deep level of emotional engagement. This section of the paper outlines the history of MDMA’s therapeutic use and projects potential pathways for the future of this chemical coupled with Cognitive Behavioral Therapy.
The researchers collected their sample size for this experimental observational study by recruitment through letters to psychotherapists and internet advertisements. Those whom were recruited were then put through a scripted telephone screening identifying previously diagnosed medical or psychiatric exclusion criteria. After the phone screening and after receiving informed consent the potential candidates were screened in various outpatient clinics by a physician and an independent rater. 20 in total met all enrollment criteria and were inducted into the trial. The researchers based their data on the current state of their physical and psychological well-being, specifically basing their change in PTSD intensity using the DSMR-IV-R criteria for the diagnosis of PTSD and a CAPS score of greater than or equal to 50 (moderate-severe symptoms). The patients must have also met all other criteria put forth by the researchers to prevent confounding variables.
The control in this experiment was the placebo group. The independent variable was determined by whether a patient’s CAPS score decreased or increased after the experiment. The response variable was the people whom were given the active dose of MDMA coupled with the experimental therapy session. The ratio of the sample was 60% MDMA (n=12) to 40% placebo (n=8) coupled with psychotherapy. All patients, all investigators, and the independent rater blinded. There were two experimental sessions given to each patient, with a preliminary meeting with a male-female therapist team to discuss the format for the experimental sessions. There was an integration session with the therapist team the morning after each experimental session, and phone contact every day for one week following each experimental session. The blind was broken 2 months after the second experimental therapy session, and the data shared with the participants of the clinical trial.
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