Theory and Ethics of MDMA studies

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Feb 20, 2024

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Theory and Ethics of MDMA studies Jazmine Starcher Capella University PSYC-FPX4310 Kerry Grohman January, 2024

Theory and Ethics of MDMA studies Introduction MDMA ( 3,4-Methyl enedioxy methamphetamine ), commonly known as ecstasy or molly (in the crystal form) is known as the drug that increases energy and pleasure. As we know, ecstasy is a street drug used at raves and parties but many scientists are saying it can be used in a therapeutic dose to help with PTSD and social anxiety. There have many multiple studies completed on this topic but that does not mean they are ethical or even have scientific evidence to report their findings. In this paper we are going to decipher if certain studies involving MDMA has been completed ethically as well as finding the theory of the article. Peer reviewed article 1 “ Study protocol for “MDMA-assisted therapy as a treatment for major depressive disorder: A proof of principle study” (Kvam, T. et al 2022 ). M aj or depressive disorder (MDD) is one of the top disability diagnoses and not all treatments have been known to work for every patient. MDMA was given to 12 participants who have all been clinically diagnosed with MDD. MDMA-assisted therapy is when MDMA is given along with psychotherapy. Each participant in this study is at least 18 years old, has at least mild depression that is clinically diagnosed has signed informed consent, has completed an eligibility assessment and had a preparation period to prepare for the study. this study was two months long for dosing of MDMA, followed by integrative sessions to monitor emotions and memory cognition. Safety measures include measuring suicidal behavior. This study was completed ethically as they were of age, of sound mind and had a signed consent form. Peer reviewed article 2

“ 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy for victims of sexual abuse with severe post-traumatic stress disorder: an open label pilot study in Brazil” (Jardim et al, 2021), In Brazil they surveyed 24 participants, due to issues, they were only allowed to survey 3 people, all of whom are victims of sexual abuse; one in adulthood, the other two in childhood. To meet some of the criteria’s, all participants who have been diagnosed with PTSD of at least 6 months, at lest 18 years old and someone who has a failed treatment either psychotherapy or pharmacology. Anyone who has been diagnosed with bipolar 1, personality disorder, drug abuse and or pregnant, they were excluded from the study. These participants were stripped of all current medications and were given MDMA. Results showed changes in emotions, cognition, blood pressure and heart rates. All 3 participants showed a decrease on the PTSD checklist some small changes and others drastic. There were some adverse events but they were short lived, also there were no serious side effects. This study was ethically done; they made sure the participants were of age, were of sound mind, physically capable of handling the side effects and were not pregnant or trying to get pregnant. In this article, the theory that best fits is the Physiological motivation. Our bodies are in need of homeostasis (the body’s ideal resting place). When someone has PTSD they are in constant search on how to regain homeostasis. This study indicates taking MDMA in a therapeutic dosage can result in bring your you back to homeostasis after PTSD, regardless how long ago the event took place. Peer revied article 3 “Concomitant drugs associated with increased mortality for MDMA users reported in a drug safety surveillance database” (Cohen et al, 2021 ), In this article, they research the number of

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deaths that have occurred in the UK and Australia due to MDMA and coadministration of other drugs. According to the crime data in the UK, between years 2001-2007, 1.75 per 100,000 people died while using MDMA alone, with a coadministration of other drugs; 10.89 per 100,000 users passed away. In Australia, 0.05-0.25 per 100,000 people passed away from MDMA only. The toxicology reports indicating alcohol, opioids, cannabis and benzodiazepines were all coadministered. This study was conducted off of data collected by FAERS FDA Adverse Event Reporting Systems database. Of those who have passed way according to this data, 70% were men and the average age was 28. The data also shows people were taking MDMA while also ingesting other substances. Those who ingested cocaine, lithium, nicotine, antimicrobials, HIV medication and psychedelics all had a decreased risk of death. This study was concluded ethical an the data was collected from a reliable source from those who has passed away. The theory for this article would be addiction. All of these people listed in the study died because they were an addict of some form of substance. The reward aspect of addiction makes the addict want to continue that behavior because they gain a reward and pleasure out of using drugs. Peer reviewed article 4 “ MDMA effects consistent across laboratories ” (Kirkpatrick et al, 2014), In this article they study 220 healthy volunteers who have used MDMA in the past. They wanted to see the effects on someone who has been exposed to this drug before. All 220 participants were studies in a clinical setting and were given 125mg of placebo or MDMA. Results showed that some participants had elevated blood pressure and were anxious while others had lower blood pressure and were more in touch with their emotions. They also found that more the participants had been exposed to MDMA, the less side effects they had experienced. These studies were conducted ethically as the participants went through evaluations both mentally and physically and signed

informed consents. The theory for this article is a focus of the connection between the emotions and your health. The amygdala is a structure in the brain that associated with fear, anxiety and aggression. It also regulates stimulants of any sort that inter the blood body to indicate if these are safe or not. This leads to regulation of blood pressure, emotional status (anxiety) and physical movements. Peer reviewed article 5 “ MDMA enhances emotional empathy and prosocial behavior” (Hysek et al 2014), this article studies the difference between men and women on MDMA. 16 men and 16 women were given MDMA in a clinical setting, each were given 125mg of MDMA. Men showed to have an increase in social behavior. Men and women were affected differently when it came to emotion recognition, women performed worse than men when it came to being able to recognized anger or fear. Men also showed more empathy than women. MDMA releases hormones; oxytocin, serotonin and norepinephrine. Oxytocin is known to increase sexual arousal and social bonding. This theory evaluates the difference in hormones and how the effect the brain and physical activity. This study was conducted ethically as it was done in accordance with the local Ethical Committee. Conclusion Now that we have even more of an understanding about the correlation of MDMA and it’s effects on our brains, we can say without a doubt there is more than enough evidence to say that within a standard clinical dosage, MDMA has profound benefits on humans. When MDMA is mixed with other substances many problems possibly even death can occur. The death rate of MDMA as a standalone substance is so minute it is almost non existent.

References: Cohen, I. V., Makunts, T., Abagyan, R., & Thomas, K. (2021). Concomitant drugs associated with increased mortality for MDMA users reported in a drug safety surveillance database. Scientific Reports, 11 (1), 5997-9. https://doi.org/10.1038/s41598-021-85389-x Hysek, C. M., Schmid, Y., Simmler, L. D., Domes, G., Heinrichs, M., Eisenegger, C., Preller, K. H., Quednow, B. B., & Liechti, M. E. (2014). MDMA enhances emotional empathy and prosocial

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behavior. Social Cognitive and Affective Neuroscience, 9 (11), 1645- 1652. https://doi.org/10.1093/scan/nst161 Jardim, A. V., Jardim, D. V., Chaves, B. R., Steglich, M., Ot'alora G, M., Mithoefer, M. C., da Silveira, D. X., Tófoli, L. F., Ribeiro, S., Matthews, R., Doblin, R., & Schenberg, E. E. (2021). 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy for victims of sexual abuse with severe post-traumatic stress disorder: an open label pilot study in Brazil. Revista brasileira de psiquiatria (Sao Paulo, Brazil : 1999) , 43 (2), 181– 185. https://doi.org/10.1590/1516-4446-2020-0980 Kirkpatrick, M. G., Baggott, M. J., Mendelson, J. E., Galloway, G. P., Liechti, M. E., Hysek, C., & de Wit, H. (2014). MDMA effects consistent across laboratories. Psychopharmacology, 231 (19), 3899- 905. https://doi.org/10.1007/s00213- 014-3528-z Kvam, T., Goksøyr, I. W., Stewart, L. H., Repantis, D., Røssberg, J. I., & Andreassen, O. A. (2022). Study protocol for “MDMA-assisted therapy as a treatment for major depressive disorder: proof of principle study”. Frontiers in Psychiatry, 13 , 954388 954388. https://doi.org/10.3389/fpsyt.2022.954388

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