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MDMA-assisted therapy reduces PTSD symptoms dramatically

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MDMA-assisted therapy reduces PTSD symptoms dramatically

In a recent study published within the journal Nature Medicine, a bunch of researchers assessed the efficacy, safety, and tolerability of three,4-methylenedioxymethamphetamine-assisted therapy (MDMA-AT) compared to placebo with therapy in treating participants with moderate to severe post-traumatic stress disorder (PTSD).

Study: MDMA-assisted therapy for moderate to severe PTSD: a randomized, placebo-controlled phase 3 trial. Image Credit: eldar nurkovic / Shutterstock

Background 

Roughly 5% of the USA (U.S.) population is affected by PTSD annually. The challenges in treating it arise from aspects just like the dissociative subtype and recurrent trauma. Traditional trauma-focused therapies, coupled with Food and Drug Administration (FDA)-approved serotonin reuptake inhibitors (SSRIs) reminiscent of sertraline and paroxetine, often have high dropout rates and limited efficacy. MDMA-AT, which influences fear memory and encourages prosocial behavior, recently emerged as a promising treatment option.

Given the widespread nature and intricacies of PTSD, together with existing treatment limitations, there’s an urgent need for brand spanking new therapeutic approaches. Although MDMA-AT offers potential, there’s a necessity for further research to evaluate its effectiveness across diverse groups which have traditionally been underrepresented in clinical studies, ensuring its broad relevance.

In regards to the study 

Conducted across thirteen sites, eleven within the U.S. and two in Israel, the current study adhered to international ethical and clinical guidelines while an independent committee supervised to make sure participant safety and adequate sample size.

Adult participants aged 18 and above with a Clinician-Administered PTSD Scale (CAPS-5) severity rating of 28 or higher, indicating a moderate or more severe PTSD condition, were required to stop all psychiatric medications before beginning to avoid potential interactions. These individuals were then randomized equally, either receiving MDMA-AT or a placebo, with assignments kept secret. Independent assessors, blinded to the study’s specifics, gaged PTSD severity using the CAPS-5 assessment. Each participant was assessed by a distinct assessor every time to avoid bias, and assessors underwent thorough training and oversight to make sure consistency.

The trial involved three preparation sessions, after which participants received either MDMA-AT or the placebo along side therapy over three months. During three 8-hour dosing sessions, spaced a month apart, participants were administered doses of MDMA or placebo, with the precise amount various between sessions. After each session, participants engaged in three 90-minute integration sessions to assist process their experiences.

Study results

From August 2020 to May 2022, 324 individuals were screened for the current study, resulting in 121 being enrolled; nevertheless, only 104 participants proceeded to randomization after 17 didn’t progress past the initial stages. These participants were either assigned to a therapy involving the drug MDMA-AT or a placebo. Ultimately, 94 participants accomplished the study, representing a various mixture of gender and ethnicity, with a notable 71.2% identified as female at birth. Moreover, 33.7% identified as non-White, and 26.9% as Hispanic or Latino. On average, participants had been living with PTSD for 16.2 years.

After 18 weeks, results showed that MDMA-AT significantly reduced PTSD symptoms in participants. Secondary outcomes highlighted its positive effect on functional impairment, especially concerning family, social, and skilled features. Further exploratory outcomes revealed that 86.5% of those within the MDMA-AT group displayed clinically significant improvement, showcasing optimistic results.

By the top of the study, 71.2% of participants within the MDMA-AT group now not matched the standards for PTSD, in comparison with 47.6% within the placebo group. Moreover, other aspects reminiscent of alcohol or substance abuse risk, childhood trauma, and the subtype of PTSD didn’t significantly impact these results. Nevertheless, a history of SSRI use did correlate with improved results from MDMA-AT treatment. Notably, female participants and people with a certain baseline depression rating were more more likely to see improved outcomes, whatever the treatment type.

Within the MDMA-AT group, most participants believed that they had received the drug as a result of the positive emotional and physical effects they experienced, highlighting their perceptions. In contrast, the bulk within the placebo group believed that they had received the placebo as a result of a scarcity of noticeable effects.

Nearly all participants experienced no less than one side effect in the course of the study, with most being mild or moderate in nature; just a few participants had cardiac-related unwanted effects, likely stemming from MDMA’s effects on heart rate and blood pressure. There have been also psychiatric unwanted effects, including suicidal thoughts, anxiety, and insomnia. Nevertheless, nearly all of these were also mild to moderate. A small percentage of participants from each groups reported severe suicidal ideation sooner or later, though this was not necessarily linked on to the treatment.

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