These findings are consistent with results of previous meta-analyses 14, 23, 24 and evidence from healthy subjects 11, 50. No differences between the MDMA-AP and control groups were observed in the odds of experiencing any TEAE, psychiatric TEAE or in withdrawal from the study, suggesting that side effects typically resolved within 7 days of MDMA-AP sessions and did not result in study withdrawal. Contrary to expectations, sub-group analyses found that people with PTSD who received MDMA-AP had 0.5 lower odds of experiencing any TEAE. Notably, only two studies were included in this meta-analysis, both of which used a low-dose MDMA active control rather than inert placebo. While active placebos improve blinding in studies evaluating MDMA-AP, this may complicate comparison of safety data between groups where treatments are not pharmacologically-distinct 1.
Health Challenges
- This is the final stage before potential approval from the FDA, which would make it available as a treatment option in the United States.
- Manualized psychotherapy is inner-directed and designed to invite inquiry and facilitate a therapeutic effect by providing support for approaching difficult material that does not interfere with the participant’s spontaneous experience.
- These transient elevations did not require clinical intervention, including among the subset of participants with well-controlled hypertension.
- Full-text articles were reviewed by two independent authors (JC and AAG), with disagreements resolved by consensus.
- Dr. Quevedo is trained in MDMA-assisted psychotherapy and has worked as a therapist on MDMA phase 2 and phase 3 trials.
Of note, MDMA did not increase the occurrence of suicidality during the study. Street drugs don’t have the same therapeutic effects, and you may not know their exact dose and purity. About 71% of participants who received MDMA did not how long does mdma stay in body meet the criteria for PTSD at the follow-up time.
MAPS PBC Publishes Results of Successful Confirmatory Phase 3 Trial of MDMA-Assisted Therapy for PTSD
Seizures can be more likely to occur while on MDMA in people with a prior history of seizures. Seizure disorders have not been tested with MDMA and therefore it is not recommended for patients with this history to participate in clinical trials. MDMA smooths communication, makes things look less threatening and fearful, nurturing people’s ability to experience each other in a more positive way. As Mithoefer notes, “It makes sense then that MDMA could make it easier to communicate if people weren’t as sensitive to interpreting someone else’s expression as being threatening.”In doing so, MDMA paves a way for and accelerates bonding between therapists and a patient. Required bonding time is reduced and a strong “therapeutic alliance” is formed. In all types of psychotherapy, this alliance is a known contributor to optimal outcomes..
A thematic analysis of MDMA-related harm and harm reduction experiences and knowledge in Aotearoa New Zealand
Lastly, only four studies assessed the dose-dependent nature of side effects. It is critical for future studies to examine at what dose each side effect emerges to identify the ideal dosage and reduce unnecessary risks. Cohen’s kappa was calculated for overall bias to determine agreement between reviewers. Any conflict between reviewers was resolved through discussion to reach consensus. The vast majority of total participants (102 of 104) experienced at least one treatment-emergent adverse event (TEAE), while a total of seven experienced a severe TEAE (five in the MDMA group; two in the placebo group). The most common TEAEs included nausea, decreased appetite, muscle tightness, and excessive sweating.
“Both clinical trials and the SAP have safeguards and requirements in place to protect the health and safety of patients and trial participants, help ensure quality of the drug, and provide administration and oversight by qualified professionals,” said Tammy Jarbeau. This study demonstrated that MDMA-AT was a more cost-effective treatment than placebo with therapy for patients with chronic moderate or higher severity PTSD. Inputs with the highest impact on model findings were quality of life benefits in treatment and comparator arms. In that study, after three 8-hour treatment sessions spaced around 4 weeks apart, 67% of those who received MDMA-assisted therapy no longer qualified for a PTSD diagnosis, compared to 32% of those who received placebo with therapy.
- A health state transition economic model with a cost-effectiveness analysis was developed from the payer perspective.
- Mental health experts say these emotions may create an ideal setting for people with PTSD to open up about difficult emotions, do more self-reflection, and work through the events that may have triggered their condition.
- However, researchers require larger-scale clinical trials to show whether it has the potential to be an effective treatment.
The cost of MDMA-AT treatment was $48,376 ($36,000 for MDMA and $12,376 for all psychotherapy components of MDMA-AT), with a $16,125 price for a single MDMA-AT session ($12,000 for MDMA, $2,357 for 8-hour psychotherapy, and $1,768 for preparation and integration sessions). The base-case analysis included patients with PTSD of moderate or higher disease severity, the economic burden from the payer’s perspective, a 5-year modeling time horizon, and 3.5% annual discount rates on cost and utility inputs. A brief description of all model input parameters and relevant data sources for base-case analysis are presented in Table 1. To explore the cost-effectiveness of midomafetamine-assisted therapy (MDMA-AT) compared to placebo with therapy (PT) in US healthcare settings. Veterans interested in MDMA-AT can explore opportunities to participate in approved clinical trials underway within the VA setting. Studies examining MDMA-assisted therapy for PTSD can be found on ClinicalTrials.gov.
Psilocybin-Assisted Therapy
Like other psychedelics, it can influence how people think and their perception of reality. The authors of this study note that MDMA helps eliminate fear and promote openness. Researchers are continuing to look into how psychedelics can treat medical conditions.
Expert recommendations for Germany’s integration of psychedelic-assisted therapy
The system that patients and health-care providers have to navigate is one challenge. But patients also have to be able to find a doctor to support their application, and a therapist who specializes in psychedelic-assisted therapy, which can be difficult. Melanie Dignam, a therapist in Toronto, said she’s seen success stories with psychedelic-assisted therapy, but has mostly stepped away from it because of the impact the application process can have on patients, who have been failed by conventional treatments and medications. The lawsuit is named after the late Thomas Hartle, a cancer patient who was the first Canadian to participate in a legal psychedelic-assisted therapy session after being approved in 2020, through the criminal code exemption, known as Section 56. When his one-year permission expired, he reapplied, but waited over 500 days and got turned down.
There are 2 essential components of set and setting, both of which influence the individual’s response to the drug and the overall experience during the medicine session. Set consists of the expectations and intentions that the patient comes in with, whereas setting refers to the physical, social, and cultural context in which the drug is taken (76). Protocols also typically require the presence of 2 therapists for all medicine administration sessions, though only one is required to be present during other pre- and post-administration sessions in some cases (59).
Potentially Significant Drug-Drug Interactions with MDMA
- The STAI is a well-established and stable measure of cross-situational (trait) and current mood (state) anxiety35.
- Post-traumatic stress disorder (PTSD) represents a psychiatric syndrome caused by exposure to different types of traumatic events, mostly related to war, sexual abuse, or natural disasters 1.
- To be clear, it is not the drug alone that allows the patient to work through the trauma and enhance their capacity to have crucial insights.
This cost-effectiveness analysis estimated the healthcare costs per QALY in patients with chronic PTSD of moderate or higher severity, comparing MDMA-AT and placebo with therapy. Model inputs were based on data from three clinical trials (two phase III and one long-term follow-up), a real-world economic BOI analysis, and treatment patterns in modern clinical practice to minimize assumptions and provide the most accurate price estimate. This was considered cost-effective as the WTP value in the model was $150,000 per QALY. The threshold was defined by the World Health Organization recommendation stating that the cost-effective boundary should be between one and three times the Gross Domestic Product (GDP) per capita 16. The World Bank data for 2022 reported $76,329.58 GDP per capita for the US 17, yielding a cost-effective threshold range between $76,330 and $228,989 per QALY, which corresponds to the MDMA medication cost of $11,056 to$30,242 per session. However, the authors used a median value (approximately $150,000) to have a fair comparison and considered it relevant for the modern US healthcare system.