The total amount of fluid intake and intravenous saline application was also only recorded in patients performing fluid restriction. With side effects specified as the outcome of interest, the risk of bias assessment found that of eight studies included in the meta-analysis, seven were rated as having a high risk of bias 3, 4, 36, 38, 40,41,42, and one was rated as having some concerns 6 (see Fig. 3 and Fig. S2). The Cohen’s Kappa statistic for overall bias was 1.00 (i.e., excellent agreement between reviewers). MAPS-sponsored clinical trials are conducted by the MAPS Public Benefit Corporation (MPBC), a wholly owned subsidiary of MAPS formed in 2015 for the special purpose of balancing social benefits with income from legal sales of MDMA, other psychedelics, and marijuana. Although not a classic psychedelic (such as psilocybin and LSD), MDMA is a synthetic amphetamine compound which as far back as the 1970s, was used by mental health professionals in conjunction with talking therapy to enhance patients’ access, processing, and communication of difficult emotions and experiences. In a 2002 paper published in Science, Ricaurte and co-workers described experiments performed in nonhuman primates demonstrating severe dopaminergic (and to a lesser extent serotonergic) neurotoxicity of MDMA.263 These authors suggested that MDMA might put users at risk for developing Parkinson’s disease.

Trial registration

Participants agreed to be recontacted for potential enrollment in a long-term follow-up study, which will include follow-up measures to assess the durability of the treatment. Insufficient research also exists in regards to MDMA interactions with pharmaceuticals and drugs of abuse. Psychosis could be introduced by MDMA in those with psychotic disorders or mania (with or without psychosis) in those with Bipolar I Disorder. Insufficient research exists in these populations to describe the outcomes of MDMA ingestion, so caution is warranted. Participants with a history of coronary artery occlusion and cardiovascular conditions, including torsade de pointes, heart failure, hypokalemia, prolongation of QT/QTc interval, or family history of Long QT Syndrome may be at greater risk for negative effects after ingesting MDMA if they have a history.

Risk of bias

Here’s our MDMA-assisted therapy guide for everything you need to know about this novel treatment approach. When combined with therapy, MDMA is proving helpful for PTSD and other mental health conditions. Learn more about the effects, dosage, therapeutic approach, and clinical trial findings below. Experts are tapping into MDMA’s effects as part of therapy for severe posttraumatic stress disorder (PTSD), a mental health condition that affects nearly 3.5% of U.S. adults.

• Psilocybin also increases emotional empathy (51), mindfulness-related capacities (52,53) acceptance, and connectedness while reducing avoidance (54), which may all facilitate PTSD treatment.
• Although the number of participants who reported suicidal ideation varied throughout the visits, prevalence never exceeded baseline and was not exacerbated in the MDMA group.
• The FDA is reviewing the evidence for MDMA-AT for the treatment of PTSD, which may involve future rescheduling and approval of MDMA for this purpose (15).
• In addition, treatment options such as community-based care and group therapy, and robust coverage by health insurance will be needed, he added.
• This finding is not limited to MDMA-AP research (e.g., see 29, 51) and is consistent with concerns about safety reporting in trials of mental health interventions more broadly 52.
• Dr. Herzberg offers individual and couple therapy, ketamine-assisted therapy, and psychedelic integration with a specialization in developmental trauma.

A thematic analysis of MDMA-related harm and harm reduction experiences and knowledge in Aotearoa New Zealand

• While both P-AT and MDMA-AT findings are promising, there are several challenges with psychedelic research that should be considered when interpreting the evidence.
• While the new study focused on the use of MDMA-assisted therapy for PTSD, Strassman said the results may support research on other psychedelics.
• For all studies, withdrawal for any reason was rated as having moderate certainty of evidence.
• At least two psychotherapists will be there for the whole session to help you through what can be a physically and emotionally draining process.

The researchers also used the Sheehan Disability Scale (SDS) to examine functional impairment. In this case, this assessment looked at how much PTSD impaired participants’ day-to-day lives. The current study included a diverse sample and was a double-blind, placebo-controlled phase 3 trial.

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. The results of the new study were similar to an earlier phase 3 clinical trial by the same group, in which 90 people received MDMA-assisted therapy or an inactive placebo with therapy. People from racial and ethnic minorities and other diverse groups are underrepresented in clinical trial research, even though some of these groups face a higher risk of certain health conditions.

• These included the PTSD Checklist for DSM-5 (PCL-5), the MINI for DSM-5, the Structured Clinical Interview for DSM-5 Screening Personality Questionnaire and Structured Clinical Interview for DSM-5 Personality Disorders (SCID-5-SPQ and -PD), the Lifetime C-SSRS, medical history, and pre-study medications.
• Further, we could only draw conclusions regarding acute and short-term side effects because insufficient data were available regarding longer-term risks beyond active treatment.
• While other psychedelic compounds such as LSD, psilocybin, and ibogaine have been more extensively studied than MDMA with respect to their abilities to treat SUDs, the minimal perceptual disturbances caused by MDMA may offer a distinct advantage over the classical hallucinogens.
• No funding for these trials is yet available from governments, for-profit pharmaceutical companies, or major foundations.
• A comprehensive understanding of potential safety issues in MDMA-AP is needed to inform both ongoing research and translation to clinical practice.

Each experimental session was followed by three 90-min integration sessions that were spaced ~1 week apart to allow the participant to understand and incorporate their experience. The first integration session always occurred on the morning after the experimental session, and the remaining two integration sessions occurred over the following 3–4 weeks (Fig. 1). Blood pressure, body temperature and heart rate were measured at the end of each experimental session prior to discharging the participant. Given molly mdma that PTSD is a strong predictor of disability in both veteran and community populations33, it is promising to note that the robust reduction in PTSD and depressive symptoms identified here is complemented by a significant improvement in SDS score (for example, work and/or school, social and family functioning). Approximately 4.7 million US veterans report a service-related disability34, costing the US government approximately $73 billion per year35. Identification of a PTSD treatment that could improve social and family functioning and ameliorate impairment across a broad range of environmental contexts could provide major medical cost savings, in addition to improving the quality of life for veterans and others affected by this disorder.