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Concomitant medications associated with ischemic, hypertensive, and arrhythmic events in MDMA users in FDA adverse event reporting system.

Frontiers in psychiatry
May 5, 2023
Tigran Makunts et al. (5 authors)
Journal ArticleHuman Study
Study Details

Study Goal

The researchers aimed to investigate cardiovascular adverse events associated with MDMA use, particularly when combined with other substances.

Results Summary

The study found 17 cases of cardiovascular adverse events in individuals who took MDMA alongside other substances, all of which were previously linked to such events. MDMA was not marked as the primary suspect in any of these reports.

Population

Individuals reporting adverse events in the FDA Adverse Event Reporting System, including those using MDMA with other substances.

Effective Dosage

Not mentioned

Duration

Not mentioned

Interactions

Opioids, stimulants, anticholinergics, and amphetamines were noted as concomitant substances.

Extracted Claims (7)
InterventionDirectionEndpointPopulationDosageImpactClaim #
3,4-Methylenedioxymethamphetamine (MDMA)
neutral
posttraumatic stress and other anxiety related disorders
clinical trials
-
being investigated as an adjunctive treatment
#1
MDMA-assisted therapy
neutral
-
-
-
projected for approval
#2
MDMA
increase
serotonin, norepinephrine, and dopamine signaling
-
-
increasing release and inhibiting reuptake
#3
MDMA
neutral
sympathomimetic physiology
-
-
affects
#4
MDMA-assisted therapy
increase
heart rate and blood pressure
MDMA-assisted therapy sessions
-
transient increases have been observed
#5
concomitant medications and illicit substances (opioids, stimulants, anticholinergics, amphetamines)
neutral
cardiovascular adverse events
-
-
had been previously associated
#6
MDMA
no change
cardiovascular adverse events
17 cases of cardiovascular AEs
-
was not marked as the primary suspect
#7
Abstract

3,4-Methylenedioxymethamphetamine (MDMA) is currently being investigated as an adjunctive treatment to therapy for posttraumatic stress and other anxiety related disorders in clinical trials. Within the next few years MDMA-assisted therapy is projected for approval by regulatory authorities. MDMA's primary mechanism of action includes modulation of monoamine signaling by increasing release and inhibiting reuptake of serotonin, norepinephrine, and, to a lesser extent, dopamine. This pharmacology affects sympathomimetic physiology. In controlled trials, special attention has been given to cardiovascular adverse events (AEs), because transient increases in heart rate and blood pressure have been observed during the MDMA-assisted therapy sessions. Finding and quantifying the potential drivers of cardiac AEs in clinical trials is difficult since only a relatively small number of participants have been included in these studies, and a limited set of allowed concomitant drugs has been studied. In this study a more diverse set of reports from the FDA Adverse Event Reporting System was surveyed. We found 17 cases of cardiovascular AEs, in which the individuals had taken one or more substances in addition to MDMA. Interestingly, all of those concomitant medications and illicit substances, including opioids, stimulants, anticholinergics, and amphetamines, had been previously associated with cardiovascular AEs. Furthermore, in none of the reports MDMA was marked as the primary suspect.

Study Links
Quality Scores
Safety65
Quality70/10
Citation Metrics
Total Citations3
Citations/Year1.5
Relative Citation Ratio0.74
NIH Percentile39.4%
Research Impact Scores
APT Score0.05
Weight Score2.39
Normalized Score0.60
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