Too big to fail? Comparing effect sizes of MDMA assisted therapy to unmasking bias
Study at a glance
AI-extracted from the abstract| Characteristics | Theoretical or quantitative analysis |
|---|---|
| Topics | MDMA |
| Key points | Argues that unmasking bias is larger than the treatment versus control effect size for MDMA, suggesting that MDMA-AT's effect sizes are not too large to be due to unmasking. |
Abstract
On August 9th the US Food and Drug Administration’s (FDA) rejected 3,4-methylenedioxymethamphetamine assisted therapy (MDMA-AT) as a treatment for post-traumatic stress disorder (PTSD), despite seemingly positive trial results. A major reason cited was functional unmasking, which combined with enthusiasm about MDMA, raised concerns about the objectivity of these trials. Here, we define what is 'unmasking bias' and calculate its magnitude for two drugs, ketamine and escitalopram, where data was available from the literature. Our results show that unmasking bias is larger than the treatment vs control effect size for MDMA. These findings do not prove that effects of MDMA-AT are entirely or even partially due to unmasking, however, our findings do indicate that MDMA-AT’s effect sizes are not too large to be due to unmasking.
Comparable studies
Other theoretical and historical papers on MDMA, most cited first.
| Study | Year | Design | Participants |
|---|---|---|---|
| Differences Between the Mechanism of Action of MDMA, MBDB, and the Classic Hallucinogens. Identification of a New Therapeutic Class: Entactogens | 1986 | Theoretical or philosophical paper | |
| The Background and Chemistry of MDMA | 1986 | Historical analysis | |
| The origin of MDMA (ecstasy) revisited: the true story reconstructed from the original documents* Original documents in Merck's historical archive in Darmstadt, Germany, years 1900–1960 | 2006 | Historical analysis | |
| Distinct neural mechanisms for the prosocial and rewarding properties of MDMA | 2019 | Theoretical or philosophical paper | |
| How could MDMA (ecstasy) help anxiety disorders? A neurobiological rationale | 2009 | Theoretical or philosophical paper |