Issues in Clinical Trial Design—Lessons From the FDA’s Rejection of MDMA
Samuel T. Wilkinson, Gerard Sanacora
Abstract
This Viewpoint explores potential justifications underlying the US Food and Drug Administration (FDA)’s rejection of methylenedioxymethamphetamine (MDMA) as a treatment for posttraumatic stress disorder, including lack of blinding and issues around the integrity of relevant clinical trials.
Topics & Concepts
MDMAFood and drug administrationClinical trialBlindingMedicineClinical researchPsychiatryPsychologyPharmacologyInternal medicinePain Management and Placebo EffectComplementary and Alternative Medicine StudiesPsychedelics and Drug Studies