Prospective preference assessment for the Ecstasy for Alleviating Severe Chronic Neuropathic Pain (EASE-Pain) trial.

Abstract

Purpose: Emerging evidence suggests that 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy may be a promising intervention for chronic pain. We designed the Ecstasy for Alleviating Severe Chronic Neuropathic Pain (EASE-Pain) trial, a randomized controlled trial comparing MDMA with an active placebo (methylphenidate) for pain relief. We sought to conduct a prospective preference assessment (PPA) prior to the trial, with the objectives to 1) assess willingness to participate in the trial, 2) identify participants' motivations and concerns to enhance enrolment and acceptability, and 3) compare demographic and health characteristics between willing and nonwilling participants.

Methods: We recruited patients from the St. Michael's Hospital Pain Clinic (Toronto, ON, Canada) from July to August 2024. Each participant completed four PPA phases: 1) a trial description, 2) comprehension assessment, 3) open-ended questions exploring attitudes towards the trial, and 4) a self-administered questionnaire. We analyzed data qualitatively using thematic analysis and quantitatively using t tests and Fisher's exact test.

Results: We enrolled 42 patients, with 76% willing and 24% not willing to participate in the EASE-Pain trial. White/European participants were more likely to be willing than not willing to participate (78% vs 40%; P < 0.001). Motivating factors for participation included pain relief (62%) and seeking alternatives to ineffective treatments (26%). Common concerns included side effects (43%), impacts on comorbidities (19%), and the stigma of MDMA (19%).

Conclusions: The results of this study indicate a strong willingness among patients with chronic pain to participate in the EASE-Pain trial. Primary concerns included side effects and impacts on comorbidities. In response, protocol modifications, including improved patient education on study drug effects, will be implemented.