Grant: Project Grant

Chronic neuropathic pain (CNP) is a severe, disabling chronic pain condition that greatly impacts both physical and mental health, affecting at least 1 in 10 Canadians, of whom 17% rate their symptoms as 'worse than death'. The economic impact to Canadians is estimated to be $60 billion each year. Current medications only provide modest relief in up to 50% of patients. Other traditional treatments like Cognitive Behavioral Therapy and Mindfulness-Based Meditation (CBT/MM) are effective but can take over a year to show benefits and often lack patient engagement. MDMA (the active component in 'ecstasy'), when combined with CBT/MM (i.e. MDMA Assisted Psychotherapy [MDMA-AT]) has demonstrated rapid onset of pain relief (weeks, not months) but patients and regulators have concerns about the biased design of these trials, in which too many patients correctly guessed their treatment assignment. Thus, we propose a randomized, methylphenidate-controlled (active-placebo) clinical trial evaluating the feasibility of combining an acute course of MDMA with CBT/MM to reduce pain interference in patients with CNP. 40 participants will be randomized 1:1 to receive MDMA or methylphenidate (2 experimental sessions over 16 weeks) with both arms enrolled in an evidence-based 16-week CBT/MM intervention. Our feasibility outcomes will include rates of recruitment, data completion, and participant retention as well safety, blinding integrity, and barriers/facilitators to a full trial (patient acceptability). As this is an internal pilot trial, all outcome data (i.e. pain interference) will transfer unanalyzed to a larger, full-scale trial if feasibility metrics are met. This study will be the first to evaluate combining MDMA with CBT/MM and is also one of the only such trials looking at CNP. If combining MDMA with CBT/MM is found to be safe and effective, this novel intervention could greatly improve quality of life and reduce pain-related disability for this marginalized population.