Pilot Study Assessing Oral 3,4-Methylenedioxymethamphetamine with Psychotherapy for Moderate-to-Severe Chronic Neuropathic Pain

What this Trial Is About

Researchers are evaluating the use of oral 3,4-methylenedioxymethamphetamine MDMA capsules combined with psychotherapy to treat adults with moderate-to-severe chronic neuropathic pain lasting more than three months. This pilot, phase II, randomized, blinded study aims to assess the feasibility, tolerability, and preliminary effectiveness of MDMA treatment compared to an active placebo. The study also focuses on recruitment, data completion, blinding integrity, and safety to inform a future larger trial. Participants will be randomly assigned to one of two groups. The treatment group receives a single oral dose of 120 mg MDMA capsules with psychological support, plus an optional supplemental 40 mg dose two hours later if tolerated and approved by the physician. The placebo group receives a single dose of 30 mg methylphenidate plus psychological support, with an optional 10 mg supplemental dose at two hours. Both groups undergo preparatory psychotherapy sessions during weeks 1 to 5, a combined dosing and psychotherapy session at week 6, followed by integrative psychotherapy sessions from weeks 7 to 16. Participants also complete home-based psychotherapy modules online. Participants will attend multiple visits for psychotherapy sessions, questionnaires, and adverse event monitoring across the 16-week study period. Assessments include patient-reported pain intensity, physical function, emotional health, and side effects. Data is collected electronically, and the primary clinical endpoint is evaluated at week 16 with final safety follow-up. The total study duration is two years, with each participant involved for 16 weeks from screening to final assessment.

Ecstasy to Alleviate SEvere Chronic Neuropathic Pain Trial