OncoMatch/Clinical Trials/NCT05584826
MDMA-assisted Therapy for Adjustment Disorder (AD) in Dyads of Patients With Cancer and a Concerned Significant Other
Is NCT05584826 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies MDMA for cancer.
Treatment: MDMA — The goal of this clinical trial is to assess feasibility, tolerability and preliminary effectiveness of MDMA-assisted therapy for adjustment disorder (AD) in 10 dyads of patients with cancer and a concerned significant other (CSO) (20 participants total). Participants will undergo an 8-week treatment period which will include two doses of MDMA, two Preparatory Sessions and four Integrative Sessions of non-drug therapy.
Check if I qualifyExtracted eligibility criteria
Prior therapy
Cannot have received: cytotoxic chemotherapy
Concurrent or recent (less than four weeks) cytotoxic chemotherapy or radiation therapy, that impairs general level of physical functioning (index participant)
Cannot have received: radiation therapy
Concurrent or recent (less than four weeks) cytotoxic chemotherapy or radiation therapy, that impairs general level of physical functioning (index participant)
Cannot have received: Electroconvulsive Therapy
Have received Electroconvulsive Therapy (ECT) within 12 weeks of enrollment.
Lab requirements
Liver function
No symptomatic liver disease
Cardiac function
No history of ventricular arrhythmia (other than occasional PVCs in the absence of ischemic heart disease); No Wolff-Parkinson-White syndrome or any other accessory pathway not successfully ablated; No history of arrhythmia (other than PACs or occasional PVCs in the absence of ischemic heart disease) within 12 months of screening unless successfully ablated and no recurrence for at least one year off all antiarrhythmic drugs and confirmed by a cardiologist; No significant (controlled or uncontrolled) cardiovascular or coronary disease; No uncontrolled hypertension (AHA criteria: ≥140/90 mmHg on three occasions); Heart rate ≤ 100 bpm on three occasions; No marked baseline prolongation of QT/QTc interval (QTcF >450 ms and >460 ms in females); No history of additional risk factors for Torsade de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome); No use of concomitant medications that prolong the QT/QTc interval during Experimental Sessions.
See exclusion criteria 12-20
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Sunstone Medical, PC · Rockville, Maryland
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