drugset / Trial / NCT05584826

MDMA-assisted Therapy for Adjustment Disorder (AD) in Dyads of Patients With Cancer and a Concerned Significant Other

NCT05584826 ↗

Phase 2 Recruiting 20 enrolled Sunstone Medical
NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2022-10-06
Primary completion
2026-10
Completion
2028-11

Drugs

EvaluationDrugModalityDoseRoute
Subject 3,4-methylenedioxymethamphetamine (MDMA) Unknown 40 mg —
Subject 3,4-methylenedioxymethamphetamine (MDMA) Unknown 100 mg —