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Clinical Trial 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.


Clinical Trial Description

This open-label single site concurrent mixed-method phase 2 pilot trial will assess the 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). The intervention will include two doses of MDMA, administered during the Treatment Period with manualized therapy. This 8-week Treatment Period includes two Preparatory Sessions and four Integrative Sessions of non-drug therapy. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05584826
Study type Interventional
Source Sunstone Medical
Contact Manish Agrawal, MD
Phone 301-750-3401
Email dyadstudy@sunstonetherapies.com
Status Recruiting
Phase Phase 2
Start date October 6, 2022
Completion date December 2024

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