RecruitingPhase 2NCT05584826

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


Sponsor

Sunstone Medical

Enrollment

20 participants

Start Date

Oct 6, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called MDMA for people with adjustment disorders and cancer. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMDMA

On 2 separate treatment visits, participants will receive dosing of 100 mg MDMA HCl (\~84 mg MDMA) + 40 mg MDMA HCl (\~34 mg MDMA) supplement unless tolerability issues arise from the first dose or the participant declines


Locations(1)

Sunstone Medical, PC

Rockville, Maryland, United States

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NCT05584826


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