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

NCT05584826 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-05-04

No results posted yet for this study

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.

Conditions

Interventions

DRUG

MDMA

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

Sponsors & Collaborators

  • Sunstone Medical

    lead OTHER

Principal Investigators

  • Manish Agrawal, MD · Sunstone Medical, PC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-06
Primary Completion
2026-10-31
Completion
2028-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05584826 on ClinicalTrials.gov