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NCT05584826 · ClinicalTrials.gov registry record · Phase 2
MDMA-assisted Therapy for Adjustment Disorder (AD) in Dyads of Patients With Cancer and a Concerned Significant Other
A Phase 2 study of Cancer and Adjustment Disorders, sponsored by Sunstone Medical.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT05584826: Recruiting Phase 2 study of Cancer and Adjustment Disorders, sponsored by Sunstone Medical.
NCT05584826 is a Phase 2 study of Cancer and Adjustment Disorders that is actively recruiting participants, run by Sunstone Medical. The registered enrollment target is 20 participants, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05584826, a Phase 2 study of Cancer and Adjustment Disorders, is actively recruiting participants, sponsored by Sunstone Medical.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
The study will assess participants scores on The Adjustment Disorder New Module - 20 items (ADNM-20) from baseline to the primary time point (Visit 10, week 8 ± 2 days).
Conditions Studied
Interventions
- DRUG MDMA
Study Locations (1)
Maryland
- Sunstone Medical, PC - Rockville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2022-10-06 |
| Est. Completion | 2025-12 |
| Phase | Phase 2 |
What NCT05584826 shows while recruiting
NCT05584826 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (99% lower).
The record links to 2 conditions, with Cancer appearing as the primary indexed condition, and to 1 intervention - of which MDMA is the first listed.
NCT05584826 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT05584826 about?
NCT05584826 is a clinical study titled "MDMA-assisted Therapy for Adjustment Disorder (AD) in Dyads of Patients With Cancer and a Concerned Significant Other". 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 treatme...
What is the current status of trial NCT05584826?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2022-10-06. Estimated completion is 2025-12.
What conditions does trial NCT05584826 study?
This clinical trial studies the following conditions: Cancer, Adjustment Disorders.
What interventions are being tested in trial NCT05584826?
The interventions under investigation include: MDMA (DRUG).
Who is sponsoring clinical trial NCT05584826?
This trial is sponsored by Sunstone Medical, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05584826 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05584826's enrollment target sits among peer trials
20 561st of 615 higher than 47 of 615 other Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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