Actively Recruiting
MDMA-assisted Therapy for Adjustment Disorder (AD) in Dyads of Patients With Cancer and a Concerned Significant Other
Led by Sunstone Medical · Updated on 2026-05-04
20
Participants Needed
1
Research Sites
316 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
MDMA-assisted Therapy for Adjustment Disorder (AD) in Dyads of Patients With Cancer and a Concerned Significant Other
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Are at least 18 years old
- Are considered important to the patient's well-being (e.g., spouse or close family member)
- Meet DSM-5 criteria for current adjustment disorder without other mental disorders or normal bereavement
- Score 47.5 or higher on the ADNM-2020 diagnostic scale for adjustment disorder
- Are able to swallow pills
- Agree to be driven home after experimental sessions and not drive until deemed safe
- If able to become pregnant, have a negative pregnancy test before sessions and agree to use effective birth control
- Agree to inform investigators within 48 hours of any medical conditions or procedures
- Are proficient in speaking and reading English
- Agree to have all clinic visits recorded by audio and video
- Agree to lifestyle modifications including fasting and medication restrictions before sessions
- May have well-controlled hypertension if cardiovascular disease is ruled out
- May have treated asymptomatic Hepatitis C
- May have alcohol or substance use disorder if not in withdrawal and with a plan to reduce use
- May have stable Type 2 Diabetes Mellitus with physician approval
- May have hypothyroidism if on stable thyroid medication
- May have glaucoma with ophthalmologist approval
You will not qualify if you...
- Receiving cytotoxic chemotherapy or radiation therapy within 4 weeks impairing physical functioning
- Weigh less than 48 kg
- Condition impairing oral intake or digestive absorption
- Unable to give informed consent
- Significant suicide risk with intent and plan in past 6 months or at screening
- Any current problem interfering with participation as judged by investigators
- Present serious risk to others
- History or current primary psychotic disorder, major depressive disorder with psychotic features, bipolar type 1, or dissociative identity disorder
- Require ongoing psychiatric medication except as allowed
- Electroconvulsive Therapy within past 12 weeks
- Used Ecstasy (MDMA) more than 10 times in last 10 years or within 6 months
- History of ventricular arrhythmia except occasional PVCs without ischemic disease
- Wolff-Parkinson-White syndrome or other accessory pathway not ablated
- History of arrhythmia within 12 months unless successfully treated and stable
- Significant hematological, endocrine, cerebrovascular, cardiovascular, pulmonary, renal, gastrointestinal, immunocompromising, neurological disease, or seizure disorder
- Uncontrolled hypertension (blood pressure ≥140/90 mmHg on 3 occasions)
- Heart rate over 100 bpm on 3 occasions
- Marked prolonged QT/QTc interval as defined
- Additional risk factors for Torsade de pointes
- Use of medications prolonging QT/QTc interval during sessions
- Symptomatic liver disease
- History of hyponatremia or hyperthermia
- Pregnant, nursing, or able to become pregnant without effective birth control
- Hypersensitivity to any ingredient of the investigational product
AI-Screening
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Trial Site Locations
Total: 1 location
1
Sunstone Medical, PC
Rockville, Maryland, United States, 20850
Actively Recruiting
Research Team
S
Study Contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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