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New treatment option for Cancer
Official title MDMA-assisted Therapy for Adjustment Disorder (AD) in Dyads of Patients With Cancer and a Concerned Significant Other
ClinicalTrials.gov ID: NCT05584826
What this study is testing
What is MDMA?
MDMA is an investigational medicine, being studied as a potential treatment for cancer.
Also referred to as 3,4-methylenedioxymethamphetamine (MDMA).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Are at least 18 years old
- Are considered important to their well-being by patient participants (e.g., spouse or close family member)
- Meet DSM-5 criteria for current AD (no criteria for another mental disorder and does not correspond to an exacerbation of a preexisting mental...
- Satisfies diagnostic criteria for AD using the ADNM-2020 (score ≥ 47.5 on the scale)
- Are able to swallow pills.
You likely can't join if
- Concurrent or recent (less than four weeks) cytotoxic chemotherapy or radiation therapy, that impairs general level of physical functioning (index...
- Weigh less than 48 kg
- Condition impairing oral intake or digestive absorption
- Are not able to give adequate informed consent
- Significant suicide risk as defined by suicidal ideation with intend and a plan as endorsed on items 5 on the C-SSRS within the past 6 months or at...
- Have any current problem which, in the opinion of the investigator or study physician, might interfere with participation
See the full eligibility criteria
Who can join
- Are at least 18 years old
- Are considered important to their well-being by patient participants (e.g., spouse or close family member)
- Meet DSM-5 criteria for current AD (no criteria for another mental disorder and does not correspond to an exacerbation of a preexisting mental disorder. Does not represent a normal bereavement)
- Satisfies diagnostic criteria for AD using the ADNM-2020 (score ≥ 47.5 on the scale)
- Are able to swallow pills.
- Are willing to be driven home after the experimental sessions, either by a driver arranged by the participant or by the site personnel or taxi and agree not to drive after each Experimental Session until the therapists...
- If able to become pregnant (i.e. assigned female at birth, fertile, following menarche and until becoming post-menopausal unless permanently sterile), must have a highly sensitive negative pregnancy test at study entry...
- Must agree to inform the Clinical Investigators within 48 hours of any medical conditions and procedures
- Are proficient in speaking and reading English
- Agree to have all clinic visit sessions recorded to audio and video
- Agree to the following lifestyle modifications (described in more detail in Section 4.3 Lifestyle Modifications): comply with requirements for fasting and refraining from certain medications prior to Experimental...
- May have well-controlled hypertension that has been successfully treated with anti-hypertensive medicines, if they pass additional screening to rule out underlying cardiovascular disease.
- May have asymptomatic Hepatitis C virus (HCV) that has previously undergone evaluation and treatment as needed.
- May have alcohol or substance use disorder if participant is not in withdrawal or requiring detox. Participants must have a plan, agreed upon by investigator, therapy team, and study physician, to reduce use of alcohol...
- May have a history of or current Diabetes Mellitus (Type 2) if additional screening measures rule out underlying cardiovascular disease, if the condition is judged to be stable on effective management, and with approval...
- May have hypothyroidism if taking adequate and stable thyroid replacement medication.
- May have a history of, or current, glaucoma if approval for study participation is received from an ophthalmologist.
What rules you out
- Concurrent or recent (less than four weeks) cytotoxic chemotherapy or radiation therapy, that impairs general level of physical functioning (index participant)
- Weigh less than 48 kg
- Condition impairing oral intake or digestive absorption
- Are not able to give adequate informed consent
- Significant suicide risk as defined by suicidal ideation with intend and a plan as endorsed on items 5 on the C-SSRS within the past 6 months or at V0 (see Appendix A)
- Have any current problem which, in the opinion of the investigator or study physician, might interfere with participation
- Would present a serious risk to others as established through clinical interview and contact with treating psychiatrist.
- Have a history of, or a current primary psychotic disorder, major depressive disorder with psychotic features, bipolar affective disorder type 1 or history of or current dissociative identity disorder
- Require ongoing concomitant therapy with a psychiatric medication with exceptions described in Section 8.0: Concomitant Medications.
- Have received Electroconvulsive Therapy (ECT) within 12 weeks of enrollment.
- Have used Ecstasy (material represented as containing MDMA) more than 10 times within the last 10 years or at least once within 6 months of the first Experimental Session;
- Have a history of ventricular arrhythmia at any time, other than occasional premature ventricular contractions (PVCs) in the absence of ischemic heart disease.
- Have Wolff-Parkinson-White syndrome or any other accessory pathway that has not been successfully eliminated by ablation.
- Have a history of arrhythmia, other than premature atrial contractions (PACs) or occasional PVCs in the absence of ischemic heart disease, within 12 months of screening. Participants with a history of atrial...
- Have evidence or history of significant (controlled or uncontrolled) hematological, endocrine, cerebrovascular, cardiovascular, coronary, pulmonary, renal, gastrointestinal, immunocompromising, or neurological disease...
- Have uncontrolled hypertension using the standard criteria of the American Heart Association (values of 140/90 milligrams of Mercury [mmHg] or higher assessed on three separate occasions)
- Have a heart rate \> 100 bpm on three separate occasions
- Have a marked Baseline prolongation of QT/QTc interval (For purposes of eligibility, this is defined as repeated demonstration of a QT interval corrected using Fridericia's formula [QTcF] \>450 milliseconds [ms] and...
- Have a history of additional risk factors for Torsade de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
- Require use of concomitant medications that prolong the QT/QTc interval during Experimental Sessions. Refer to Section 12.0 Concomitant Medications.
- Have symptomatic liver disease
- Have history of hyponatremia or hyperthermia
- Are pregnant, nursing, or able to become pregnant and are not practicing an effective means of birth control.
- Have hypersensitivity to any ingredient of the IMP (Investigational Medicinal Product).
The study team makes the final eligibility decision.
Where it's taking place
- Rockville, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rockville, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.