Trial Title:
MDMA-assisted Therapy for Adjustment Disorder (AD) in Dyads of Patients With Cancer and a Concerned Significant Other
NCT ID:
NCT05584826
Condition:
Cancer
Adjustment Disorders
Conditions: Official terms:
Adjustment Disorders
N-Methyl-3,4-methylenedioxyamphetamine
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
MDMA
Description:
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
Arm group label:
MDMA-Assisted Therapy
Other name:
3,4-methylenedioxymethamphetamine (MDMA)
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.
Detailed description:
This open-label single site concurrent mixed-method phase 2 pilot trial will assess the
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). The intervention will include two doses of MDMA,
administered during the Treatment Period with manualized therapy. This 8-week Treatment
Period includes two Preparatory Sessions and four Integrative Sessions of non-drug
therapy.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Are at least 18 years old
2. Are considered important to their well-being by patient participants (e.g., spouse
or close family member)
3. 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)
4. Satisfies diagnostic criteria for AD using the ADNM-2020 (score ≥ 47.5 on the scale)
5. Are able to swallow pills.
6. 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 deem it safe to do so
7. 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 and prior to each
Experimental Session, and must agree to use adequate birth control through 10 days
after the last Experimental Session. Adequate birth control methods include
intrauterine device (IUD), injected, implanted, intravaginal, or transdermal
hormonal methods, abstinence, oral hormones plus a barrier contraception,
vasectomized sole partner, or double barrier contraception. Two forms of
contraception are required with any barrier method or oral hormones (i.e. condom
plus diaphragm, condom or diaphragm plus spermicide, oral hormonal contraceptives
plus spermicide or condom).
8. Must agree to inform the Clinical Investigators within 48 hours of any medical
conditions and procedures
9. Are proficient in speaking and reading English
10. Agree to have all clinic visit sessions recorded to audio and video
11. 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 Sessions, not enroll in any other
interventional clinical trials during the duration of the study, be driven home
after each Experimental Session, and commit to medication dosing, therapy, and study
procedures.
12. 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.
13. May have asymptomatic Hepatitis C virus (HCV) that has previously undergone
evaluation and treatment as needed.
14. 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 or other substances and to
manage symptoms without self-medicating. Enrollment will require that, in the
judgment of the investigator, therapy team, and study physician, the plan for
decreasing substance use is realistic and has a good chance of succeeding in order
to prevent substance use from impacting the safety or efficacy of the
investigational treatment.
15. 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 by the study physician.
16. May have hypothyroidism if taking adequate and stable thyroid replacement
medication.
17. May have a history of, or current, glaucoma if approval for study participation is
received from an ophthalmologist.
Exclusion Criteria:
1. Concurrent or recent (less than four weeks) cytotoxic chemotherapy or radiation
therapy, that impairs general level of physical functioning (index participant)
2. Weigh less than 48 kg
3. Condition impairing oral intake or digestive absorption
4. Are not able to give adequate informed consent
5. 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)
6. Have any current problem which, in the opinion of the investigator or study
physician, might interfere with participation
7. Would present a serious risk to others as established through clinical interview and
contact with treating psychiatrist.
8. 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
9. Require ongoing concomitant therapy with a psychiatric medication with exceptions
described in Section 8.0: Concomitant Medications.
10. Have received Electroconvulsive Therapy (ECT) within 12 weeks of enrollment.
11. 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;
12. Have a history of ventricular arrhythmia at any time, other than occasional
premature ventricular contractions (PVCs) in the absence of ischemic heart disease.
13. Have Wolff-Parkinson-White syndrome or any other accessory pathway that has not been
successfully eliminated by ablation.
14. 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 fibrillation, atrial tachycardia, atrial
flutter or paroxysmal supraventricular tachycardia or any other arrhythmia
associated with a bypass tract may be enrolled only if they have been successfully
treated with ablation and have not had recurrent arrhythmia for at least one year
off all antiarrhythmic drugs, and confirmed by a cardiologist.
15. Have evidence or history of significant (controlled or uncontrolled) hematological,
endocrine, cerebrovascular, cardiovascular, coronary, pulmonary, renal,
gastrointestinal, immunocompromising, or neurological disease, including seizure
disorder, or any other medical disorder judged by the investigator to significantly
increase the risk of MDMA administration (participants with hypothyroidism who are
on adequate and stable thyroid replacement will not be excluded). Note: if
participants present with a history of glaucoma, enrollment would be allowed only
with the approval of their ophthalmologist
16. 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)
17. Have a heart rate > 100 bpm on three separate occasions
18. 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 >460 ms in females. For
transgender or non-binary participants, QTc interval will be evaluated based on sex
assigned at birth, unless the participant has been on hormonal treatment for five or
more years.
19. Have a history of additional risk factors for Torsade de pointes (e.g., heart
failure, hypokalemia, family history of Long QT Syndrome)
20. Require use of concomitant medications that prolong the QT/QTc interval during
Experimental Sessions. Refer to Section 12.0 Concomitant Medications.
21. Have symptomatic liver disease
22. Have history of hyponatremia or hyperthermia
23. Are pregnant, nursing, or able to become pregnant and are not practicing an
effective means of birth control.
24. Have hypersensitivity to any ingredient of the IMP (Investigational Medicinal
Product).
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Sunstone Medical, PC
Address:
City:
Rockville
Zip:
20850
Country:
United States
Status:
Recruiting
Contact:
Last name:
Celia Leeks
Phone:
301-750-3401
Email:
dyadstudy@sunstonetherapies.com
Investigator:
Last name:
Manish Agrawal, MD
Email:
Principal Investigator
Start date:
October 6, 2022
Completion date:
December 2024
Lead sponsor:
Agency:
Sunstone Medical
Agency class:
Other
Source:
Sunstone Medical
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05584826
