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Psychedelic
MDMA-assisted Therapy for Adjustment Disorder in Cancer Patients
Phase 2
Recruiting
Led By Manish Agrawal, MD
Research Sponsored by Sunstone Medical
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Are able to swallow pills.
Are at least 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks ± 2 days
Awards & highlights
Study Summary
This trial will test if MDMA-assisted therapy could help cancer patients and their significant others cope with AD.
Who is the study for?
This trial is for adult cancer patients with adjustment disorder and their significant others, who speak English, can swallow pills, and agree to study procedures including audio/video recording. Excluded are those with certain heart conditions, severe medical issues, recent heavy MDMA use, or uncontrolled hypertension.Check my eligibility
What is being tested?
The trial tests the effects of MDMA-assisted therapy on pairs consisting of a cancer patient and a close person. Over 8 weeks they'll have two sessions with MDMA and six non-drug therapy sessions to see how well it works for emotional distress from cancer.See study design
What are the potential side effects?
MDMA may cause anxiety, changes in mood or perception, increased heart rate and blood pressure, muscle tension or jaw clenching. Long-term side effects are not fully known but could include memory problems or loss of interest in enjoyable activities.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can swallow pills.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 weeks ± 2 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks ± 2 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To assess the effectiveness of the intervention on Adjustment Disorder and relationship functioning in patients with cancer and a CSO.
Secondary outcome measures
To assess the effect on psychological distress, Mental Adjustment to Cancer (MAC), relationship functioning and health-related quality of life in both patients and their concerned significant other (scale 1)
Adjustment Disorders
Adjustment Disorders
+13 moreSide effects data
From 2018 Phase 1 & 2 trial • 12 Patients • NCT0287617233%
Anxiety
17%
Nasal congestion
17%
Rash
17%
Dyspnoea
17%
Visual Impairment
17%
Vomiting
17%
Upper respiratory tract infection
17%
Arthropod bite
17%
Disturbance in attention
17%
Paresthesia
17%
Oropharyngeal pain
17%
Pruritis
17%
Dizziness
17%
Insomnia
17%
Rhinorrhoea
100%
80%
60%
40%
20%
0%
Study treatment Arm
CSO Patients Open-label CBCT and MDMA-assisted Therapy (up to 2 Months Post Last Experimental Dose)
CSO Patients at 6-month Follow-up
PTSD Patients at 6-month Follow-up
PTSD Patients Open-label CBCT and MDMA-assisted Therapy (up to 2 Months Post Last Experimental Dose)
Trial Design
1Treatment groups
Experimental Treatment
Group I: MDMA-Assisted TherapyExperimental Treatment1 Intervention
Participants will receive 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MDMA
2001
Completed Phase 2
~390
Find a Location
Who is running the clinical trial?
Sunstone MedicalLead Sponsor
1 Previous Clinical Trials
56 Total Patients Enrolled
Manish Agrawal, MDPrincipal InvestigatorSunstone Medical, PC
2 Previous Clinical Trials
250 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had irregular heartbeats but not due to heart disease.I have had low sodium levels or very high body temperature in the past.You have had serious thoughts of hurting yourself or had a plan to do so in the past 6 months.I have a heart condition that hasn't been fixed by a procedure.I am using effective birth control and have a negative pregnancy test.I am currently taking psychiatric medication.I have a spouse or close family member who is key to my well-being.I do not have major health issues that MDMA could worsen, except stable hypothyroidism.I have issues with eating or absorbing food.My heart's electrical cycle is longer than usual.My high blood pressure is well-managed with medication.I have risk factors for a specific heart rhythm issue (like heart failure or low potassium).I need medications that can affect my heart's rhythm during the trial.I can swallow pills.You have or had glaucoma, but you can still participate in the study if an eye doctor says it's okay.I have Type 2 Diabetes that is well-managed and approved by the study doctor.I had heart rhythm problems but was successfully treated over a year ago without recurrence.I have not had Electroconvulsive Therapy in the last 3 months.I am unable to understand or sign the consent form.I am 18 years old or older.I have Hepatitis C but it doesn't cause symptoms and I've been treated for it.I haven't had chemotherapy or radiation in the last 4 weeks that worsened my physical ability.I have hypothyroidism but am on a stable thyroid medication.You have used a drug called Ecstasy (also known as MDMA) more than 10 times in the past 10 years, or at least once within 6 months before the start of the study.You have a history of or currently have a serious mental health condition that affects your thinking or mood.I have had an irregular heartbeat, not caused by PACs or occasional PVCs, in the last year.You are allergic to any ingredient in the study medication.Your heart beats faster than 100 times per minute on three different occasions.I weigh less than 48 kg.I have symptoms caused by liver problems.I agree to follow specific lifestyle changes, including fasting, medication rules, and not joining other trials.
Research Study Groups:
This trial has the following groups:- Group 1: MDMA-Assisted Therapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What evidence is there that MDMA-Assisted Therapy poses minimal risk to participants?
"Considering the relative lack of clinical data supporting its efficacy, MDMA-Assisted Therapy was rated a 2 on our internal scale. However, there is still evidence that it can be relatively safe to use in this situation."
Answered by AI
How many total volunteers have enrolled in this trial?
"Affirmative, the information hosted on clinicaltrials.gov suggests that this trial is actively seeking patients and has been since October 6th 2022. This project was last reviewed on October 13th 2022 and aims to incorporate 20 individuals across a single medical site."
Answered by AI
Are there any vacancies for participants in this clinical experiment?
"As attested to by clinicaltrials.gov, this medical trial is welcoming volunteers. The study was launched on October 6th 2022 and the information has been amended as recently as October 13th 20202."
Answered by AI
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