Psychological Effects of Methylenedioxymethamphetamine (MDMA) When Administered to Healthy Volunt… (NCT04073433) | Clinical Trial Compass
WithdrawnPhase 1
Psychological Effects of Methylenedioxymethamphetamine (MDMA) When Administered to Healthy Volunteers (MT-2)
Stopped: Funding
0Started 2024-12
Plain-language summary
The goal of this clinical trial is to study MDMA-assisted therapy in healthy volunteers and provide training of therapists. The main question it aims to answer is:
Does MDMA-assisted therapy result in personal and professional benefits?
Participants will have a non-drug preparatory session prior to each experimental session and an integrative session after each experimental session.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Are learning to conduct MDMA-assisted psychotherapy or MDMA research through the MDMA Therapy Training Program
* Are at least 18 years old
* Are fluent in speaking and reading the predominantly used or recognized language of the study site
* Are able to swallow pills
* Must provide a contact (relative, spouse, close friend or other caregiver) who is willing and able to be reached by the investigator in the event of an emergency or if the participant is unreachable
* Must agree to inform the investigators within 48 hours if any medical conditions occur or medical procedures are planned
* If of childbearing potential, must have a negative pregnancy test at study entry and prior to the Experimental Session, and must agree to use adequate birth control through 10 days after the Experimental Session
* If nursing, must be willing to dispose of breastmilk from dosing through 5 days after each Experimental Session
* Must not participate in any other interventional clinical trials during the duration of the study
* Must agree to not operate a vehicle for at least 24 hours after initial drug administration.
* Must have transportation available after the Experimental Session and through the following day, for traveling back for the Integrative Session.
* Must commit to medication dosing, therapy, and study procedures
* Are willing to be contacted via telephone for all necessary telephone contacts.
Exclusion Criteria:
* Are not able to give adequate informed cons…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from Baseline in Self Compassion Scale (SCS) total score