BridgeMD
New treatment option for Mental Wellbeing
Official title MDMA-Assisted Therapy for Mental Healthcare Providers
ClinicalTrials.gov ID: NCT07102576
What this study is testing
What is MDMA Hydrochloride?
MDMA Hydrochloride is an investigational medicine, being studied as a potential treatment for mental wellbeing.
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
- This is a phase 1, open-label study to assess changes in mental well-being following MDMA administration within a therapeutic setting, in mental health providers who are in training to become MDMA assisted therapists. Secondary outcome measures will examine the effects on provider burnout, provider self-efficacy, mood, self-compassion, quality of life, and other psychological factors.
- Phase 1: an early, usually small safety study
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. Healthy volunteers may be eligible.
You may be able to join if
- Are at least 18 years at the time of signing the informed consent.
- Fluent in English
- Able to swallow pills
- Agree to have study visits audiovisually recorded
- Able to provide a contact (relative, spouse, close friend, or other support person) who is willing and able to be reached by the investigators in the...
You likely can't join if
- Have engaged in a new form of psychiatric or mental health care within 12 weeks of enrollment
- Have a current alcohol or cannabis use disorder of any severity within the 12 months prior to enrollment
- Have a substance use disorder of any severity within 12 months prior to enrollment
- Any suicidal ideation within the last 6 months
- Repetitive or recent use of Ecstasy/MDMA
- Current enrollment in any other clinical study involving an investigational study treatment or any other type of medical research, unless approved by...
See the full eligibility criteria
- Are at least 18 years at the time of signing the informed consent.
- Fluent in English
- Able to swallow pills
- Agree to have study visits audiovisually recorded
- Able to provide a contact (relative, spouse, close friend, or other support person) who is willing and able to be reached by the investigators in the event of the participant becoming unwell or unreachable.
- Must be licensed, license-eligible, or trainees in a relevant healthcare/mental health profession
- Must be learning or have been certified to conduct MDMA-assisted therapy through the Lykos MDMA-Assisted Therapy Training program or authorized affiliate program
- Body weight of at least 45 kilograms (kg; or 100 pounds (lbs)).
- Have engaged in a new form of psychiatric or mental health care within 12 weeks of enrollment
- Have a current alcohol or cannabis use disorder of any severity within the 12 months prior to enrollment
- Have a substance use disorder of any severity within 12 months prior to enrollment
- Any suicidal ideation within the last 6 months
- Repetitive or recent use of Ecstasy/MDMA
- Current enrollment in any other clinical study involving an investigational study treatment or any other type of medical research, unless approved by the study clinician
- Meet diagnostic criteria for a Major Depressive Episode currently or within the prior 3 months or meet diagnostic criteria for a current anxiety disorder assessed
- Have a current eating disorder with compensatory behaviors
- Have a history of, or a current primary psychotic disorder or bipolar disorder
- Previous participation in a clinical trial that included administration of MDMA
- Individuals in a personal relationship with the site investigator
- Are pregnant or nursing or are able to become pregnant and are not practicing an effective means of contraception
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, 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. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, 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.