BridgeMD
Compares treatment options for PTSD
Official title MDMA-assisted Cognitive Processing Therapy Versus Cognitive Processing Therapy for Veterans With Severe Posttraumatic Stress Disorder
ClinicalTrials.gov ID: NCT05837845
What this study is testing
What is MDMA?
MDMA is an investigational medicine, given as an once-daily, being studied as a potential treatment for ptsd.
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
- In partnership with the Veterans Affairs (VA) Palo Alto Health Care System and Stanford University, this study aims to evaluate clinical outcomes, assess implementation feasibility, and health economics of MDMA-assisted Cognitive Processing Therapy (MDMA-aCPT) in the treatment of posttraumatic stress disorder (PTSD). Through a randomized comparison of MDMA-aCPT versus Cognitive Processing Therapy (CPT), a VA gold standard treatment for PTSD, the proposed study will set the stage for understanding the potential use and application of MDMA-aCPT for PTSD within the VA system.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
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
- Participants are eligible to be included in the study only if all of the following criteria apply:
- Are at least 18 years at the time of signing the informed consent
- Are a U.S Military Veteran
- Are receiving services from VA Palo Alto Healthcare System, VA San Francisco Healthcare System, or VA NorCal Healthcare System
- Are fluent in speaking and reading in English
You likely can't join if
- Participants are excluded from the study if any of the following criteria apply:
- Have a history of any medical condition that could make receiving a sympathomimetic drug harmful
- Have current unstable medical illness
- Have cardiac conditions, including uncontrolled hypertension, prolonged QTc interval, and other cardiac conditions
- Have received Electroconvulsive Therapy (ECT), ketamine-assisted therapy, or used ketamine within 12 weeks of enrollment
- Moderate or severe alcohol or cannabis use disorder within the last 12 months
See the full eligibility criteria
- Participants are eligible to be included in the study only if all of the following criteria apply:
- Are at least 18 years at the time of signing the informed consent
- Are a U.S Military Veteran
- Are receiving services from VA Palo Alto Healthcare System, VA San Francisco Healthcare System, or VA NorCal Healthcare System
- Are fluent in speaking and reading in English
- Agree to have study visits audio and/or video recorded
- If assigned to MDMA-aCPT, able to identify appropriate support person(s) to stay with the participant on the evenings of the MDMA sessions
- Meet DSM-5 criteria for PTSD with a symptom duration of at least 6 months
- Have severe PTSD symptoms in the last month
- Body weight of at least 48 kilograms (kg)
- Is not pregnant, planning to get pregnant, or breastfeeding
- Capable of giving signed informed consent
- Participants are excluded from the study if any of the following criteria apply:
- Have a history of any medical condition that could make receiving a sympathomimetic drug harmful
- Have current unstable medical illness
- Have cardiac conditions, including uncontrolled hypertension, prolonged QTc interval, and other cardiac conditions
- Have received Electroconvulsive Therapy (ECT), ketamine-assisted therapy, or used ketamine within 12 weeks of enrollment
- Moderate or severe alcohol or cannabis use disorder within the last 12 months
- Active illicit drug (other than cannabis) or prescription drug substance use disorder at any severity within the last 12 months
- Have current serious suicide risk
- Unable or unwilling to stop or safely taper off prohibited medications
- Have used MDMA (ecstasy) ever
- Currently enrolled in any clinical study
- Personal history of primary psychotic disorder, type I bipolar disorder, severe personality disorder, eating disorder with compensatory behaviors, or depressive disorder with psychotic features
- Lack social support, or lack a stable living situation
The study team makes the final eligibility decision.
Where it's taking place
- Palo Alto, California, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 Palo Alto, California, 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.