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MDMA-Assisted Therapy for PTSD (MDMA-bCBCT Trial)
Phase 3
Recruiting
Led By Leslie Morland
Research Sponsored by Dr. Leslie Morland
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline - 6 months post-treatment
Awards & highlights
MDMA-bCBCT Trial Summary
This trial aims to see if MDMA can help veterans with PTSD and their relationships.
Who is the study for?
This trial is for veterans with PTSD and their partners who've been together for at least a year. Participants must speak English, commit to the study schedule, not start new mental health care during the trial, and agree to lifestyle changes. Women able to get pregnant must use birth control. Exclusions include severe relationship aggression, high risk of re-trauma or lack of support, certain psychiatric conditions or substance abuse issues.Check my eligibility
What is being tested?
The study tests if MDMA can help improve PTSD symptoms and relationship functioning when combined with brief cognitive behavioral conjoint therapy (bCBCT). Veterans with PTSD and their partners will undergo this combination treatment within the VA San Diego Healthcare System.See study design
What are the potential side effects?
MDMA may cause side effects like anxiety, mood swings, sleep disturbances, appetite loss, physical discomforts such as muscle tension or nausea; it can also increase heart rate and blood pressure which might be risky for those with certain medical conditions.
MDMA-bCBCT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline - 6 months post-treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline - 6 months post-treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clinician-rated PTSD symptoms
Secondary outcome measures
Relationship satisfaction
Other outcome measures
Adverse childhood events
Depressive symptoms
Emotion regulation
+9 moreMDMA-bCBCT Trial Design
1Treatment groups
Experimental Treatment
Group I: Non-medicine sessions of bCBCT + Medicine Sessions with 3,4-methyllenedioxymethamphetamine (MDMA)Experimental Treatment2 Interventions
bCBCT Non-medicine sessions: 8 sessions
MDMA Medicine sessions:
Initial Dose 1: 80 mg MDMA HCl (~68 mg MDMA) Supplementary Dose 1: 40 mg MDMA HCl (~34 mg MDMA) Initial Dose 2: 100 mg MDMA HCl (~84 mg MDMA) Supplementary Dose 2: 40 mg MDMA HCl (~34 mg MDMA)
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Who is running the clinical trial?
MAPS Public Benefit CorporationIndustry Sponsor
29 Previous Clinical Trials
1,286 Total Patients Enrolled
Healing BreakthroughUNKNOWN
1 Previous Clinical Trials
10 Total Patients Enrolled
Dr. Leslie MorlandLead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a veteran with PTSD and have had ECT in the last 12 weeks.I need medications that may affect my heart's rhythm during the trial.I agree to fast and stop certain medications before MDMA sessions.I have high blood pressure that is not well-controlled.I have been diagnosed with major depression with psychosis.I am a veteran with PTSD and need to continue my psychiatric medication.I weigh less than 48 kg.I have liver problems or high liver enzyme levels.My partner and I agree not to start new mental health care during the trial without consulting the study's lead.I have had low sodium levels or very high body temperature before.I have Wolff-Parkinson-White syndrome or a similar condition not treated with ablation.I am a veteran over 18 with PTSD or the partner of one without PTSD.I have used ketamine or had ketamine therapy in the last 3 months.I can use two forms of birth control if I can get pregnant and will test for pregnancy.I have risk factors for a specific heart rhythm issue (like heart failure or low potassium).I have had a heart rhythm problem, but it's been stable for over a year without medication.I have a condition that affects my kidney function.I can keep my current mental health care if it's not for PTSD or couples therapy, and it doesn't change in frequency.I have had irregular heartbeats but not due to heart disease.I do not have a condition that worsens with increased blood pressure or heart rate.
Research Study Groups:
This trial has the following groups:- Group 1: Non-medicine sessions of bCBCT + Medicine Sessions with 3,4-methyllenedioxymethamphetamine (MDMA)
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Has the FDA approved the integration of psychotherapy with 3,4-methyllenedioxymethamphetamine (MDMA) for medical treatment?
"Based on our evaluation, the safety of Non-medicine sessions of bCBCT + Medicine Sessions with 3,4-methyllenedioxymethamphetamine (MDMA) was assessed as a 3. This is due to sufficient clinical evidence that demonstrates its efficacy and multiple measures taken to ensure patient safety."
Answered by AI
Are there any vacancies to participate in this clinical trial?
"The most up-to-date information from clinicaltrials.gov confirms that this trial is no longer searching for patients, having been last updated on July 31st 2023. Despite its conclusion, 399 other trials are still actively recruiting participants."
Answered by AI
Who else is applying?
What site did they apply to?
VA San Diego Healthcare System, San Diego, CA
What portion of applicants met pre-screening criteria?
Met criteria
Why did patients apply to this trial?
I have struggled with PTSD for years and have done several trials nothing seems to help and it impacts my life on a daily basis.
PatientReceived no prior treatments
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