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Psychedelic
MDMA-Assisted Psychotherapy for PTSD (VALLMDMA_001 Trial)
Phase 2
Recruiting
Led By Shannon Remick, MD
Research Sponsored by VA Loma Linda Health Care System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants must be 18-55 years old
Participants must be 18-55 years old.
Must not have
Any person unable to give adequate informed consent
People weighing less than 50 kg
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 2 months, 12-months follow-up
Awards & highlights
Summary
This trial is designed to test the feasibility of administering MDMA in conjunction with psychotherapy for combat-related treatment-resistant PTSD in US military veterans.
Who is the study for?
This trial is for US military veterans aged 18-55 with combat-related PTSD that hasn't improved after treatment, enrolled in VA healthcare. They must be generally healthy, not on psychiatric meds (or willing to stop them safely), and agree to avoid alcohol before sessions and certain medications during the study. Pregnant women or those at serious suicide risk are excluded.
What is being tested?
The trial tests MDMA-assisted psychotherapy's effectiveness for veterans with refractory PTSD over a 12-week period, including three single-dose sessions paired with therapy. The main goal is symptom reduction or remission measured by the Clinician-Administered PTSD Scale (CAPS-5).
What are the potential side effects?
Possible side effects of MDMA may include anxiety, mood changes, headache, fatigue, muscle tension, insomnia, nausea and potential increase in heart rate or blood pressure.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 55 years old.
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I am between 18 and 55 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am able to understand and agree to the study's requirements.
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I weigh less than 50 kg.
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I am not pregnant, nursing, and I use effective birth control.
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I am currently in therapy for PTSD.
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I have major depression with psychotic symptoms.
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I have undergone ECT within the last 3 months.
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I need medications that may affect my heart's rhythm during the trial.
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I have had low sodium levels or very high body temperature in the past.
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I am currently taking medication for my mental health.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 2 months, 12-months follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 2 months, 12-months follow-up
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in total score of CAPS-5
Trial Design
1Treatment groups
Experimental Treatment
Group I: Open LabelExperimental Treatment1 Intervention
Participants will receive an initial dose of 80 mg of 3,4-methylenedioxymethamphetamine (MDMA) and an optional supplemental dose of 40 mg MDMA during the first Experimental Session. In the second and third Experimental Sessions, the participant will receive an initial dose of 120 mg MDMA and an optional supplemental dose of 40 mg MDMA.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Midomafetamine
Not yet FDA approved
Find a Location
Who is running the clinical trial?
Lykos TherapeuticsOTHER
41 Previous Clinical Trials
1,265 Total Patients Enrolled
VA Loma Linda Health Care SystemLead Sponsor
9 Previous Clinical Trials
765 Total Patients Enrolled
Multidisciplinary Association for Psychedelic StudiesOTHER
39 Previous Clinical Trials
1,239 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have severe health issues like heart, lung, liver diseases, or immune problems.I am generally healthy with no major health issues.I am able to understand and agree to the study's requirements.You have a history of or currently have certain mental health conditions like psychosis, dissociation, bipolar disorder, or personality disorders.You have a problem with using drugs or alcohol, except for caffeine or nicotine.I weigh less than 50 kg.I can avoid alcohol for 3 days before each MDMA session without withdrawal risks.You have experienced trauma related to combat and have been diagnosed with post-traumatic stress disorder (PTSD) according to specific criteria. You have also not responded well to previous treatments for PTSD.You have used the drug 'Ecstasy' (which may contain MDMA) more than ten times in the past ten years, or within the past six months. Additionally, if you have taken part in a previous clinical trial involving MDMA sponsored by MAPS, you cannot participate.You have experienced combat in a recent war.I am not pregnant and agree to use birth control during the study.I am not pregnant, nursing, and I use effective birth control.You have a high risk of trying to harm yourself or needing to stay in the hospital during the study.If you have had frequent thoughts of self-harm within the past six months, or if you have had thoughts of self-harm more than once a week in the past month, you will not be able to participate.You must have experienced combat in the current war.I am currently in therapy for PTSD.You currently have an eating disorder.I agree to not take any unapproved drugs or supplements one week before an MDMA session.I am generally healthy with no major health issues.You have used ketamine within the past 12 weeks.I have major depression with psychotic symptoms.You are not medically stable or safe to go through alcohol detoxification outside of the hospital. You are at risk of severe alcohol withdrawal, or you are not willing or able to stop drinking alcohol for at least 72 hours before the experimental session.I have undergone ECT within the last 3 months.I have risk factors for a rare heart rhythm condition (like heart failure or low potassium).I am willing to stop taking psychiatric medications for the study, with doctor's guidance.I need medications that may affect my heart's rhythm during the trial.I have had low sodium levels or very high body temperature in the past.I agree not to drive myself home after an MDMA session.People who want to take part in the study must be veterans who are eligible for healthcare from the VA.I am between 18 and 55 years old.I am mentally able to understand and agree to my treatment plan.I am in psychotherapy and agree not to change therapists or therapy type during the study.I am between 18 and 55 years old.I am currently taking medication for my mental health.
Research Study Groups:
This trial has the following groups:- Group 1: Open Label
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.
Post-Traumatic Stress Disorder Patient Testimony for trial: Trial Name: NCT04264026 — Phase 2
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