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Psychedelic
MDMA-Assisted Therapy for PTSD
Phase 2
Waitlist Available
Led By Stephanie L Taylor, PhD
Research Sponsored by Stephen Robert Marder
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 visit 17 (approximately 14 weeks after enrollment)
Awards & highlights
Study Summary
This trial compares two treatments for PTSD: MDMA-assisted & d-amphetamine-assisted therapy. It tests safety & effectiveness of the treatments in adults with moderate-severe PTSD.
Who is the study for?
This trial is for veterans in the Greater Los Angeles area who have moderate to severe PTSD. Participants must be fluent in English, able to use effective contraception if applicable, and willing to have therapy sessions recorded. They should not be abusing drugs or involved in other clinical studies.Check my eligibility
What is being tested?
The study compares MDMA-assisted therapy with low dose d-amphetamine-assisted therapy for PTSD symptoms. It's a phase II trial where participants are randomly assigned to one of the two treatments without knowing which one they're receiving.See study design
What are the potential side effects?
Possible side effects may include anxiety, changes in mood, sleep disturbances, appetite changes, physical sensations like nausea or chills, and potential psychological distress related to confronting traumatic memories during therapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ visit 17 (approximately 14 weeks after enrollment)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~visit 17 (approximately 14 weeks after enrollment)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Compare changes in PTSD symptom severity in the MDMA vs active control group.
Secondary outcome measures
Compare changes in clinician-rated functional impairment in the MDMA vs active control group.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: MDMA-Assisted TherapyExperimental Treatment2 Interventions
Participants will receive a flexible divided-dose of MDMA plus therapy at Experimental Sessions.
Group II: Low Dose D-Amphetamine Assisted TherapyActive Control2 Interventions
Participants will receive a flexible divided dose plus therapy at Experimental Sessions.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Therapy
2014
Completed Phase 3
~990
3,4-methylenedioxymethamphetamine
2021
Completed Phase 1
~170
Find a Location
Who is running the clinical trial?
Stephen Robert MarderLead Sponsor
Stephanie L Taylor, PhDPrincipal InvestigatorVA Greater Los Angeles Healthcare System
Stephen Marder, MDPrincipal InvestigatorVA Greater Los Angeles Healthcare System
3 Previous Clinical Trials
356 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My high blood pressure is well-managed with medication.I agree to have my study visits, including therapy sessions, recorded.I am unable to understand or sign the consent form.I can have someone stay with me during my treatment nights if required.I can swallow pills.I weigh at least 45 kg and my BMI is between 18 and 32.I cannot or will not stop taking certain psychiatric medications.I may have Hepatitis C but it has been checked and treated if necessary.I am fluent in English.
Research Study Groups:
This trial has the following groups:- Group 1: MDMA-Assisted Therapy
- Group 2: Low Dose D-Amphetamine Assisted Therapy
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA sanctioned MDMA-Assisted Therapy?
"Previous studies have indicated some potential safety outcomes with MDMA-Assisted Therapy, thus granting it a score of 2. However, no clear efficacy data has been established yet."
Answered by AI
Are individuals still able to apply for this research endeavor?
"As confirmed on clinicaltrials.gov, this study is not presently seeking candidates. It was first posted to the platform in October of 2023 and last updated at the end of March that same year. Despite its current inactive status, there are currently 400 other studies actively looking for participants."
Answered by AI
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